46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05756179 (ClinicalTrials.gov) | July 2023 | 21/2/2023 | Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis | Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Diosmin and Hesperidin Combination | Alexandria University | NULL | Not yet recruiting | 19 Years | 65 Years | All | 80 | Phase 3 | NULL |
| 2 | NCT05622175 (ClinicalTrials.gov) | March 31, 2023 | 3/11/2022 | Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment | A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: F8IL10 | Philogen S.p.A. | NULL | Not yet recruiting | 18 Years | 80 Years | All | 32 | Phase 1 | NULL |
| 3 | NCT02903212 (ClinicalTrials.gov) | March 2023 | 1/9/2016 | Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis | Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Autologous apoptotic cells injection | Centre Hospitalier Universitaire de Besancon | NULL | Not yet recruiting | 18 Years | 80 Years | All | 22 | Phase 1/Phase 2 | NULL |
| 4 | NCT05540938 (ClinicalTrials.gov) | February 15, 2023 | 10/9/2022 | Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis | Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Wangbi granules;Drug: Wangbi granules simulant | China-Japan Friendship Hospital | Peking Union Medical College Hospital;The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine;The 980th Hospital of PLA Joint Logistics Support Force;The Second Affiliated Hospital of Zhejiang Chinese Medical University;Southwest Hospital, China | Not yet recruiting | 18 Years | 75 Years | All | 340 | Phase 4 | NULL |
| 5 | NCT05725434 (ClinicalTrials.gov) | February 6, 2023 | 2/2/2023 | A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis | A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P47 AI (tocilizumab);Biological: CT-P47 PFS (tocilizumab) | Celltrion | NULL | Not yet recruiting | 18 Years | 70 Years | All | 30 | Phase 3 | NULL |
| 6 | NCT05588817 (ClinicalTrials.gov) | December 30, 2022 | 18/10/2022 | Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis | Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Genetic: PCR polymorphism | Sohag University | NULL | Recruiting | 17 Years | 85 Years | Female | 90 | N/A | Egypt |
| 7 | NCT05545020 (ClinicalTrials.gov) | December 25, 2022 | 9/9/2022 | Trivalent Chromium Treatment for Rheumatoid Arthritis | Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Trivalent chromium versus synthetic and/ or biological DMARDs | Alexandria University | NULL | Recruiting | 18 Years | 80 Years | All | 60 | Phase 2/Phase 3 | Egypt |
| 8 | EUCTR2021-005771-39-CZ (EUCTR) | 20/12/2022 | 08/07/2022 | A clinical trial to investigate IRL201805 in patients with rheumatoid arthritis | A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis - RVLO 221-02 IRL201805 in rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: IRL201805 INN or Proposed INN: IRL201805 Other descriptive name: Modified BiP | Revolo Biotherapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 2 | Czechia;Hungary;Czech Republic;Spain;Poland;Georgia;Bulgaria;Germany;Latvia;United Kingdom | ||
| 9 | ITMCTR2200006853 | 2022-12-14 | 2022-12-06 | Clinical study on the treatment of advanced rheumatoid arthritis (Phlegm stasis bi syndrome) by Soufeng Sanjie fomula for inhibiting bone erosion | medicine | Rheumatoid arthritis | control group:MTX;Observation group:MTX+Traditional Chinese medicine (TCM); | Jiangsu Integrated Traditional Chinese and Western Medicine Hospital | NULL | Recruiting | 18 | 70 | Both | control group:30;Observation group:30; | China | |
| 10 | NCT05480878 (ClinicalTrials.gov) | December 2, 2022 | 23/7/2022 | Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis | Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Escitalopram 10mg | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 90 | Phase 3 | NULL |
| 11 | NCT04170426 (ClinicalTrials.gov) | December 2022 | 18/11/2019 | Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis | Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) | Rheumatoid Arthritis | Biological: autologous adipose derived stem cells | Celltex Therapeutics Corporation | NULL | Not yet recruiting | 18 Years | 75 Years | All | 54 | Phase 1/Phase 2 | NULL |
| 12 | NCT05428488 (ClinicalTrials.gov) | November 28, 2022 | 16/6/2022 | Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis | Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor. | Rheumatoid Arthritis | Drug: Abatacept (M3-M12);Drug: TNF Inhibitor (M3-M12);Drug: TNF Inhibitor (M0-M3) | University Hospital, Montpellier | NULL | Recruiting | 18 Years | 85 Years | All | 220 | Phase 3 | France |
| 13 | NCT05375942 (ClinicalTrials.gov) | November 11, 2022 | 11/5/2022 | This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry | Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra | Arthritis, Rheumatoid | Drug: Inflectra | Pfizer | NULL | Completed | 18 Years | N/A | All | 255 | United States | |
| 14 | NCT05594680 (ClinicalTrials.gov) | November 1, 2022 | 18/10/2022 | Cilostazol and Methotrexate in Rheumatoid Arthritis | The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Cilostazol;Drug: Methotrexate;Drug: Placebo | Tanta University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 70 | Phase 3 | NULL |
| 15 | NCT05533372 (ClinicalTrials.gov) | October 10, 2022 | 5/9/2022 | MAD Study of IA-14069 | Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IA-14069 in Healthy Subjects, With an Extension to Explore Any Drug-Drug Interaction Potential With Methotrexate (Part 1), and in Patients With Rheumatoid Arthritis, With Preliminary Assessment of Efficacy in Patients (Part 2) | Healthy;Rheumatoid Arthritis | Drug: IA-14069;Drug: Placebo;Drug: Methotrexate | ILAb Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | All | 75 | Phase 1 | United States |
| 16 | NCT05451615 (ClinicalTrials.gov) | September 30, 2022 | 17/6/2022 | Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis | Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Abatacept in Combination With a Janus Kinase (JAK) Inhibitor | Abatacept;Treatment Compliance;Rheumatoid Arthritis | Drug: Janus Kinase Inhibitor;Drug: Abatacept | Zhejiang Provincial People's Hospital | NULL | Recruiting | N/A | N/A | All | 90 | Phase 3 | China |
| 17 | NCT05660655 (ClinicalTrials.gov) | September 1, 2022 | 13/12/2022 | Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis | Efficacy and Safety of Baricitinib in Different Doses for the Treatment of Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Baricitinib 4 MG;Drug: Baricitinib 2 MG | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | NULL | Recruiting | 18 Years | N/A | All | 94 | Phase 4 | Bangladesh |
| 18 | NCT05516758 (ClinicalTrials.gov) | August 31, 2022 | 24/8/2022 | A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis | A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis;Arthritis;Joint Diseases;Musculoskeletal Diseases;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System Diseases | Drug: Peresolimab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 18 Years | N/A | All | 420 | Phase 2 | United States;Argentina;Canada;China;Greece;Hungary;Italy;Japan;Mexico;Poland;Puerto Rico;Spain |
| 19 | NCT05460832 (ClinicalTrials.gov) | August 29, 2022 | 12/7/2022 | Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA | A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: MBS2320 5 mg;Drug: MBS2320 20 mg;Drug: MBS2320 40 mg;Drug: Placebo | Modern Biosciences Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 224 | Phase 2 | Bosnia and Herzegovina;Bulgaria;Chile;Czechia;Guatemala;Mexico;Poland;Serbia |
| 20 | NCT05576597 (ClinicalTrials.gov) | August 23, 2022 | 7/10/2022 | Effect of Butyrate Supplement on Rheumatoid Arthritis | A Pilot Study to Evaluate Efficacy and Safety of Butyrate Supplement in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Sodium Butyrate | Peking University People's Hospital | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | China |
| 21 | NCT05274243 (ClinicalTrials.gov) | August 9, 2022 | 1/3/2022 | 2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis | 2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 2-HOBA;Other: Placebo | Vanderbilt University Medical Center | NULL | Recruiting | 18 Years | N/A | All | 32 | Phase 2 | United States |
| 22 | EUCTR2022-000169-42-CZ (EUCTR) | 18/07/2022 | 18/07/2022 | Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects with Moderate to Severe, Active Rheumatoid Arthritis with Inadequate Response or Intolerance to at Least One Biologic Disease modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | Rheumatoid arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: KPL-404 Other descriptive name: Human IgG4 monoclonal antibody against CD40 | Kiniksa Pharmaceuticals, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 99 | Phase 2 | Serbia;United States;Czechia;Hungary;Czech Republic;Poland;Lithuania;Georgia;Bulgaria;South Africa;Germany;United Kingdom | ||
| 23 | NCT05447520 (ClinicalTrials.gov) | July 15, 2022 | 1/7/2022 | Montelukast Use in Rheumatoid Arthritis | Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Montelukast;Drug: Placebo;Drug: Conventional DMARDs | Noha Mansour | NULL | Recruiting | 18 Years | 80 Years | All | 50 | Phase 2 | Egypt |
| 24 | NCT05392127 (ClinicalTrials.gov) | July 15, 2022 | 23/5/2022 | A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers | A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302 Tablets;Drug: Midazolam Maleate Tablets;Drug: Warfarin Sodium Tablets;Drug: Omeprazole Enteric Capsules;Drug: Vitamin K1 Tablets;Drug: Repaglinide Tablets | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 45 Years | Male | 24 | Phase 1 | China |
| 25 | ChiCTR2200058839 | 2022-07-01 | 2022-04-17 | Evaluation the efficacy and safety of reduced-dose adalimumab in Chinese patients with rheumatoid arthritis (RA): A Multicenter, prospective, parallel-group, real-world study | Evaluation the efficacy and safety of reduced-dose adalimumab in Chinese patients with rheumatoid arthritis (RA): A Multicenter, prospective, parallel-group, real-world study | Rheumatoid arthritis | No reduction group:Treatment of adalimumab;Extended cycle group, reduction group and drug withdrawal group:Treatment of adalimumab;Reduction group and drug withdrawal group:Treatment of adalimumab;Drug withdrawal group:Treatment of adalimumab; | The Second Affiliated Hospital Of Nanchang University | NULL | Pending | 18 | 70 | Both | No reduction group:73;Extended cycle group, reduction group and drug withdrawal group:96;Reduction group and drug withdrawal group:96;Drug withdrawal group:78; | Phase 4 | China |
| 26 | ITMCTR2200006086 | 2022-07-01 | 2022-06-10 | Multicenter randomized double-blind clinical trial of Qufeng Zhitong Capsule combined with Methotrexate tablets in the treatment of rheumatoid arthritis | Multicenter randomized double-blind clinical trial of Qufeng Zhitong Capsule combined with Methotrexate tablets in the treatment of rheumatoid arthritis | rheumatoid arthritis | matched group:Methotrexate tablet + qufeng analgesic capsule simulato;experimental group:Methotrexate tablet + qufeng analgesic capsule; | Guang 'anmen Hospital, China Academy of Traditional Chinese Medicine | NULL | Pending | 18 | 75 | Both | matched group:100;experimental group:100; | Phase 4 | China |
| 27 | NCT05379322 (ClinicalTrials.gov) | July 2022 | 12/5/2022 | The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients | The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Anti-TNF;Drug: JAK inhibitor | Abu Dhabi Stem Cells Center | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United Arab Emirates |
| 28 | NCT05165771 (ClinicalTrials.gov) | July 2022 | 8/12/2021 | Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Rheumatoid Arthritis | Drug: GS-5718;Drug: Placebo to match GS-5718;Drug: Tofacitinib 5 mg;Drug: Placebo to match Tofacitinib | Gilead Sciences | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 29 | NCT05404724 (ClinicalTrials.gov) | June 25, 2022 | 31/5/2022 | Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects | Study on the Pharmacokinetic Effects of Single-centered, Open, Single-arm, Fixed-sequence Itraconazole on SHR0302 Tablets in Healthy Subjects | Rheumatoid Arthritis | Drug: itraconazole? SHR0302 tablets | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 45 Years | Male | 14 | Phase 1 | China |
| 30 | NCT05092984 (ClinicalTrials.gov) | June 22, 2022 | 28/9/2021 | Evaluation of Spironolactone Efficacy in Patient With Rheumatoid Arthritis (RA) | Evaluation of Spironolactone Efficacy in Patient With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Spironolactone;Drug: Placebo | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 154 | Phase 3 | France |
| 31 | NCT05363891 (ClinicalTrials.gov) | June 15, 2022 | 2/5/2022 | Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis | Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Natrunix;Drug: Placebo | XBiotech, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 2 | NULL |
| 32 | NCT05363917 (ClinicalTrials.gov) | June 15, 2022 | 2/5/2022 | Natrunix Versus Methotrexate in Rheumatoid Arthritis | Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Natrunix with MTX placebo (+folate);Drug: Natrunix placebo with MTX (+folate) | XBiotech, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 2 | NULL |
| 33 | NCT05427942 (ClinicalTrials.gov) | June 3, 2022 | 17/6/2022 | Yuflyma® (Adalimumab), Patient Experience After Switching | YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study | Rheumatoid Arthritis;Ankylosing Spondylarthritis;Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis;Psoriatic Arthritis;Crohn Disease;Ulcerative Colitis | Drug: Adalimumab | Celltrion HealthCare France | NULL | Recruiting | 18 Years | N/A | All | 300 | France | |
| 34 | ITMCTR2200006093 | 2022-06-01 | 2022-06-11 | Evaluation of clinical efficacy of Lv's 'Shu Jin San' in the treatment of rheumatoid arthritis with cold-dampness syndrome | Evaluation of clinical efficacy of Lv's 'Shu Jin San' in the treatment of rheumatoid arthritis with cold-dampness syndrome | Rheumatoid Arthritis | therapy group:MTX 10mg po qw + Lv's Shu Jin San 15g po qd;control group:MTX 10mg po qw; | Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | NULL | Recruiting | 18 | 75 | Both | therapy group:18;control group:18; | China | |
| 35 | NCT05264025 (ClinicalTrials.gov) | June 1, 2022 | 10/1/2022 | Fexofenadine in Patients With Active Rheumatoid Arthritis | Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid | Rheumatoid Arthritis | Drug: Fexofenadine;Drug: Placebo | October 6 University | NULL | Recruiting | 18 Years | 60 Years | All | 80 | Phase 1/Phase 2 | Egypt |
| 36 | NCT05267431 (ClinicalTrials.gov) | June 2022 | 14/2/2022 | Outcomes of Biological Therapy on Rheumatoid Arthritis | Outcomes of Different Biological Therapy on Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Biological Drug | Sohag University | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Egypt | |
| 37 | JPRN-jRCTs051220027 | 25/05/2022 | 25/05/2022 | Examination of the efficacy of Peficitinib reduction in RA patients in sustained remission | Japan post-marketing study of Peficitinib use in RA patients (JASPER-reduction Study) | Rheumatoid arthritis;M0690 | RA patients who devided into into Peficitinib 150 mg and 100 mg groups, and their efficacy and safety will be examined among each group. | Hashimoto Motomu | NULL | Recruiting | >= 20age old | Not applicable | Both | 60 | N/A | Japan |
| 38 | NCT04269993 (ClinicalTrials.gov) | May 18, 2022 | 12/2/2020 | Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis | Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Cannabis: placebo and medium THC/medium CBD | Brown University | NULL | Recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | United States |
| 39 | NCT05323591 (ClinicalTrials.gov) | May 3, 2022 | 5/4/2022 | Prospective Observational Study of Filgotinib in Female Participants With Rheumatoid Arthritis in France | A Prospective, Non-interventional Study in Female Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years | Rheumatoid Arthritis | Drug: Filgotinib | Galapagos NV | NULL | Recruiting | 18 Years | N/A | Female | 150 | France | |
| 40 | NCT05380934 (ClinicalTrials.gov) | May 2022 | 16/5/2022 | A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects | A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects | Rheumatoid Arthritis | Drug: TQH3821 tablets;Drug: TQH3821 tablets (Placebo);Drug: Methotrexate tablets | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Recruiting | 18 Years | 55 Years | All | 62 | Phase 1 | China |
| 41 | NCT05246293 (ClinicalTrials.gov) | April 1, 2022 | 17/1/2022 | Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease. | Safety and Tolerability of Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease (RAILDTo Trial). | Rheumatoid Arthritis;Interstitial Lung Disease | Drug: Tofacitinib | National Institute of Respiratory Diseases, Mexico | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Mexico |
| 42 | NCT05166304 (ClinicalTrials.gov) | April 2022 | 8/12/2021 | Rebamipide in Patients With Active Rheumatoid Arthritis | Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rebamipide;Drug: Placebo | October 6 University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 100 | Phase 1/Phase 2 | NULL |
| 43 | JPRN-jRCT2071210132 | 23/03/2022 | 09/03/2022 | A single dose study in healthy Japanese participants to evaluate the safety and pharmacokinetics of otilimab. | A single center, single dose, open-label study in healthy Japanese participants to evaluate the safety, tolerability, and pharmacokinetics of otilimab. | Rheumatoid Arthritis | Single subcutaneous dose of otilimab | Yamada Masanori | NULL | Pending | >= 20age old | <= 50age old | Both | 12 | Phase 1 | Japan |
| 44 | NCT05424393 (ClinicalTrials.gov) | March 4, 2022 | 15/6/2022 | Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients | Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China | Rheumatoid Arthritis | Drug: YISAIPU® ( An etanercept biosimilar);Drug: csDMARDs | The First Affiliated Hospital of Xiamen University | NULL | Recruiting | 18 Years | 75 Years | All | 500 | China | |
| 45 | NCT05246280 (ClinicalTrials.gov) | March 2, 2022 | 16/12/2021 | Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFa Therapy Response in Moderate to Severe Active RA | Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: TC99m-tilmanocept | Navidea Biopharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 523 | Phase 3 | United States |
| 46 | NCT05379049 (ClinicalTrials.gov) | March 1, 2022 | 7/5/2022 | Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis. | Evaluation of the Therapeutic Response to TNF-alpha Antagonist (Etanercept, Infliximab, Adalimumab) in Patients With Rheumatoid Arthritis; Using Plasma TNF-alpha as a Competent Biomarker. Single Center Study in Sulaymaniyah/ Iraq | Rheumatoid Arthritis;Inflammatory Arthritis;Ankylosing Spondylitis | Biological: Infliximab: Adalimumab; Etanercept | University of Sulaimani | NULL | Recruiting | 18 Years | N/A | All | 80 | Iraq | |
| 47 | NCT05182203 (ClinicalTrials.gov) | March 1, 2022 | 18/12/2021 | Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience | Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience | Rheumatoid Arthritis;Drug Use | Drug: biologic/targeted therapy | Tuen Mun Hospital | NULL | Completed | 18 Years | N/A | All | 1732 | China | |
| 48 | ChiCTR2200057350 | 2022-02-25 | 2022-03-09 | Predictive value of TyG index and rheumatoid factor levels for cardiovascular disease risk in a population with rheumatoid arthritis | Predictive value of TyG index and rheumatoid factor levels for cardiovascular disease risk in a population with rheumatoid arthritis | rheumatoid arthritis | Gold Standard:Rheumatoid arthritis disease diagnosis is based on the ACR/EULAR criteria published in 2010 ;Index test:TyG index,rheumatoid factor; | China-Japan Friendship Hospital | NULL | Pending | 18 | 75 | Both | Target condition:150;Difficult condition:150 | China | |
| 49 | NCT05240859 (ClinicalTrials.gov) | February 22, 2022 | 6/2/2022 | Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis | A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Geleli | Peking University People's Hospital | NULL | Not yet recruiting | N/A | N/A | All | 1600 | China | |
| 50 | NCT05245448 (ClinicalTrials.gov) | February 22, 2022 | 22/1/2022 | Tetrandrine in the Treatment of Rheumatoid Arthritis | Comparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter Study | Rheumatoid Arthritis | Drug: Tetrandrine;Drug: Placebo | Peking University People's Hospital | NULL | Not yet recruiting | 18 Years | 65 Years | All | 240 | N/A | China |
| 51 | NCT05133297 (ClinicalTrials.gov) | February 16, 2022 | 15/11/2021 | The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis | A Phase 2A, Randomized, Double-blind, Double-dummy, Tofacitinib-parallel-group Study to Evaluate the Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Methotrexate. | Rheumatoid Arthritis | Drug: TLL-018;Drug: Tofacitinib | Hangzhou Highlightll Pharmaceutical Co., Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | China |
| 52 | EUCTR2021-004131-84-NL (EUCTR) | 14/02/2022 | 08/09/2021 | Comparing the effectiveness of tofacitinib extended release (XR) chronotherapy, morning versus evening dosing, in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients from a patient’s, clinical as well as a translational point of view. | Chronotherapy in Inflammatory Arthritis (ChronIA trial): a crossover randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release - ChronIA trial | Rheumatoid arthritis or psoriatic arthritis according to respectively 2010 criteria or CASPAR criteria MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz XR Product Name: Tofacitinib XR Product Code: EMEA/H/C/004214 | Erasmus Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 4 | Netherlands | ||
| 53 | NCT05671627 (ClinicalTrials.gov) | February 2, 2022 | 19/9/2022 | Cortisol Circadian Rhythm in Patients With RA | An Impaired Functional Reserve of Adrenal Cortex May Associate With difficult-to Treat RA: Can a Disturbed Cortisol Circadian Rhythm Serve as a Predictor of Difficult-to-treat RA? | Rheumatoid Arthritis | Drug: DMARDs | National and Kapodistrian University of Athens | NULL | Recruiting | 20 Years | 80 Years | All | 50 | Greece | |
| 54 | NCT05279417 (ClinicalTrials.gov) | February 2, 2022 | 18/2/2022 | ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA | ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Alone | Rheumatoid Arthritis | Drug: ATI-450 50mg oral tablet BID;Drug: Placebo oral tablet;Drug: Methotrexate;Drug: ATI-450 20mg oral tablet BID | Aclaris Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 2 | United States;Czechia;Poland |
| 55 | ChiCTR2100053221 | 2022-02-01 | 2021-11-16 | Effectiveness evaluation of the combined application of motor imagery and tai chi to alleviate the fear of falling in RA patients | Effectiveness evaluation of the combined application of motor imagery and tai chi to alleviate the fear of falling in RA patient | Rheumatoid Arthritis (RA) | group A:Routine nursing mode;group B:Motor imagery therapy;group C:Tai Chi balance three;group D:Movement imagination therapy + Tai Chi balance; | The Second Xiangya Hospital of Central South University | NULL | Recruiting | 18 | Both | group A:21;group B:21;group C:21;group D:21; | China | ||
| 56 | NCT04876781 (ClinicalTrials.gov) | January 12, 2022 | 20/4/2021 | Korean Post-marketing Surveillance for Xeljanz XR | Korean Post-marketing Surveillance for Xeljanz XR (Registered) | Active Moderate to Severe Rheumatoid Arthritis;Active Ankylosing Spondylitis | Drug: Tofacitinib XR | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 200 | Korea, Republic of | |
| 57 | EUCTR2020-000350-96-DE (EUCTR) | 11/01/2022 | 07/07/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 58 | NCT05053165 (ClinicalTrials.gov) | January 4, 2022 | 16/9/2021 | A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants | A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy Participants | Rheumatoid Arthritis;Non-Alcoholic Steatohepatitis | Drug: LB-P6;Drug: LB-P8;Drug: Placebo | LISCure Biosciences | NULL | Completed | 18 Years | 65 Years | All | 31 | Phase 1 | Australia |
| 59 | ChiCTR2200055292 | 2022-01-04 | 2022-01-05 | Correlation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatment | Correlation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatment | Rheumatoid Arthritis | Experimental group:Yisaipu combined with methotrexate and folic acid; | Peking University People's Hospital | NULL | Recruiting | 18 | 65 | Both | Experimental group:140; | Phase 4 | China |
| 60 | NCT05090124 (ClinicalTrials.gov) | January 1, 2022 | 20/7/2021 | Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis | Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Placebo | NHS Greater Glasgow and Clyde | University of Glasgow | Not yet recruiting | 18 Years | 74 Years | All | 50 | N/A | NULL |
| 61 | ChiCTR2100052492 | 2022-01-01 | 2021-10-29 | A clinical study on the treatment of refractory rheumatoid arthritis in combination with single Chinese medicine | A clinical study on the treatment of refractory rheumatoid arthritis in combination with single Chinese medicine | Rheumatoid Arthritis | Group 1:On the basis of traditional DMARD treatment, add traditional Chinese medicine Danshen tablets;Group 2:On the basis of traditional DMARD treatment, add traditional Chinese medicine Matrine tablets;Group 3:Add traditional Chinese medicine compound glycyrrhizin tablets on the basis of traditional DMARD treatment;Group 4:The traditional Chinese medicine aconitine injection is added to the traditional DMARD treatment; | The Second Affiliated Hospital of Guangxi Medical University | NULL | Pending | 18 | 80 | Both | Group 1:25;Group 2:25;Group 3:25;Group 4:25; | Phase 4 | China |
| 62 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 63 | NCT05153200 (ClinicalTrials.gov) | January 2022 | 29/11/2021 | Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study. | Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study. | Rheumatoid Arthritis | Drug: Upadacitinib;Drug: Adalimumab | Ottawa Hospital Research Institute | The Ottawa Hospital;University of Ottawa | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 4 | NULL |
| 64 | NCT05313061 (ClinicalTrials.gov) | December 29, 2021 | 28/12/2021 | MTX Hold During Covid-19 Booster | Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study | Rheumatoid Arthritis | Drug: MTX | Seoul National University Hospital | NULL | Recruiting | 19 Years | N/A | All | 40 | Phase 3 | Korea, Republic of |
| 65 | NCT05626348 (ClinicalTrials.gov) | December 22, 2021 | 15/11/2022 | The Clinical Efficacy of Immunomodulators in RA Patients | The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: Methotrexate;Drug: Adalimumab Injection;Drug: Leflunomide;Drug: Hydroxychloroquine | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 400 | Phase 4 | China |
| 66 | NCT05198310 (ClinicalTrials.gov) | December 14, 2021 | 3/1/2022 | Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | Arthritis, Rheumatoid | Drug: KPL-404;Drug: Placebo | Kiniksa Pharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 91 | Phase 2 | United States;Czechia |
| 67 | ChiCTR2100054220 | 2021-12-04 | 2021-12-11 | Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis related interstitial lung disease | Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis related interstitial lung disease | Rheumatoid arthritis related interstitial lung disease | Tofacitinib group:No;Traditional immunosuppressive therapy group:No; | Yantai Yuhuangding Hospital | NULL | Recruiting | 18 | 90 | Both | Tofacitinib group:30;Traditional immunosuppressive therapy group:30; | Phase 4 | Chian |
| 68 | ITMCTR2100005379 | 2021-12-01 | 2021-12-06 | Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription | Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription | Rheumatism | The treatment group:Simiaoxiaoling Zhiwang Decoction (granule) + methotrexate + folic acid tablets;The control group:methotrexate + folic acid tablets; | Yunnan Hospital of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | The treatment group:36;The control group:36; | China | |
| 69 | EUCTR2020-005303-39-IT (EUCTR) | 01/12/2021 | 12/10/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/orTargeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: [ABBV-154] INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: [ABBV-154] INN or Proposed INN: ABBV-154 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 70 | ChiCTR2100054305 | 2021-12-01 | 2021-12-13 | Observation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heat | Observation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heat | Rheumatoid Arthritis | Treatment group:Modified Qianyang Fengsui Dan + Methotrexate Tablets + Folic Acid Tablets;Control group:Methotrexate + Folic Acid; | Yunnan Provincial Hospital of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Treatment group:36;Control group:36; | China | |
| 71 | ChiCTR2100053999 | 2021-12-01 | 2021-12-06 | Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription | Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription | Rheumatism | Experimental group:Simiaoxiaoling Zhiwang Decoction (granule) + methotrexate + folic acid tablets;Control group:methotrexate + folic acid tablets; | Yunnan Hospital of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Experimental group:36;Control group:36; | China | |
| 72 | ChiCTR2100053713 | 2021-12-01 | 2021-11-28 | The efficacy and safety of Abatacept in the treatment of antinuclear antibody (ANA) positive rheumatoid arthtits patients | The efficacy and safety of Abatacept (ABA) in the treatment of patients with antinuclear antibody (ANA) positive active rheumatoid arthritis: a multi-center, prospective, open study | rheumatoid arthritis | Experimental group:Abatacept 125mg SC each week; | The First Affiliated Hospital of Wenzhou Medical University | NULL | Recruiting | 18 | 65 | Both | Experimental group:60; | Phase 4 | China |
| 73 | NCT05152615 (ClinicalTrials.gov) | November 17, 2021 | 1/12/2021 | A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA) | A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA) | Rheumatoid Arthritis | Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement | NYU Langone Health | NULL | Recruiting | 18 Years | N/A | All | 50 | N/A | United States |
| 74 | EUCTR2020-005303-39-NL (EUCTR) | 11/11/2021 | 28/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 75 | JPRN-jRCT2071210068 | 09/11/2021 | 28/09/2021 | Abatacept vs Adalimumab in Early, Seropositive, and SE-positive RA | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Single-blind Treatment Period Arm A Abatacept+MTX Arm B Adalimumab+MTX Open-label Treatment Period Abatacept+MTX | Maldonado A Michael | NULL | Recruiting | >= 20age old | Not applicable | Both | 20 | Phase 3 | Australia;France;Germany;USA;Taiwan;Japan |
| 76 | NCT05003934 (ClinicalTrials.gov) | November 7, 2021 | 6/8/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Recruiting | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda;Argentina;Mexico |
| 77 | EUCTR2020-005303-39-SK (EUCTR) | 04/11/2021 | 16/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 78 | EUCTR2020-005303-39-PL (EUCTR) | 02/11/2021 | 26/08/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 79 | NCT04834557 (ClinicalTrials.gov) | November 1, 2021 | 2/4/2021 | Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis | Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt | Rheumatoid Arthritis | Drug: Placebo;Drug: Digoxin 0.25 mg;Drug: Ursodeoxycholic acid (UDCA) 500 mg | Tanta University | NULL | Recruiting | 18 Years | 80 Years | All | 90 | Phase 2 | Egypt |
| 80 | EUCTR2020-005303-39-DE (EUCTR) | 26/10/2021 | 07/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 473 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 81 | EUCTR2020-005303-39-GR (EUCTR) | 21/10/2021 | 13/09/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 82 | EUCTR2020-002765-34-BE (EUCTR) | 21/10/2021 | 24/08/2021 | A Study Comparing MabionCD20 (new Rituximab biosimilar) with MabThera (reference Rituximab from EU) and Rituxan (reference Rituximab from US) in Patients with Rheumatoid Arthritis | A Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20 (manufactured in commercial scale), EU-approved MabThera® and US-licensed Rituxan® in Patients with Moderate-to-Severe Rheumatoid Arthritis - MABRIDGE | Moderate-to-severe rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MabionCD20 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan INN or Proposed INN: RITUXIMAB | Mabion S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Serbia;Poland;Belgium;Ukraine;Bulgaria;Georgia | ||
| 83 | NCT04985812 (ClinicalTrials.gov) | October 18, 2021 | 6/7/2021 | A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis | A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: JNJ-67484703;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 47 | Phase 1 | United States;Georgia;Hungary;Moldova, Republic of;Spain;Ukraine |
| 84 | NCT04680962 (ClinicalTrials.gov) | October 17, 2021 | 2/12/2020 | MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis | A Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20, EU-approved MabThera® and US-licensed Rituxan® in Patients With Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: MabionCD20 (candidate biosimilar to rituximab);Biological: MabThera®;Biological: Rituxan® | Mabion SA | Parexel | Not yet recruiting | 18 Years | 80 Years | All | 280 | Phase 3 | NULL |
| 85 | NCT04991753 (ClinicalTrials.gov) | October 14, 2021 | 2/8/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy | Arthritis, Rheumatoid | Other: Placebo;Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 75 Years | All | 53 | Phase 2 | United States;Germany;Poland;Spain;United Kingdom |
| 86 | NCT04844008 (ClinicalTrials.gov) | October 5, 2021 | 30/3/2021 | Do Nanobubbles Improve Joint Hypoxia? | An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia? | Rheumatoid Arthritis;Psoriatic Arthritis | Dietary Supplement: Nanobubble drink | University of Oxford | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United Kingdom |
| 87 | EUCTR2021-000510-42-DE (EUCTR) | 05/10/2021 | 16/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Spain;Poland;Germany;United Kingdom | ||
| 88 | NCT04911127 (ClinicalTrials.gov) | October 5, 2021 | 14/5/2021 | Therapeutic Response of Cannabidiol in Rheumatoid Arthritis | Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis;Cannabis | Drug: 200mg Cannabidiol by capsules twice daily;Drug: 400mg Cannabidiol by capsules twice daily;Drug: Placebo capsules | University of California, Los Angeles | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | United States |
| 89 | NCT05069714 (ClinicalTrials.gov) | October 1, 2021 | 26/9/2021 | One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis. | Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial | Rheumatoid Arthritis;Autoimmune Diseases;Influenza;Vaccine Reaction | Drug: MTX-hold | Seoul National University Hospital | NULL | Completed | 19 Years | N/A | All | 184 | Phase 3 | Korea, Republic of |
| 90 | ChiCTR2100048769 | 2021-09-29 | 2021-07-16 | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | rheumatoid arthritis | Test group:Methotrexate tablets+Qufengzhitong capsule;control group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 75 | Both | Test group:102;control group:102; | Phase 4 | china |
| 91 | ITMCTR2100005057 | 2021-09-29 | 2021-07-16 | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | rheumatoid arthritis | control group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo;Test group:Methotrexate tablets+Qufengzhitong capsule; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 75 | Both | control group:102;Test group:102; | Phase 4 | china |
| 92 | EUCTR2020-000350-96-IT (EUCTR) | 21/09/2021 | 22/10/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate - - | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: [BMS-188667] INN or Proposed INN: abatacept Trade Name: Humira Product Name: ADALIMUMAB Product Code: [-] | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 93 | EUCTR2021-000510-42-ES (EUCTR) | 17/09/2021 | 09/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. - IRIS | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Poland;Spain;Germany;United Kingdom | ||
| 94 | NCT04909801 (ClinicalTrials.gov) | September 15, 2021 | 28/5/2021 | A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | N/A | All | 300 | Phase 3 | Taiwan;United Kingdom;United States;Argentina;Australia;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Spain;Switzerland |
| 95 | NCT04078191 (ClinicalTrials.gov) | September 14, 2021 | 21/8/2019 | Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA) | A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Tc 99m tilmanocept | Navidea Biopharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States;United Kingdom |
| 96 | NCT05039216 (ClinicalTrials.gov) | September 13, 2021 | 6/9/2021 | Biobank for Inflammatory Chronic Diseases and Osteoporosis | Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse | Rheumatoid Arthritis;Psoriatic Arthritis;Spondyloarthritis;Osteoporosis | Biological: Blood sampling | University Hospital, Toulouse | NULL | Recruiting | 18 Years | 99 Years | All | 2000 | France | |
| 97 | EUCTR2020-005303-39-ES (EUCTR) | 31/08/2021 | 02/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 98 | EUCTR2020-000350-96-PL (EUCTR) | 24/08/2021 | 19/07/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 99 | EUCTR2021-001560-14-ES (EUCTR) | 13/08/2021 | 11/06/2021 | Use of tofacitinib in patients with treatment-refractory rheumatoid arthritis. | Single-center, open-label, uncontrolled clinical trial to evaluate the association between the expression of the JAK / STAT pathway and the response to tofacitinib in patients with refractory rheumatoid arthritis. | Refractory rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ INN or Proposed INN: TOFACITINIB | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 4 | Spain | ||
| 100 | EUCTR2020-000350-96-FR (EUCTR) | 09/08/2021 | 28/05/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 101 | EUCTR2020-000350-96-CZ (EUCTR) | 02/08/2021 | 10/06/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 102 | NCT05651373 (ClinicalTrials.gov) | July 30, 2021 | 15/11/2022 | The Clinical Features and Pregnancy Outcomes of RA Patients | The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study | Rheumatoid Arthritis;Pregnancy Related | Drug: Prednisone;Drug: Hydroxychloroquine;Drug: CertolizumabPegol injection | Qilu Hospital of Shandong University | NULL | Recruiting | 20 Years | 45 Years | Female | 100 | China | |
| 103 | EUCTR2020-000350-96-ES (EUCTR) | 29/07/2021 | 23/06/2021 | Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate | A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 104 | ChiCTR2100048795 | 2021-07-17 | 2021-07-16 | Evidence based evaluation of a synergistic protocol for Chinese and Western medicine in active rheumatoid arthritis | Evidence based evaluation of a synergistic protocol for Chinese and Western medicine in active rheumatoid arthritis | Rheumatoid Arthritis | Western Medicine Group:Methotrexate and other traditional DMARDs treatment;The combination of Chinese and Western Medicine Group:Western medicine +Modified Yunpi Jiedu Tongluo Qushi granule based on syndrome differentiation; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | Western Medicine Group:659;The combination of Chinese and Western Medicine Group:659; | N/A | China |
| 105 | ITMCTR2200005771 | 2021-07-17 | 2021-07-16 | Evidence based evaluation of a synergistic protocol for Chinese and Western medicine in active rheumatoid arthritis | Evidence based evaluation of a synergistic protocol for Chinese and Western medicine in active rheumatoid arthritis | Rheumatoid Arthritis | The combination of Chinese and Western Medicine Group:Western medicine +Modified Yunpi Jiedu Tongluo Qushi granule based on syndrome differentiation;Western Medicine Group:Methotrexate and other traditional DMARDs treatment; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | The combination of Chinese and Western Medicine Group:659;Western Medicine Group:659; | N/A | China |
| 106 | ITMCTR2100005066 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | Rheumatoid arthritis with interstitial pneumonia | control group:Hydroxychloroquine + prednisone;experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | control group:240;experimental group:285; | N/A | China |
| 107 | ChiCTR2100048802 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | Rheumatoid arthritis with interstitial pneumonia | experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules;control group:Hydroxychloroquine + prednisone; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | experimental group:285;control group:240; | N/A | China |
| 108 | ChiCTR2100048185 | 2021-07-01 | 2021-07-04 | The efficacy and safety of Tofacitinib in the treatment of DMARDS naive rheumatoid arthtits patients | The efficacy and safety of Tofacitinib virus MTX in the treatment of DMARDS naive rheumatoid arthtits patients--a randomized controlled trial | Rheumatoid Arthritis | Experimental group:Tofacitinib 5mg twice per day;Control group:Methotrexate; | Peking University First Hospital | NULL | Pending | 18 | Both | Experimental group:112;Control group:112; | Phase 4 | China | |
| 109 | NCT05117593 (ClinicalTrials.gov) | June 28, 2021 | 23/9/2021 | Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX | Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects | Rheumatoid Arthritis | Drug: FBL-MTX;Drug: Placebo | SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | Portugal |
| 110 | NCT04909931 (ClinicalTrials.gov) | June 15, 2021 | 11/5/2021 | Vitamin D Supplementation on Outcome and Disease Activity. | Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients at Rajavithi Hospital : A Randomized Clinical Trial | Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR | Drug: Vitamin D 2;Drug: Placebo | Rajavithi Hospital | NULL | Recruiting | 18 Years | N/A | All | 60 | N/A | Thailand |
| 111 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 112 | NCT04888585 (ClinicalTrials.gov) | June 2, 2021 | 13/5/2021 | Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | Rheumatoid Arthritis (RA) | Drug: ABBV-154;Drug: Placebo | AbbVie | NULL | Active, not recruiting | 18 Years | 75 Years | All | 473 | Phase 2 | United States;Australia;Canada;Czechia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;France;United Kingdom |
| 113 | NCT04885751 (ClinicalTrials.gov) | June 1, 2021 | 26/4/2021 | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy | Drug: Eupatilin;Drug: Rebamipide | Seoul National University Boramae Hospital | Dong-A ST Co., Ltd. | Not yet recruiting | 19 Years | 70 Years | All | 50 | Phase 4 | NULL |
| 114 | NCT05078502 (ClinicalTrials.gov) | June 1, 2021 | 4/10/2021 | Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs(csDMARD) in Rheumatoid Arthritis Patients | Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARD) in Rheumatoid Arthritis Patients: Randomized Double-blind Placebo Controlled Trial | Rheumatoid Arthritis | Dietary Supplement: Vitamin D3 | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | NULL | Completed | 18 Years | 70 Years | All | 58 | N/A | Bangladesh |
| 115 | EUCTR2020-005096-12-SE (EUCTR) | 31/05/2021 | 09/04/2021 | Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studie | Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad reumatoid artrit: en randomiserad, öppen, non-inferiority klinisk studie | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisolon Pfizer Product Name: Prednisolon Pfizer INN or Proposed INN: PREDNISOLONE | Karolinska Universitetssjukhuset | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 4 | Sweden | ||
| 116 | NCT04927000 (ClinicalTrials.gov) | May 31, 2021 | 31/5/2021 | The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis | The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tofacitinib | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 30 Years | 65 Years | Female | 170 | Phase 4 | China |
| 117 | ChiCTR2100046283 | 2021-05-30 | 2021-05-12 | Study on the mechanism of pirfenidone in the treatment of connective tissue disease with interstitial lung disease | Study on the mechanism of pirfenidone in the treatment of connective tissue disease with interstitial lung disease | rheumatoid arthritis | Experimental group:pirfenidone; | The First Affiliated Hospital of DaLian Medical University | NULL | Pending | 18 | 70 | Both | Experimental group:100; | Phase 4 | China |
| 118 | ChiCTR2100048699 | 2021-05-25 | 2021-07-12 | A multicentre, randomized, parallel-controlled clinical study of the efficacy and safety of Iguratimod combination therapy with JAK inhibitor in the treatment of csDMARDs-IR active rheumatoid arthritis | Clinical cohort study of organ injury and repair in severe rheumatic diseases---rheumatoid arthritis | Rheumatoid Arthritis | A:Iguratimod combination therapy with JAK inhibitor;B:JAK inhibitor; | Qilu Hospital of Shandong University | NULL | Recruiting | 18 | 65 | Both | A:180;B:180; | China | |
| 119 | JPRN-jRCTs071200107 | 25/05/2021 | 03/03/2021 | Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial | Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial | Rheumatoid arthritis | In patients with active RA for whom continuous MTX treatment (including other concurrent csDMARDs) for at least 8 weeks is ineffective, treatment will be switched to filgotinib monotherapy or tocilizumab monotherapy. MTX (including other concomitant csDMARDs) will be discontinued at baseline. Patients who satisfy the eligibility criteria will be randomly allocated to the filgotinib treatment group or the tocilizumab group (ratio of 1:1). The patients in each group will receive each respective drug for 52 weeks. The proportion of patients who reach an American College of Rheumatology 50% improvement response (ACR50) at 12 weeks after commencement of filgotinib monotherapy or tocilizumab monotherapy will be defined as the primary endpoint, and will serve as evidence of the noninferiority of filgotinib monotherapy compared with tocilizumab monotherapy. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 400 | N/A | Japan |
| 120 | ChiCTR2100046373 | 2021-05-15 | 2021-05-15 | Clinical study on the therapeutic effect of Juanbi Qianggu Formula combined with DMARDs on Rheumatoid Arthritis with liver and kidney deficiency | Clinical study on the therapeutic effect of Juanbi Qianggu Formula combined with DMARDs on Rheumatoid Arthritis with liver and kidney deficiency | rheumatoid arthritis | Experimental group:Methotrexate 10mg qw+ Juanbiqianggu prescription 1 bag of tid;Control group:Methotrexate 10mg qw; | Shanghai Guanghua Integrated traditional Chinese and Western Medicine Hospital | NULL | Recruiting | Both | Experimental group:40;Control group:40; | China | |||
| 121 | ITMCTR2100004848 | 2021-05-15 | 2021-05-15 | Clinical study on the therapeutic effect of Juanbi Qianggu Formula combined with DMARDs on Rheumatoid Arthritis with liver and kidney deficiency | Clinical study on the therapeutic effect of Juanbi Qianggu Formula combined with DMARDs on Rheumatoid Arthritis with liver and kidney deficiency | rheumatoid arthritis | Control group:Methotrexate 10mg qw;Experimental group:Methotrexate 10mg qw+ Juanbiqianggu prescription 1 bag of tid; | Shanghai Guanghua Integrated traditional Chinese and Western Medicine Hospital | NULL | Recruiting | Both | Control group:40;Experimental group:40; | China | |||
| 122 | NCT04884880 (ClinicalTrials.gov) | May 14, 2021 | 30/4/2021 | Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis | Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Luo-Fu-Shan Plaster;Drug: The placebo 10g | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Not yet recruiting | 18 Years | 75 Years | All | 180 | N/A | China |
| 123 | NCT04947137 (ClinicalTrials.gov) | May 12, 2021 | 10/5/2021 | Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept | Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept | Rheumatoid Arthritis | Drug: Tc99m tilmanocept | Navidea Biopharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 135 | Phase 2 | United States |
| 124 | NCT04871919 (ClinicalTrials.gov) | May 11, 2021 | 29/4/2021 | Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis | A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib | Rheumatoid Arthritis | Drug: Filgotinib | Galapagos NV | NULL | Recruiting | 18 Years | N/A | All | 1500 | Belgium;Germany;Italy;Netherlands;Spain;United Kingdom | |
| 125 | NCT04815148 (ClinicalTrials.gov) | April 1, 2021 | 19/3/2021 | MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis | A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and PK of MH004 Topical Cream in Healthy Adult Volunteers and to Investigate Its Efficacy and Safety Profile in Participants With Atopic Dermatitis or Rheumatoid Arthritis | Atopic Dermatitis;Rheumatoid Arthritis | Drug: MH004 Ia(0.1%);Drug: MH004 Ia(0.3%);Drug: MH004 Ia(1%);Drug: MH004 Ia(3%);Drug: MH004 Ib-1(0.1%);Drug: MH004 Ib-1(0.3%);Drug: MH004 Ib-1(1%);Drug: MH004 Ib-2(0.3%);Drug: MH004 Ib-2(1%);Drug: MH004 Ib-2(3%) | Minghui Pharmaceutical Pty Ltd | NULL | Not yet recruiting | 18 Years | 70 Years | All | 72 | Phase 1 | NULL |
| 126 | NCT05247216 (ClinicalTrials.gov) | March 26, 2021 | 31/5/2021 | A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Hemay007 in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hemay007 800 mg QD group;Drug: Hemay007 1200 mg QD group;Drug: Hemay007 600 mg QD group;Drug: Hemay007 placebo group | Tianjin Hemay Pharmaceutical Co.,Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 2 | China |
| 127 | JPRN-jRCTs071200079 | 22/03/2021 | 12/01/2021 | Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments | Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments | Rheumatoid arthritis | Starting at baseline (week 0), all patients will receive upadacitinib 15mg/day and continue to receive a stable pre-baseline dosage of MTX until week 24 (Stage I). In addition, if patients achieve a EULAR moderate response or a DAS28-CRP <= 3.2 a week 12, and a DAS28-CRP of < 2.6 at week 24, they will discontinue MTX, and continue upadacitinib monotherapy until week 48 (Stage II). Patients not achieving a EULAR moderate response or a DAS28-CRP <= 3.2 at week 12 or a DAS28-CRP of < 2.6 at week 24 will be excluded from this study. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 155 | Phase 4 | Japan |
| 128 | NCT04286789 (ClinicalTrials.gov) | March 22, 2021 | 25/2/2020 | Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs | A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs | Rheumatoid Arthritis | Drug: Low dose ORTD-1;Drug: Low dose vehicle control;Drug: High dose ORTD-1;Drug: High dose vehicle control | Oryn Therapeutics, LLC | NULL | Completed | 18 Years | N/A | All | 17 | Phase 1 | United States |
| 129 | EUCTR2021-000710-42-NL (EUCTR) | 15/03/2021 | 08/03/2021 | Research into the effect of the COVID-vaccine in patients who are treated with rituximab (RTX-COVAC study) | The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study. - RTX-COVAC | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Comirnaty Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca | Sint Maartenskliniek | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 4 | Netherlands | ||
| 130 | NCT04559412 (ClinicalTrials.gov) | March 15, 2021 | 3/9/2020 | Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis | Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Device: Sofusa DoseConnect;Drug: Enbrel | Sorrento Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 11 | Phase 1 | United States |
| 131 | EUCTR2020-005998-27-DK (EUCTR) | 12/03/2021 | 25/01/2021 | Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis. | Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 23.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Product Name: Kevzara INN or Proposed INN: SARILUMAB Other descriptive name: Sarilumab Product Name: Kevzara INN or Proposed INN: SARILUMAB Other descriptive name: Sarilumab | University of Southern Denmark | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 1;Phase 2 | Denmark | ||
| 132 | EUCTR2021-000880-63-SE (EUCTR) | 11/03/2021 | 23/02/2021 | COVID-19 vaccine in patients with rheumatic diseases: The impact of treatments on the vaccine response protection against infection (COVID19-REUMA) | COVID-19 vaccine in patients with inflammatory rheumatic diseases: The impact of immunomodulating treatments on the antibody response, T cells response and protection against infection (COVID19-REUMA) - COVID19-REUMA | rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Comirnaty Product Name: Comirnaty INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified) Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19) Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) | Skåne University Hospital, department of rheumatology in Lud and Malmö | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 868 | Phase 4 | Sweden | ||
| 133 | NCT04798287 (ClinicalTrials.gov) | March 10, 2021 | 11/3/2021 | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: TNF Inhibitor | Brigham and Women's Hospital | NULL | Completed | 18 Years | N/A | All | 105711 | United States | |
| 134 | EUCTR2020-005773-27-FR (EUCTR) | 09/03/2021 | 19/01/2021 | BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE | BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE - BARICENTRE | Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: OLUMIANT 4 mg Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: OLUMIANT 4mg Product Name: Baricitinib INN or Proposed INN: BARICITINIB | ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | France | ||
| 135 | JPRN-UMIN000043547 | 2021/03/08 | 08/03/2021 | Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. | Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. - Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. | Rheumatoid Arthritis | 60 weeks Oral administration of 200mg filgotinib daily | DeparShinshu University School of Medicine | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan |
| 136 | ChiCTR2100044045 | 2021-03-08 | 2021-03-09 | Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasis | Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasis | Immune-Mediated Inflammatory Diseases | Case series:Adalimumab; | Mianyang Hospital of Traditional Chinese Medicine | NULL | Recruiting | Both | Case series:50; | Phase 4 | China | ||
| 137 | EUCTR2020-002673-10-PL (EUCTR) | 04/03/2021 | 19/02/2021 | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Czechia;Czech Republic;Hungary;Mexico;Poland;United Kingdom | ||
| 138 | NCT05232396 (ClinicalTrials.gov) | March 2, 2021 | 25/11/2021 | Clinical Study of a IL-6R Injection in Patients With RA | Phase Ib Clinical Study of Safety and Tolerability , PK/PD Parameters and Preliminary Efficiency of a IL-6R Injection Monoclonal Antibody Injection in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: IL-6R Monoclonal Antibody Injection 4mg/kg;Biological: IL-6R Monoclonal Antibody Injection 6mg/kg;Biological: IL-6R Monoclonal Antibody Injection 8mg/kg;Biological: Tocilizumab Injection 8mg/kg | Beijing VDJBio Co., LTD. | NULL | Completed | 18 Years | 70 Years | All | 40 | Phase 1/Phase 2 | China |
| 139 | EUCTR2020-002673-10-HU (EUCTR) | 02/03/2021 | 29/12/2020 | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Czechia;Czech Republic;Hungary;Mexico;Poland;United Kingdom | ||
| 140 | NCT04117165 (ClinicalTrials.gov) | March 1, 2021 | 30/9/2019 | Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis | Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid;Biological Therapy | Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care | University Hospital, Grenoble | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | N/A | France |
| 141 | NCT04772248 (ClinicalTrials.gov) | February 22, 2021 | 23/2/2021 | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: TNF Inhibitor | Brigham and Women's Hospital | NULL | Completed | 18 Years | N/A | All | 105711 | United States | |
| 142 | EUCTR2020-002673-10-CZ (EUCTR) | 17/02/2021 | 28/12/2020 | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Czechia;Hungary;Czech Republic;Mexico;Poland;United Kingdom | ||
| 143 | EUCTR2019-004369-42-DE (EUCTR) | 15/02/2021 | 27/11/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | Serbia;United States;Czechia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Poland;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 144 | EUCTR2020-000462-41-SE (EUCTR) | 09/02/2021 | 11/01/2021 | Is there a difference in efficacy, tolerability and preferences between methotrexate given as tablets or given as injections in patients with early rheumatoid arthritis – a randomized register based multicenter study | Efficacy, tolerability and preferences of peroral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomized register based multicenter study | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Västerbotten county | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 212 | Phase 4 | Sweden | ||
| 145 | NCT04757571 (ClinicalTrials.gov) | February 1, 2021 | 12/2/2021 | The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients | The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. | Rheumatoid Arthritis | Drug: Paroxetine;Drug: Placebo | Sadat City University | NULL | Recruiting | 18 Years | 60 Years | All | 120 | Phase 1/Phase 2 | Egypt |
| 146 | JPRN-jRCTs071200007 | 28/01/2021 | 20/04/2020 | Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments | Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments | Rheumatoid arthritis | Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 80 | Phase 4 | Japan |
| 147 | ChiCTR2100042659 | 2021-01-25 | 2021-01-25 | Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation | Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation | Rheumatoid Arthritis | experimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets;control group:Methotrexate tablets + Folic acid tablets; | The Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | experimental group:36;control group:36; | China | |
| 148 | ITMCTR2100004321 | 2021-01-25 | 2021-01-25 | Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation | Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation | Rheumatoid Arthritis | control group:Methotrexate tablets + Folic acid tablets;experimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets; | The Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | control group:36;experimental group:36; | China | |
| 149 | ChiCTR2100042440 | 2021-01-21 | 2021-01-21 | Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene | Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene | difficult-to-treat rheumatoid arthritis | The normal group:No special treatment; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant; | Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | The normal group:15; Primary untreated group:15;Therapeutic effective group:15;Refractory (trial group):15;Refractory (control group):15; | China | |
| 150 | ITMCTR2100004302 | 2021-01-21 | 2021-01-21 | Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene | Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene | difficult-to-treat rheumatoid arthritis | The normal group:No special treatment;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan; | Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | The normal group:15;Refractory (control group):15;Refractory (trial group):15; Primary untreated group:15;Therapeutic effective group:15; | China | |
| 151 | ITMCTR2100004288 | 2021-01-19 | 2021-01-19 | Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene | Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene | Rheumatoid arthritis | Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;The normal group:No special treatment will be given; | Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine) | NULL | Recruiting | 18 | 70 | Both | Observation group:15;Primary untreated group:15;Therapeutic effective group:15;The control group:15;The normal group:15; | China | |
| 152 | ITMCTR2100004290 | 2021-01-19 | 2021-01-19 | Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism | Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism | rheumatoid arthritis | Intervention group:Folic Acid;control group:Calcitriol Soft Capsules;Intervention group:Calcitriol Soft Capsules;control group:MTX;control group:Folic Acid;Intervention group:Huangqijishengtang+Calcitriol Soft Capsules+MTX;Intervention group:MTX;control group:Simulator of Huangqijishengtang;;12122112 | The Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Intervention group:38;control group:38;Intervention group:38;control group:38;control group:38;Intervention group:38;Intervention group:38;control group:38; | China | |
| 153 | ChiCTR2100042328 | 2021-01-19 | 2021-01-19 | Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene | Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene | Rheumatoid arthritis | The normal group:No special treatment will be given;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent; | Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine) | NULL | Recruiting | 18 | 70 | Both | The normal group:15;Primary untreated group:15;Therapeutic effective group:15;Observation group:15;The control group:15; | China | |
| 154 | ChiCTR2100042329 | 2021-01-19 | 2021-01-19 | Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism | Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism | rheumatoid arthritis | Intervention group:Huangqijishengtang+Calcitriol Soft Capsules+MTX;Intervention group:Calcitriol Soft Capsules;Intervention group:MTX;Intervention group:Folic Acid;control group:Simulator of Huangqijishengtang;control group:Calcitriol Soft Capsules;control group:MTX;control group:Folic Acid; | The Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Intervention group:38;Intervention group:38;Intervention group:38;Intervention group:38;control group:38;control group:38;control group:38;control group:38; | China | |
| 155 | EUCTR2019-000878-30-DE (EUCTR) | 18/01/2021 | 28/05/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Serbia;United States;Philippines;Estonia;Spain;Thailand;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Czechia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan | ||
| 156 | NCT04539964 (ClinicalTrials.gov) | January 11, 2021 | 31/8/2020 | Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis | Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study | Rheumatoid Arthritis | Procedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Non-active stimulation | SetPoint Medical Corporation | NULL | Recruiting | 22 Years | 75 Years | All | 250 | Phase 3 | United States |
| 157 | NCT04530305 (ClinicalTrials.gov) | January 7, 2021 | 24/8/2020 | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Rheumatoid Arthritis | Drug: Tofacitinib 5 MG [Xeljanz] | University Hospital, Montpellier | NULL | Recruiting | 18 Years | N/A | All | 60 | France | |
| 158 | ITMCTR2100004658 | 2021-01-01 | 2021-01-09 | Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain | Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain | Rheumatoid arthritis | therapy group:Yiyisise ointment, Methotrexate, Leflunomide tablets and Folic acid tablets ;Control group:Yiyisise ointment simulant, Methotrexate, Leflunomide tablets and Folic acid tablets; | Yunnan Hospital of Traditional Chinese Medicine | NULL | Recruiting | Both | therapy group:36;Control group:36; | China | |||
| 159 | ITMCTR2100004610 | 2021-01-01 | 2021-01-05 | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | rheumatoid arthritis | control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide;Treatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ; | Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | control group:31;Treatment group:62; | China | |
| 160 | ChiCTR2000036164 | 2021-01-01 | 2020-08-21 | Effects of dexmedetomidine on periarticular infiltration analgesia in total hip arthroplasty: a prospective, double-blind, randomized controlled trial | Effects of dexmedetomidine on periarticular infiltration analgesia in total hip arthroplasty: a prospective, double-blind, randomized controlled trial | knee osteoarthritis/ knee rheumatoid arthritis | A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine ; | West China Hospital, Sichuan University | NULL | Pending | 18 | 80 | Both | A:40;B:40; | china | |
| 161 | ChiCTR2100041909 | 2021-01-01 | 2021-01-09 | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Rheumatoid arthritis | Treatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide; | Yunnan Traditional Chinese Medicine Hospital | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 162 | ITMCTR2100004239 | 2021-01-01 | 2021-01-09 | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Rheumatoid arthritis | control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide;Treatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ; | Yunnan Traditional Chinese Medicine Hospital | NULL | Recruiting | 18 | 65 | Both | control group:31;Treatment group:62; | China | |
| 163 | ChiCTR2100041821 | 2021-01-01 | 2021-01-06 | Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain | Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain | Rheumatoid Arthritis | therapy group:Rebi ointment, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets ;Control group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets; | Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | therapy group:36;Control group:36; | China | |
| 164 | ITMCTR2100004638 | 2021-01-01 | 2021-01-06 | Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain | Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain | Rheumatoid Arthritis | Control group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets;therapy group:Rebi ointment, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets ; | Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Control group:36;therapy group:36; | China | |
| 165 | ChiCTR2100041819 | 2021-01-01 | 2021-01-06 | Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis | Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis | Rheumatoid arthritis | Treatment group:Hanbi ointment + Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;control group:Hanbi ointment simulant+ Methotrexate + Leflunomide Tablets + Folic Acid Tablets ; | The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine | NULL | Recruiting | Both | Treatment group:36;control group:36; | China | |||
| 166 | NCT04755127 (ClinicalTrials.gov) | January 1, 2021 | 27/1/2021 | Arthroscopic Synovectomy of the Wrist in Inflammatory Arthritis | ARthroscopiC SynovecTomy Versus Intra-Articular Injection of Corticosteroids for the Management of Therapy Refractory Psoriatic or Rheumatoid Arthritis of the Wrist: a Randomized Controlled Trial | Wrist Arthritis;Psoriatic Arthritis;Rheumatoid Arthritis;Surgery | Procedure: Arthroscopic synovectomy of the wrist;Drug: Intra-articular corticosteroid injection | Maasstad Hospital | NULL | Recruiting | 18 Years | N/A | All | 80 | N/A | Netherlands |
| 167 | ChiCTR2100041894 | 2021-01-01 | 2021-01-09 | Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain | Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain | Rheumatoid arthritis | therapy group:Yiyisise ointment, Methotrexate, Leflunomide tablets and Folic acid tablets ;Control group:Yiyisise ointment simulant, Methotrexate, Leflunomide tablets and Folic acid tablets; | Yunnan Hospital of Traditional Chinese Medicine | NULL | Recruiting | Both | therapy group:36;Control group:36; | China | |||
| 168 | ITMCTR2100004637 | 2021-01-01 | 2021-01-06 | Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis | Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis | Rheumatoid arthritis | Treatment group:Hanbi ointment + Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;control group:Hanbi ointment simulant+ Methotrexate + Leflunomide Tablets + Folic Acid Tablets ; | The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine | NULL | Recruiting | Both | Treatment group:36;control group:36; | China | |||
| 169 | ITMCTR2000003610 | 2021-01-01 | 2020-08-21 | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | Rheumatoid Arthritis | Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;Experimental group:Duhuo Jisheng Tang, MTX as base treatment.; | Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 70 | Both | Control group:60;Experimental group:60; | China | |
| 170 | ChiCTR2000036094 | 2021-01-01 | 2020-08-21 | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | Rheumatoid Arthritis | Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.; | Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 70 | Both | Experimental group:60;Control group:60; | China | |
| 171 | NCT04535427 (ClinicalTrials.gov) | January 1, 2021 | 22/8/2020 | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: L-arginine;Drug: Placebo | RenJi Hospital | NULL | Not yet recruiting | 18 Years | 45 Years | All | 144 | Phase 2 | China |
| 172 | ChiCTR2000036316 | 2021-01-01 | 2020-08-22 | Effects of dexmedetomidine on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial | Effects of dexmedetomidine on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial | knee osteoarthritis/ knee rheumatoid arthritis | A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine; | West China Hospital, Sichuan University | NULL | Pending | 18 | 80 | Both | A:40;B:40; | China | |
| 173 | ChiCTR2100041777 | 2021-01-01 | 2021-01-05 | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | rheumatoid arthritis | Treatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide; | Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 174 | EUCTR2020-003955-14-DE (EUCTR) | 21/12/2020 | 04/11/2020 | A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy. | Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMT-101 Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Germany | ||
| 175 | EUCTR2018-004558-30-DK (EUCTR) | 18/12/2020 | 05/10/2020 | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 4 | Portugal;Spain;Denmark | ||
| 176 | JPRN-jRCTs071200054 | 17/12/2020 | 18/11/2020 | Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial | Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial | Rheumatoid arthritis | Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 40 | Phase 4 | Japan |
| 177 | NCT04569890 (ClinicalTrials.gov) | December 1, 2020 | 20/9/2020 | Treatment of Pregnancy RA | Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China | Rheumatoid Arthritis;Pregnancy Related | Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone | RenJi Hospital | NULL | Not yet recruiting | 20 Years | 40 Years | Female | 100 | N/A | China |
| 178 | NCT04649697 (ClinicalTrials.gov) | December 1, 2020 | 26/10/2020 | Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients | Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial | Rheumatoid Arthritis | Drug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol Propionate | Cairo University | NULL | Not yet recruiting | 20 Years | 70 Years | All | 39 | Phase 3 | NULL |
| 179 | ChiCTR2200055876 | 2020-12-01 | 2022-01-22 | Efficacy and safety of Iguratimod combined with adalimumab in active rheumatoid arthritis with poor response to csDMARDs | Efficacy and safety of Iguratimod combined with adalimumab in active rheumatoid arthritis with poor response to csDMARDs | Rheumatoid Arthritis | Treatment group:IGU 25mg bid + adalimumab 40mg q2w; | Shandong Provincial Hospital Affiliated to Shandong First Medical University | NULL | Recruiting | 18 | 65 | Both | Treatment group:98; | Phase 4 | China |
| 180 | NCT04292067 (ClinicalTrials.gov) | November 23, 2020 | 26/2/2020 | Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis | Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis | Spondyloarthritis;Rheumatoid Arthritis | Biological: Faecal sampling | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 400 | France | |
| 181 | NCT04758689 (ClinicalTrials.gov) | November 20, 2020 | 11/2/2021 | Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients | Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients | Rheumatoid Arthritis | Combination Product: Laser, exercise, and methotrexate;Combination Product: Exercise, and methotrexate | Cairo University | NULL | Completed | 65 Years | 75 Years | All | 60 | N/A | Egypt |
| 182 | EUCTR2019-000878-30-BE (EUCTR) | 18/11/2020 | 21/09/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Serbia;United States;Philippines;Estonia;Spain;Thailand;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Czechia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan | ||
| 183 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China | ||
| 184 | EUCTR2019-000878-30-LV (EUCTR) | 29/10/2020 | 30/07/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 3000 | Phase 3 | United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 185 | EUCTR2020-000658-83-BG (EUCTR) | 21/10/2020 | 07/10/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Poland;Ukraine;Georgia;Bulgaria | ||
| 186 | NCT04577781 (ClinicalTrials.gov) | October 12, 2020 | 30/9/2020 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 64 Years | All | 28 | Phase 2 | Bulgaria;Georgia;Poland;Ukraine |
| 187 | NCT04470453 (ClinicalTrials.gov) | October 8, 2020 | 9/7/2020 | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug | Rheumatoid Arthritis | Biological: Blood sample;Diagnostic Test: CRQ | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 4 | France |
| 188 | ChiCTR2000036141 | 2020-10-01 | 2020-08-21 | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | Rheumatoid arthritis | 1:Guizhi Decoction+MTX;2:Placebo+MTX; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 75 | Both | 1:76;2:76; | China | |
| 189 | ITMCTR2000003850 | 2020-10-01 | 2020-08-30 | Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1'' | Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1'' | Rheumatoid arthritis | experimental group:Qianghuo Dihuang Decoction + Methotrexate;control group:Methotrexate; | Shanghai Traditional Chinese Medicine Hospital | NULL | Recruiting | Both | experimental group:72;control group:72; | China | |||
| 190 | ChiCTR2000037008 | 2020-10-01 | 2020-08-26 | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | rheumatoid arthritis | experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day; | Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 80 | Both | experimental group:53;control group:53; | China | |
| 191 | ITMCTR2000003615 | 2020-10-01 | 2020-08-21 | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | Rheumatoid arthritis | 2:Placebo+MTX;1:Guizhi Decoction+MTX; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 75 | Both | 2:76;1:76; | China | |
| 192 | NCT04378621 (ClinicalTrials.gov) | October 1, 2020 | 8/4/2020 | Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients | Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Pain;Fatigue;Cognitive Decline;Depression;Brain Diseases;Hand Rheumatism | Drug: TNF-a inhibitor OR JAK inhibitor;Other: Hand training | Vastra Gotaland Region | NULL | Active, not recruiting | 45 Years | 75 Years | All | 212 | N/A | Sweden |
| 193 | ChiCTR2000037675 | 2020-10-01 | 2020-08-30 | Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1'' | Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1'' | Rheumatoid arthritis | control group:Methotrexate;experimental group:Qianghuo Dihuang Decoction + Methotrexate; | Shanghai Traditional Chinese Medicine Hospital | NULL | Recruiting | Both | control group:72;experimental group:72; | China | |||
| 194 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 195 | ITMCTR2000003729 | 2020-10-01 | 2020-08-26 | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | rheumatoid arthritis | experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day; | Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 80 | Both | experimental group:53;control group:53; | China | |
| 196 | EUCTR2019-002810-37-DE (EUCTR) | 23/09/2020 | 20/02/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany | ||
| 197 | NCT04638426 (ClinicalTrials.gov) | September 10, 2020 | 13/11/2020 | Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis | For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa) | Rheumatoid Arthritis | Drug: HL237 tablet;Drug: Placebo of HL237 tablet | Hanlim Pharm. Co., Ltd. | NULL | Enrolling by invitation | 19 Years | N/A | All | 196 | Phase 2 | Korea, Republic of |
| 198 | NCT04255134 (ClinicalTrials.gov) | September 7, 2020 | 14/11/2019 | Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) | Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial | Rheumatoid Arthritis | Drug: Abatacept Injection;Drug: Adalimumab Injection | St George's, University of London | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 4 | United Kingdom |
| 199 | EUCTR2020-002507-19-NL (EUCTR) | 07/09/2020 | 03/09/2020 | Research into administration of lower dosed rituximab with an injection | Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC | rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: rituximab Trade Name: Rixathon Product Name: rituximab | Sint Maartenskliniek | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 4 | Netherlands | ||
| 200 | EUCTR2019-000878-30-BG (EUCTR) | 04/09/2020 | 11/08/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Serbia;United States;Philippines;Estonia;Spain;Thailand;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Czechia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan | ||
| 201 | EUCTR2019-004369-42-CZ (EUCTR) | 01/09/2020 | 05/08/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of | ||
| 202 | NCT04514614 (ClinicalTrials.gov) | September 1, 2020 | 7/8/2020 | Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT | Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT | Arthritis | Drug: 68Ga-FAPI | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 90 Years | All | 100 | Early Phase 1 | China |
| 203 | EUCTR2019-002676-14-SE (EUCTR) | 26/08/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina | ||
| 204 | EUCTR2019-002676-14-BG (EUCTR) | 20/08/2020 | 27/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600 (Ritlecitinib) AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: Ritlecitinib/JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 205 | NCT05214677 (ClinicalTrials.gov) | August 15, 2020 | 12/12/2021 | A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809 | A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809 and DW1809-1 in Healthy Adult Volunteers | Osteoarthritis;Rheumatoid Arthritis;Back Pain;Acute Upper Respiratory Tract Infection | Drug: DW1809;Drug: DW1809-1 | Daewon Pharmaceutical Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 38 | Phase 1 | Korea, Republic of |
| 206 | NCT05214690 (ClinicalTrials.gov) | August 13, 2020 | 12/12/2021 | A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2 | A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers | Osteoarthritis;Rheumatoid Arthritis;Back Pain;Acute Upper Respiratory Tract Infection | Drug: DW1809-T2;Drug: DW1809-1 | Daewon Pharmaceutical Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 37 | Phase 1 | Korea, Republic of |
| 207 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 208 | NCT04512001 (ClinicalTrials.gov) | August 3, 2020 | 11/8/2020 | MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study) | Rheumatoid Arthritis | Drug: MSB11456;Drug: EU-approved RoActemra | Fresenius Kabi SwissBioSim GmbH | NULL | Completed | 18 Years | N/A | All | 604 | Phase 3 | Bulgaria;Czechia;Georgia;Hungary;Moldova, Republic of;Poland;Russian Federation;Serbia;Slovakia |
| 209 | ChiCTR2000035146 | 2020-08-01 | 2020-08-02 | The effect of the IPACK block on pain after primary TKA in different levels of knee flexion deformity patients: a prospective, cohort trial | The effect of the IPACK block on pain after primary TKA in different levels of knee flexion deformity patients: a prospective, cohort trial | knee osteoarthritis/ knee rheumatoid arthritis | The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:Under the guidance of ultrasound, 20 ml 0.25% ropivacaine was injected between popliteal artery and knee joint capsule; | West China Hospital, Sichuan University | NULL | Pending | 18 | 80 | Both | The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:80; | N/A | China |
| 210 | ChiCTR2000035179 | 2020-08-01 | 2020-08-02 | The effect of the iPACK block on pain and knee function in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled triala | The effect of the iPACK block on pain in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled trial | knee osteoarthritis/ knee rheumatoid arthritis | IPACK group:infiltration of 20 ml ropivacaine 0.25% between the interspace between the popliteal artery and capsule of the knee;control group:infiltration of 20ml 0.9% salinebetween the interspace between the popliteal artery and capsule of the knee; | West China Hospital, Sichuan University | NULL | Pending | 18 | 80 | Both | IPACK group:40;control group:40; | N/A | China |
| 211 | NCT04333771 (ClinicalTrials.gov) | July 31, 2020 | 2/4/2020 | A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs. | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | China |
| 212 | NCT04413617 (ClinicalTrials.gov) | July 29, 2020 | 19/5/2020 | TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 460 | Phase 2 | Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine;Bosnia and Herzegovina;Colombia;Sweden |
| 213 | JPRN-jRCTs071190030 | 28/07/2020 | 11/10/2019 | Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments | Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments | Rheumatoid arthritis | Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 80 | Phase 4 | Japan |
| 214 | EUCTR2019-002676-14-SK (EUCTR) | 27/07/2020 | 27/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz® 11mg Prolonged Release Tablet INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 215 | ChiCTR2100050865 | 2020-07-18 | 2021-09-05 | Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritis | A multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis | rheumatoid arthritis | Group 1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody;Group 2:Methotrexate tablets + Adamu monoclonal antibody; | The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 80 | Both | Group 1:30;Group 2:30; | Phase 4 | China |
| 216 | ITMCTR2100005277 | 2020-07-18 | 2021-09-05 | Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritis | A multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis | rheumatoid arthritis | 1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody;2:Methotrexate tablets + Adamu monoclonal antibody ; | The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 80 | Both | 1:30;2:30; | Phase 4 | China |
| 217 | NCT04324892 (ClinicalTrials.gov) | July 12, 2020 | 25/3/2020 | Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study | Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study | Rheumatoid Arthritis | Drug: Treat to target | Chinese University of Hong Kong | NULL | Not yet recruiting | 18 Years | N/A | All | 110 | NULL | |
| 218 | EUCTR2019-002676-14-CZ (EUCTR) | 07/07/2020 | 11/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB), AND TOFACITINIB ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina | ||
| 219 | NCT04428424 (ClinicalTrials.gov) | July 5, 2020 | 10/6/2020 | Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients | The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept | Arthritis, Rheumatoid | Drug: Enbrel | Pfizer | NULL | Completed | 18 Years | N/A | All | 1 | Iraq | |
| 220 | JPRN-UMIN000040094 | 2020/07/01 | 01/07/2020 | Development of chronotherapeutics in rheumatoid arthritis | Development of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis | rheumatoid arthritis | baricitinib 4mg morning baricitinib 4mg evening baricitinib 2mg evening baricitinib 2mg morning | Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine | NULL | Recruiting | 18years-old | 100years-old | Male and Female | 120 | Not applicable | Japan |
| 221 | JPRN-jRCTs071190046 | 29/06/2020 | 20/02/2020 | Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial | Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial | Rheumatoid arthritis | Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS MA from enbrel. In addition, for patients receiving etanercept BS MA 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS MA 25 mg weekly to test whether LDA/remission persists until week 52. | Kawakami Atsushi | NULL | Not Recruiting | >= 20age old | Not applicable | Both | 62 | Phase 4 | Japan |
| 222 | NCT04163016 (ClinicalTrials.gov) | June 19, 2020 | 24/10/2019 | A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis | Drug: Pharmacokinetics of certolizumab pegol | UCB Biopharma S.P.R.L. | NULL | Active, not recruiting | 18 Years | N/A | Female | 22 | Phase 1 | United States;France;Germany;Spain;Switzerland;Canada;Netherlands |
| 223 | EUCTR2019-002676-14-HU (EUCTR) | 18/06/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 224 | EUCTR2019-002810-37-PL (EUCTR) | 16/06/2020 | 11/03/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany | ||
| 225 | EUCTR2019-002810-37-BG (EUCTR) | 15/06/2020 | 28/04/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Germany | ||
| 226 | NCT04584541 (ClinicalTrials.gov) | June 11, 2020 | 10/6/2020 | SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism | Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments | Spondyloarthritis;Rheumatoid Arthritis;Covid19 | Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | 18 Years | N/A | All | 150 | N/A | France |
| 227 | ChiCTR2000033214 | 2020-06-01 | 2020-05-24 | Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis | Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis | Rheumatoid Arthritis | Group 1:Tofacitinib;Group 2:cDMARDs; | Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University | NULL | Pending | 18 | Both | Group 1:52;Group 2:52; | Phase 4 | NULL | |
| 228 | ChiCTR2000033004 | 2020-06-01 | 2020-05-17 | Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis | Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis | Rheumatoid arthritis | Group 1:glucocorticoid;Group 2:intravenous lidocaine infusion and glucocorticoid;Group 3:intravenous lidocaine infusion;Group 4:NSAIDS; | Department of Pain, Guizhou Provincial People's Hospita | NULL | Pending | 18 | 65 | Both | Group 1:30;Group 2:30;Group 3:30;Group 4:30; | China | |
| 229 | EUCTR2019-001185-15-BG (EUCTR) | 29/05/2020 | 15/05/2020 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 230 | EUCTR2019-004369-42-BG (EUCTR) | 28/05/2020 | 07/05/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Germany;Moldova, Republic of | ||
| 231 | EUCTR2018-003418-41-GB (EUCTR) | 18/05/2020 | 22/11/2019 | A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint. | A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA) | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Lymphoseek Product Name: technetium Tc 99m tilmanocept INN or Proposed INN: not applicable Other descriptive name: TILMANOCEPT | Navidea Biopharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;European Union;United Kingdom | ||
| 232 | EUCTR2019-004369-42-SK (EUCTR) | 12/05/2020 | 09/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of | ||
| 233 | EUCTR2019-004078-24-ES (EUCTR) | 07/05/2020 | 21/02/2020 | Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis | Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET | RHEUMATOID ARTHRITIS MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: KEVZARA INN or Proposed INN: SARILUMAB | IDIVAL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Spain | ||
| 234 | EUCTR2019-004369-42-PL (EUCTR) | 05/05/2020 | 23/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of | ||
| 235 | EUCTR2019-002205-22-BE (EUCTR) | 05/05/2020 | 21/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 236 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 237 | NCT05665985 (ClinicalTrials.gov) | May 1, 2020 | 26/11/2022 | Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients | Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Moringa Oleifera | Universitas Sebelas Maret | NULL | Completed | 18 Years | 60 Years | Female | 30 | Phase 1/Phase 2 | Indonesia |
| 238 | NCT04350216 (ClinicalTrials.gov) | April 30, 2020 | 8/4/2020 | Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET) | Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Atherosclerosis | Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] | Instituto de Investigación Marqués de Valdecilla | NULL | Not yet recruiting | 18 Years | 100 Years | All | 20 | Phase 4 | NULL |
| 239 | EUCTR2019-004369-42-HU (EUCTR) | 27/04/2020 | 03/03/2020 | A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I) | A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I | Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Fresenius Kabi SwissBioSim GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of | ||
| 240 | EUCTR2019-002810-37-LT (EUCTR) | 17/04/2020 | 03/03/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany | ||
| 241 | NCT04361513 (ClinicalTrials.gov) | April 15, 2020 | 22/4/2020 | Genicular Nerve Block in Rheuamtoid Arthritis | Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial | Pain;Joint Function Disorder;Inflammation | Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer);Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) | Sohag University | NULL | Completed | 18 Years | N/A | All | 64 | Phase 4 | Egypt |
| 242 | EUCTR2019-000867-26-DE (EUCTR) | 08/04/2020 | 04/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 243 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 244 | JPRN-UMIN000040054 | 2020/04/06 | 04/04/2020 | The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block | The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block - The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block | knee osteoarthritis or knee rheumatoid arthritis | Popliteal Plexus Block with 0.25% levobupivacaine 10 mL Tibial Nerve Block(TNB) with 0.25% levobupivacaine 10 mL | Daiyukai General Hospital | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 120 | Phase 3 | Japan |
| 245 | ChiCTR1900026270 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 246 | ITMCTR1900002628 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 247 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom | ||
| 248 | EUCTR2019-000878-30-HU (EUCTR) | 26/03/2020 | 28/02/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany | ||
| 249 | NCT04434118 (ClinicalTrials.gov) | March 20, 2020 | 13/6/2020 | Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients | Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study | Rheumatoid Arthritis;COVID | Drug: Traditional antirheumatic drugs | Sadat City University | NULL | Withdrawn | 18 Years | 60 Years | All | 0 | Egypt | |
| 250 | NCT04247815 (ClinicalTrials.gov) | March 16, 2020 | 16/1/2020 | Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA | A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ATI-450;Drug: Placebo oral tablet;Drug: Methotrexate | Aclaris Therapeutics, Inc. | NULL | Completed | 18 Years | 70 Years | All | 19 | Phase 2 | United States |
| 251 | NCT04389320 (ClinicalTrials.gov) | March 15, 2020 | 11/5/2020 | Antimalarial and Covid 19 in Rheumatoid Arthritis | Antimalarial and Covid 19 in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hydroxychloroquine | Assiut University | NULL | Completed | 20 Years | 70 Years | All | 60 | Egypt | |
| 252 | EUCTR2019-000868-18-DE (EUCTR) | 13/03/2020 | 08/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 253 | EUCTR2019-003700-12-FR (EUCTR) | 13/03/2020 | 04/06/2020 | Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients | Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug | rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | France | ||
| 254 | EUCTR2019-002810-37-HU (EUCTR) | 09/03/2020 | 20/01/2020 | A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera® | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB | Dr. Reddy’s Laboratories S.A. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Estonia;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany | ||
| 255 | JPRN-jRCT1041190125 | 09/03/2020 | 09/03/2020 | PRECIOUS-B study | Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study | Rheumatoid arthritis | 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Asai Shuji | NULL | Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 256 | NCT03559686 (ClinicalTrials.gov) | March 2, 2020 | 5/6/2018 | Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA) | Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051 | Rheumatoid Arthritis | Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | NULL | Available | 18 Years | N/A | All | NULL | ||
| 257 | ChiCTR2000030400 | 2020-03-01 | 2020-03-01 | Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia | Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia | Interstitial pneumonia | Case series:Tetrandrine; | The First People's Hospital of Yancheng | NULL | Recruiting | 36 | 78 | Both | Case series:41; | China | |
| 258 | NCT04928066 (ClinicalTrials.gov) | March 1, 2020 | 9/6/2021 | The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA | Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: Tofacitinib;Drug: Pred | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 4 | China |
| 259 | ITMCTR2000003055 | 2020-03-01 | 2020-02-26 | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Systemic lupus erythematosus | experimental group:Integrative MTX with Guanxinning;control group:MTX; | Zhejinag University of f Chinese Medicine | NULL | Recruiting | Both | experimental group:30;control group:30; | China | |||
| 260 | ChiCTR2000030247 | 2020-03-01 | 2020-02-26 | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Systemic lupus erythematosus | experimental group:Integrative MTX with Guanxinning;control group:MTX; | Zhejinag University of f Chinese Medicine | NULL | Recruiting | Both | experimental group:30;control group:30; | China | |||
| 261 | EUCTR2019-000878-30-CZ (EUCTR) | 26/02/2020 | 06/01/2020 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Serbia;United States;Philippines;Estonia;Spain;Thailand;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Czechia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan | ||
| 262 | EUCTR2018-003351-37-FR (EUCTR) | 19/02/2020 | 28/05/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;France;Australia;Lithuania;Germany | ||
| 263 | EUCTR2019-001185-15-NO (EUCTR) | 19/02/2020 | 07/11/2019 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 264 | EUCTR2019-000878-30-LT (EUCTR) | 13/02/2020 | 25/11/2019 | A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Serbia;United States;Philippines;Estonia;Spain;Thailand;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Czechia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan | ||
| 265 | EUCTR2019-004468-23-GB (EUCTR) | 10/02/2020 | 26/02/2020 | Biologics for RA Pain ( BIORA-PAIN) | Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Abatacept Product Name: Abatacept INN or Proposed INN: Abatacept Trade Name: Humira Product Name: Humira INN or Proposed INN: Humira | St George's, University of London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | United Kingdom | ||
| 266 | EUCTR2018-004558-30-PT (EUCTR) | 03/02/2020 | 21/05/2019 | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 4 | Portugal;Spain | ||
| 267 | EUCTR2019-000284-24-CZ (EUCTR) | 03/02/2020 | 17/10/2019 | A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis. | A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. | Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 4 | United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina | ||
| 268 | NCT04779892 (ClinicalTrials.gov) | February 1, 2020 | 26/2/2021 | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | Rheumatoid Arthritis | Drug: Infliximab | Taizhou Mabtech Pharmaceutical Co.,Ltd | NULL | Completed | 18 Years | 45 Years | Male | 90 | Phase 1 | China |
| 269 | EUCTR2018-004429-94-NL (EUCTR) | 21/01/2020 | 17/06/2019 | Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan. | [18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: [18F]PEG-Folate | VU Medical Center, department of Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 4 | Netherlands | ||
| 270 | EUCTR2019-004101-27-NL (EUCTR) | 15/01/2020 | 12/12/2019 | Research into injecting golimumab less frequently by using increased doses | INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO | rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sint Maartenskliniek | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 271 | JPRN-UMIN000039116 | 2020/01/15 | 15/01/2020 | Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. | Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. - SMAPP | Osteoarthritis, Rheumatoid arthritis | Administration of zolpidem tartrate of 5mg for 7 days after surgery No administration of zolpidem tartrate | Mito medical center, Mito Kyodo General Hospital, University of Tsukuba | NULL | Pending | 20years-old | Not applicable | Male and Female | 84 | Not selected | Japan |
| 272 | NCT04230213 (ClinicalTrials.gov) | January 13, 2020 | 14/1/2020 | A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis | A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis | Drug: PF-06410293;Drug: adalimumab | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 455 | Phase 3 | United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine |
| 273 | EUCTR2019-004179-38-SE (EUCTR) | 10/01/2020 | 19/11/2019 | Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis | Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA | Patients with early active rheumatoid arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Trade Name: Metotrexat Orion | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Sweden | ||
| 274 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 275 | JPRN-UMIN000042632 | 2020/01/01 | 03/12/2020 | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis | Rheumatoid arthritis | low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients | Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 34 | Not applicable | Asia(except Japan) |
| 276 | NCT04115397 (ClinicalTrials.gov) | January 2020 | 2/10/2019 | Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints | Towards Efficient Prediction and Prevention of Rheumatoid Arthritis | Seropositive Muskuloskeletal Complaints | Drug: Zoledronic Acid;Drug: Placebo | Karolinska Institutet | NULL | Not yet recruiting | 18 Years | N/A | All | 80 | Phase 4 | NULL |
| 277 | EUCTR2019-000797-39-IT (EUCTR) | 20/12/2019 | 24/05/2021 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severelyactive rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Tofacitinib Product Code: [Tofacitinib] INN or Proposed INN: Tofacitinib citrate Product Name: GSK3196165 Product Code: [GSK3196165] INN or Proposed INN: Otilimab | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;Sweden | ||
| 278 | EUCTR2019-000868-18-IT (EUCTR) | 18/12/2019 | 17/06/2021 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 20.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: N/A Product Name: Otilimab Product Code: [GSK3196165] INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab Product Code: [N/A] INN or Proposed INN: Sarilumab Trade Name: NA Product Name: Otilimab Product Code: [GSK3196165] Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: NA Product Name: Otilimab Product Code: [GSK3196165] Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 279 | EUCTR2019-000284-24-LT (EUCTR) | 18/12/2019 | 07/11/2019 | A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis. | A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. | Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina | ||
| 280 | NCT04046146 (ClinicalTrials.gov) | December 15, 2019 | 23/7/2019 | Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport | Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport | Rheumatoid Arthritis | Drug: Indocyanine Green;Device: MultiSpectral Imaging System | University of Rochester | NULL | Completed | 18 Years | 89 Years | All | 2 | Phase 1 | United States |
| 281 | EUCTR2018-003351-37-LT (EUCTR) | 13/12/2019 | 29/08/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 282 | EUCTR2019-000867-26-GB (EUCTR) | 10/12/2019 | 12/06/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 283 | NCT04163991 (ClinicalTrials.gov) | December 9, 2019 | 12/11/2019 | A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: VIB4920;Drug: Placebo | Viela Bio | NULL | Completed | 18 Years | 99 Years | All | 78 | Phase 2 | United States;Poland |
| 284 | EUCTR2019-000868-18-GB (EUCTR) | 02/12/2019 | 11/06/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Kevzara INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colo | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 285 | ChiCTR1900027855 | 2019-11-29 | 2019-11-30 | Pharmacokinetics of CYP2C9 * 3 homozygous mutant subjects in a single oral meloxicam tablet | Pharmacokinetics of CYP2C9 * 3 homozygous mutant subjects in a single oral meloxicam tablet | Osteoarthritis, rheumatoid arthritis | Case:Meloxicam 15mg; | Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University | NULL | Pending | 18 | 45 | Male | Case:1; | Phase 1 | China |
| 286 | EUCTR2019-001754-25-NL (EUCTR) | 25/11/2019 | 25/11/2019 | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch) | rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 4 | Netherlands | ||
| 287 | NCT04136262 (ClinicalTrials.gov) | November 25, 2019 | 21/10/2019 | Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis | Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF) | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Recruiting | N/A | N/A | Female | 300 | Phase 2/Phase 3 | China |
| 288 | EUCTR2019-000797-39-GB (EUCTR) | 22/11/2019 | 10/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation | ||
| 289 | EUCTR2018-004287-56-FR (EUCTR) | 21/11/2019 | 31/01/2020 | Methotrexate and Metformin in rheumatoid arthritis patients | Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 | rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METFORMINE ARROW 500mg Product Name: Metformin Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Acide folique Product Name: Acide folique Product Code: B03BB01 Trade Name: Prednisone Product Name: Prednisone Product Code: H02AB07 | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 290 | NCT04227366 (ClinicalTrials.gov) | November 19, 2019 | 25/12/2019 | Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: BCD-089;Biological: Placebo;Drug: Methotrexat | Biocad | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | Russian Federation |
| 291 | EUCTR2019-000797-39-PL (EUCTR) | 18/11/2019 | 15/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anit human granulocyt-macrophage colony-stimulating factor (GM-CSF)monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF)monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 292 | EUCTR2019-000868-18-PL (EUCTR) | 15/11/2019 | 11/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Antihuman granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 293 | EUCTR2019-000867-26-PL (EUCTR) | 15/11/2019 | 15/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 294 | EUCTR2019-000867-26-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 295 | EUCTR2019-000868-18-ES (EUCTR) | 14/11/2019 | 26/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 296 | EUCTR2019-000797-39-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 297 | NCT04038970 (ClinicalTrials.gov) | November 8, 2019 | 29/7/2019 | Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate | Rheumatoid Arthritis | Biological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: Methotrexate | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | NULL | Completed | 18 Years | N/A | All | 145 | Phase 2 | China |
| 298 | EUCTR2019-001185-15-SE (EUCTR) | 06/11/2019 | 01/07/2019 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 299 | EUCTR2019-001793-28-NL (EUCTR) | 05/11/2019 | 05/11/2019 | Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW) | Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi Product Name: Adalimumab Product Code: D2E7 INN or Proposed INN: ADALIMUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 89 | Phase 4 | Netherlands | ||
| 300 | NCT04170504 (ClinicalTrials.gov) | November 2019 | 14/11/2019 | Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis | Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX) | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Not yet recruiting | 18 Years | N/A | All | 204 | Phase 2/Phase 3 | NULL |
| 301 | EUCTR2019-001554-25-NL (EUCTR) | 29/10/2019 | 29/10/2019 | Adalimumab dose optimization in rheumatoid arthritis using drugconcentration in blood (ADDORA): multi-center open label randomizedcontrolled trail | Adalimumab dose optimization in rheumatoid arthritis using therapeuticdrug monitoring (ADDORA): multi-center open label randomized controlledtrail - ADalimumab Dose Optimization in Rheumatoid Arthritis using (ADDORA) | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi Product Name: Adalimumab Product Code: D2E7 INN or Proposed INN: ADALIMUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 1;Phase 4 | Netherlands | ||
| 302 | EUCTR2019-000867-26-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 303 | EUCTR2019-000868-18-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 304 | NCT04049448 (ClinicalTrials.gov) | October 24, 2019 | 6/8/2019 | Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis | A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ABX464 | Abivax S.A. | NULL | Completed | 18 Years | 76 Years | All | 40 | Phase 2 | Belgium;Czechia;France;Hungary;Poland |
| 305 | EUCTR2019-000797-39-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China | ||
| 306 | EUCTR2019-001578-27-HU (EUCTR) | 15/10/2019 | 02/09/2019 | Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Hungary | ||
| 307 | NCT04130178 (ClinicalTrials.gov) | October 15, 2019 | 11/10/2019 | Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study | Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study | Rheumatoid Arthritis | Drug: Nerve block | Sohag University | NULL | Completed | 18 Years | N/A | All | 48 | N/A | Egypt |
| 308 | EUCTR2019-000797-39-LT (EUCTR) | 11/10/2019 | 19/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 309 | EUCTR2019-000867-26-BG (EUCTR) | 11/10/2019 | 30/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 310 | EUCTR2019-000868-18-LT (EUCTR) | 11/10/2019 | 19/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;Italy;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 311 | EUCTR2019-000867-26-EE (EUCTR) | 10/10/2019 | 01/08/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 312 | NCT04120831 (ClinicalTrials.gov) | October 7, 2019 | 4/10/2019 | TOLERA: Tolerance Enhancement in RA | Sequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing Methotrexate | Rheumatoid Arthritis | Drug: Abatacept Injection | University of Erlangen-Nürnberg Medical School | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Germany |
| 313 | EUCTR2018-003351-37-HU (EUCTR) | 07/10/2019 | 24/07/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 314 | EUCTR2017-003037-28-NL (EUCTR) | 02/10/2019 | 22/07/2019 | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA | RA patients with active RA despite treatment with DMARDs. MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE INN or Proposed INN: PREDNISOLONE Other descriptive name: Prednisolone | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 315 | NCT04273334 (ClinicalTrials.gov) | October 1, 2019 | 15/2/2020 | Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders | Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc. | Lymphatic Disorders | Drug: 68Ga-NEB | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 90 | Phase 1 | China |
| 316 | NCT03194204 (ClinicalTrials.gov) | October 1, 2019 | 10/6/2017 | Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial | Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Doxycycline Tablets | Assiut University | NULL | Completed | 18 Years | 60 Years | All | 160 | N/A | Egypt |
| 317 | JPRN-JapicCTI-194932 | 01/10/2019 | 28/08/2019 | An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis | An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : ozoralizumab INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Taisho Pharmaceutical Co.Ltd | NULL | complete | 20 | BOTH | 505 | Phase 3 | Japan | |
| 318 | NCT04077567 (ClinicalTrials.gov) | October 1, 2019 | 29/8/2019 | An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis | An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TS-152 | Taisho Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 20 Years | N/A | All | 401 | Phase 3 | Japan |
| 319 | ITMCTR1900002626 | 2019-09-28 | 2019-09-28 | A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue | Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial | Rheumatoid arthritis (RA);FA20 | High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ; | Zhejiang Provincal Hospital of TCM | NULL | Pending | 18 | 70 | Both | High-dose experimental group :30;Low-dose experimental group:30;Control group :30; | Phase 2 | China |
| 320 | ChiCTR1900026257 | 2019-09-28 | 2019-09-28 | A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue | Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial | Rheumatoid arthritis (RA) | High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ; | Zhejiang Provincal Hospital of TCM | NULL | Pending | 18 | 70 | Both | High-dose experimental group :30;Low-dose experimental group:30;Control group :30; | Phase 2 | China |
| 321 | EUCTR2019-000868-18-CZ (EUCTR) | 20/09/2019 | 20/08/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Argentina;Hungary;United States;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Belgium;China;Korea, Republic of;Poland;Italy;South Africa;Lithuania;Germany | ||
| 322 | EUCTR2019-000797-39-CZ (EUCTR) | 19/09/2019 | 18/09/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 323 | EUCTR2018-004677-27-BE (EUCTR) | 16/09/2019 | 25/03/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 324 | EUCTR2018-003351-37-GR (EUCTR) | 13/09/2019 | 29/07/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands | ||
| 325 | EUCTR2019-000797-39-LV (EUCTR) | 13/09/2019 | 25/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 326 | NCT04472481 (ClinicalTrials.gov) | September 6, 2019 | 7/7/2020 | Vitamin D Effect in Rheumatoid Arthritis. | Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients. | Active Rheumatoid Arthritis | Drug: Ergocalciferol 1.25 mg tablet | Tanta University | NULL | Completed | 33 Years | 60 Years | All | 20 | Phase 4 | Egypt |
| 327 | EUCTR2018-003351-37-ES (EUCTR) | 05/09/2019 | 16/09/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Lilly S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 328 | EUCTR2018-003351-37-PL (EUCTR) | 04/09/2019 | 09/08/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 329 | NCT03971253 (ClinicalTrials.gov) | September 2, 2019 | 30/5/2019 | Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis | Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Drug: Peficitinib | Astellas Pharma Inc | NULL | Recruiting | N/A | N/A | All | 3000 | Japan | |
| 330 | ChiCTR2200057200 | 2019-09-01 | 2022-03-03 | Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: A randomized, controlled trial | Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: A randomized, controlled trial | Rheumatoid arthritis, etc. | group PCIA :2ug/kg+ dezocine 20mg+ dolasetron 25mg, diluted to 100mL by adding normal saline, no loading volume was set, background infusion rate was set as 2mL/h, and blous volume was 0.5ml/ time;group PCEA :0.1% ropivacaine, load set at 10mL, background infusion rate of 5mL/h, locking time of 20min, blous dose of 5ml/ time;group CFNBA :0.1% ropivacaine, loading volume 10ml, background infusion rate 5ml/h, locking time 20min, blous volume 5ml/ time; | Quanzhou First Hospital Affiliated to Fujian Medical University | NULL | Completed | 60 | Both | group PCIA :20;group PCEA :20;group CFNBA :20; | China | ||
| 331 | EUCTR2018-003351-37-NL (EUCTR) | 29/08/2019 | 08/07/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands | ||
| 332 | EUCTR2018-003351-37-DK (EUCTR) | 29/08/2019 | 07/08/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;Australia;France;Lithuania;Germany | ||
| 333 | JPRN-JapicCTI-194928 | 26/8/2019 | 22/08/2019 | -An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 | An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 | Rheumatoid Arthritis | Intervention name : methotrexate INN of the intervention : methotrexate Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg. Control intervention name : methotrexate INN of the control intervention : methotrexate Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval. | medac GmbH | NULL | complete | 20 | 75 | BOTH | 100 | Phase 3 | Japan |
| 334 | NCT04004429 (ClinicalTrials.gov) | August 26, 2019 | 26/6/2019 | A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease | A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease | Rheumatoid Arthritis | Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo | SynAct Pharma Aps | NULL | Completed | 18 Years | 85 Years | All | 105 | Phase 2 | Denmark;Norway |
| 335 | EUCTR2018-003351-37-IT (EUCTR) | 20/08/2019 | 15/06/2021 | Uno studio di fase 3b/4 sull'Artrite Reumatoide | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel Product Code: [Enbrel] INN or Proposed INN: ETANERCEPT Trade Name: Humira Product Name: Humira Product Code: [Humira] INN or Proposed INN: ADALIMUMAB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 336 | NCT04179513 (ClinicalTrials.gov) | August 15, 2019 | 25/11/2019 | A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients | Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups | Rheumatoid Arthritis | Biological: GB224 10mg;Biological: GB224 20mg | Genor Biopharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 24 | Phase 1 | China |
| 337 | EUCTR2018-003351-37-AT (EUCTR) | 13/08/2019 | 31/07/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 338 | ChiCTR1900025013 | 2019-08-08 | 2019-08-07 | Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty | Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis | Total knee arthroplasty | group 1:Intravenous infusion of 1g of tranexamic acid at 3 hours after surgery ;group 2:Intravenous infusion of 1g of tranexamic acid at 3, 6, and 12 hours after surgery; | Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 50 | 75 | Both | group 1:52;group 2:52; | Phase 4 | China |
| 339 | ITMCTR1900002510 | 2019-08-08 | 2019-08-07 | Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty | Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis | Total knee arthroplasty | group 1:Intravenous infusion of 1g of tranexamic acid + 100 ml 3 hours after surgery, intravenous infusion of 100 ml of normal saline 6 and 12 hours after surgery.;group 2:Intravenous infusion of 1g of tranexamic acid + 100 ml of normal saline at 3, 6, and 12 hours after surgery; | Guanghua Hospital, Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 50 | 75 | Both | group 1:38;group 2:38; | Phase 4 | China |
| 340 | EUCTR2018-003351-37-GB (EUCTR) | 08/08/2019 | 16/05/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany | ||
| 341 | EUCTR2018-004605-57-NL (EUCTR) | 06/08/2019 | 24/07/2019 | Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients | Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA) | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 342 | EUCTR2018-003351-37-DE (EUCTR) | 02/08/2019 | 24/07/2019 | A Phase 3b/4 Study in Rheumatoid Arthritis | A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2600 | Phase 3;Phase 4 | United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Poland;Romania;Denmark;Australia;South Africa;Germany;Netherlands | ||
| 343 | ITMCTR1900002503 | 2019-08-01 | 2019-08-03 | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | Rheumatoid Arthritis | Positive control group:Methotrexate;Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang); | The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Positive control group:50;Experimental group:50; | N/A | China |
| 344 | NCT04068246 (ClinicalTrials.gov) | August 1, 2019 | 21/8/2019 | The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients | The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. | Rheumatoid Arthritis | Drug: Metformin;Drug: Placebo | Sadat City University | NULL | Completed | 18 Years | N/A | All | 120 | Phase 1/Phase 2 | Egypt |
| 345 | ChiCTR1900024902 | 2019-08-01 | 2019-08-03 | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis | Rheumatoid Arthritis | Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate; | The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Experimental group:50;Positive control group:50; | N/A | China |
| 346 | NCT02418273 (ClinicalTrials.gov) | August 1, 2019 | 6/4/2015 | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study | Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis | Drug: denosumab | Indiana University | NULL | Withdrawn | 4 Years | 16 Years | All | 0 | Phase 1/Phase 2 | United States |
| 347 | EUCTR2018-004677-27-HU (EUCTR) | 25/07/2019 | 25/07/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 348 | ChiCTR1900025021 | 2019-07-25 | 2019-08-07 | Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects | Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects | Osteoarthritis, rheumatoid arthritis | A:TR group: phase I: Meloxicam Suspension Injection (T) 7.5 mg, phase II: Mobi (R) 7.5 mg; RT group: phase I: R, phase II: T.;B:Meloxicam Suspension Injection 15 mg;C:Meloxicam Suspension Injection 30 mg;D:Meloxicam Suspension Injection 60 mg; | Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University | NULL | Recruiting | Both | A:12;B:12;C:12;D:12; | Phase 1 | China | ||
| 349 | EUCTR2018-003933-14-BE (EUCTR) | 19/07/2019 | 24/04/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 350 | EUCTR2018-003330-32-PL (EUCTR) | 19/07/2019 | 06/05/2019 | Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies | Rheumatoid Arthritis Despite Treatment With Conventional Therapies MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cevidoplenib Product Code: SKI-O-703 INN or Proposed INN: Cevidoplenib | Oscotec Inc. | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2 | United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of | ||
| 351 | ChiCTR1900024261 | 2019-07-15 | 2019-07-03 | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | rheumatoid arthritis | A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week); | The Second Hospital of Shanxi Medical University | NULL | Pending | 18 | 65 | Both | A:30;B:30; | Phase 4 | China |
| 352 | EUCTR2016-003682-26-PL (EUCTR) | 11/07/2019 | 17/05/2018 | Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis | A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis | Early Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: METHOTREXATE Product Code: METHOTREXATE INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Can-Fite BioPharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 353 | NCT04464642 (ClinicalTrials.gov) | July 10, 2019 | 6/7/2020 | Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis | Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Tofacitinib | Dr. Mohammad Mamun Khan | NULL | Active, not recruiting | 18 Years | N/A | All | 110 | Phase 4 | Bangladesh |
| 354 | EUCTR2019-000660-25-PL (EUCTR) | 09/07/2019 | 20/05/2019 | Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CT-P17 Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Poland | ||
| 355 | NCT03813199 (ClinicalTrials.gov) | July 4, 2019 | 15/1/2019 | Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis | Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfa, or Intolerance to Anti-Tnfa | Rheumatoid Arthritis | Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate | Abivax S.A. | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | Belgium;Czechia;France;Hungary;Poland |
| 356 | JPRN-UMIN000037359 | 2019/07/01 | 13/07/2019 | Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty | Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty - Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty | knee osteoarthritis or knee rheumatoid arthritis | Group ACB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the apex of femoral triangle Group FTB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the midthigh level (midpoint between anterior superior iliac spine and upper edge of patella) | Daiyukai General Hospital | NULL | Complete: follow-up continuing | 20years-old | 100years-old | Male and Female | 120 | Phase 3 | Japan |
| 357 | NCT04188249 (ClinicalTrials.gov) | July 1, 2019 | 27/6/2019 | Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis | A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Golimumab | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 200 | China | |
| 358 | ChiCTR2000039799 | 2019-07-01 | 2020-11-10 | Reduction or discontinuation of tofacitinib in patients with rheumatoid arthritis after low disease activity: a multicenter, prospective study | Reduction or discontinuation of tofacitinib in patients with rheumatoid arthritis after low disease activity: a multicenter, prospective study | Rheumatoid Arthritis | A:Keep the dose of tofacitinib unchanged;B:Reduce the dose of tofacitinib to 5mg qd;C:Stop using tofacitinib; | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 | 70 | Both | A:42;B:42;C:42; | Phase 4 | China |
| 359 | EUCTR2018-003053-21-PL (EUCTR) | 27/06/2019 | 16/04/2019 | A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ABBV-3373 INN or Proposed INN: ABBV-3373 Trade Name: Humira (adalimumab) Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Puerto Rico;Poland;Israel | ||
| 360 | EUCTR2018-003933-14-BG (EUCTR) | 21/06/2019 | 27/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 361 | NCT03912428 (ClinicalTrials.gov) | June 14, 2019 | 10/4/2019 | Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis | Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis | Myositis;Inflammatory;Rheumatoid Arthritis;Healthy Volunteers | Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176 | National Institute of Mental Health (NIMH) | NULL | Recruiting | 18 Years | 99 Years | All | 96 | Phase 1 | United States |
| 362 | EUCTR2018-003877-91-DE (EUCTR) | 13/06/2019 | 26/02/2019 | B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy | Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA | Active rheumatoid arthritis with ACPA antibodies failing methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | INN or Proposed INN: RITUXIMAB Trade Name: Orencia INN or Proposed INN: ABATACEPT | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Germany | ||
| 363 | EUCTR2019-001185-15-DK (EUCTR) | 06/06/2019 | 12/04/2019 | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 364 | EUCTR2018-004539-54-DE (EUCTR) | 03/06/2019 | 10/04/2019 | Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy | Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte | Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex | Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 4 | Germany | ||
| 365 | NCT04344405 (ClinicalTrials.gov) | June 1, 2019 | 9/4/2020 | Vitamin D as a Key Player in Rheumatoid Arthritis | Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response | the Immunomodulatory Effect | Drug: Vitamin D;Drug: Steroid Drug | Assiut University | NULL | Completed | 20 Years | 70 Years | All | 40 | Phase 3 | Egypt |
| 366 | NCT04033809 (ClinicalTrials.gov) | May 30, 2019 | 16/7/2019 | Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients | Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial | Rheumatoid Arthritis | Dietary Supplement: Multigrain powder (S) | Universiti Sains Malaysia | NULL | Completed | 21 Years | N/A | All | 54 | N/A | Malaysia |
| 367 | EUCTR2018-003933-14-CZ (EUCTR) | 28/05/2019 | 29/04/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 368 | EUCTR2018-003933-14-LV (EUCTR) | 27/05/2019 | 07/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 369 | EUCTR2018-004558-30-ES (EUCTR) | 16/05/2019 | 11/04/2019 | Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response. | Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response. | rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 370 | ChiCTR2000032534 | 2019-05-15 | 2020-05-01 | Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study | Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study | Rheumatoid arthritis | Experimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine; | The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU. | NULL | Completed | Both | Experimental group:47;Control group:43; | Phase 4 | China | ||
| 371 | EUCTR2018-002306-31-GB (EUCTR) | 15/05/2019 | 14/02/2019 | A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom | ||
| 372 | NCT03589833 (ClinicalTrials.gov) | May 14, 2019 | 5/7/2018 | Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA | Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: Yisaipu | Peking Union Medical College Hospital | NULL | Completed | 18 Years | 65 Years | All | 504 | Phase 4 | China |
| 373 | NCT03823378 (ClinicalTrials.gov) | May 13, 2019 | 8/1/2019 | A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599) | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo;Drug: ABBV-105 | AbbVie | NULL | Completed | 18 Years | N/A | All | 97 | Phase 2 | Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom |
| 374 | EUCTR2019-000505-72-NL (EUCTR) | 13/05/2019 | 18/02/2019 | Baricitinib in patients suffering from Rheumatoid Arthritis | Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT) | Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: baricitinib | Transparency in Healthcare | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 375 | EUCTR2018-002306-31-BE (EUCTR) | 30/04/2019 | 07/02/2019 | A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom | ||
| 376 | EUCTR2018-003933-14-ES (EUCTR) | 30/04/2019 | 21/05/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 377 | EUCTR2018-003933-14-EE (EUCTR) | 09/04/2019 | 14/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia | ||
| 378 | NCT03938636 (ClinicalTrials.gov) | April 8, 2019 | 24/4/2019 | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging | Rheumatoid Arthritis | Drug: TC99m-tilmanocept | Navidea Biopharmaceuticals | NULL | Completed | 18 Years | N/A | All | 95 | Phase 2 | United States |
| 379 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Procedure: Biospecimen Collection;Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 1 | United States;Canada |
| 380 | EUCTR2018-002306-31-ES (EUCTR) | 04/04/2019 | 12/04/2019 | A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 381 | NCT03669367 (ClinicalTrials.gov) | April 1, 2019 | 26/7/2018 | EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study) | EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA) | Palindromic Rheumatism, Wrist | Drug: Abatacept Injection;Drug: hydroxycloroquina | Fundacion Clinic per a la Recerca Biomédica | NULL | Not yet recruiting | 18 Years | N/A | All | 98 | Phase 4 | NULL |
| 382 | NCT03700021 (ClinicalTrials.gov) | April 2019 | 2/10/2018 | Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis | Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Abatacept + csDMARD | New York University School of Medicine | NULL | Not yet recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 383 | EUCTR2018-002202-31-BG (EUCTR) | 27/03/2019 | 30/11/2018 | A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis | A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BAT1806 INN or Proposed INN: BAT1806 Other descriptive name: TOCILIZUMAB Trade Name: RoActemra Product Name: RoActerma INN or Proposed INN: RoActemra Other descriptive name: TOCILIZUMAB | Bio-Thera Solutions, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 621 | Phase 3 | Poland;Ukraine;Georgia;Bulgaria;China | ||
| 384 | NCT03823391 (ClinicalTrials.gov) | March 27, 2019 | 29/1/2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumab | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 48 | Phase 2 | United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico |
| 385 | NCT03885037 (ClinicalTrials.gov) | March 20, 2019 | 4/3/2019 | Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis) | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis) | Rheumatoid Arthritis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | NULL | Recruiting | 0 Years | N/A | All | 300 | Japan | |
| 386 | NCT04057118 (ClinicalTrials.gov) | March 20, 2019 | 13/8/2019 | A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies | Rheumatoid Arthritis | Drug: SKI-O-703;Drug: Placebo | Oscotec Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 148 | Phase 2 | United States;Czechia;Poland;Russian Federation;Ukraine |
| 387 | ChiCTR1900021686 | 2019-03-15 | 2019-03-05 | A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis | A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis | Rheumatoid arthritis | Case Series:IGU combined with MTX ; | Nanjing Drum Tower Hospital | NULL | Pending | 18 | 70 | Both | Case Series:30; | Phase 4 | China |
| 388 | NCT03886038 (ClinicalTrials.gov) | March 15, 2019 | 2/1/2019 | Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER) | The Immunogenicity and Efficacy of Subunit Vaccine Against Herpes Zoster in RA Treated With JAK-inhibitors (VACCIMIL-ZOSTER) | Rheumatoid Arthritis;Healthy Controls | Biological: Shingrix | Region Skane | NULL | Completed | 18 Years | N/A | All | 142 | Phase 4 | Sweden |
| 389 | ChiCTR1900021808 | 2019-03-08 | 2019-03-11 | A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects | A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects | Active rheumatoid arthritis | 1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg; | JiangSu Qyuns Therapeutics Co., Ltd | NULL | Recruiting | 18 | 50 | Male | 1:43;2:43; | Phase 1 | China |
| 390 | EUCTR2018-002306-31-HU (EUCTR) | 08/03/2019 | 11/02/2019 | A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599) | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom | ||
| 391 | NCT03858725 (ClinicalTrials.gov) | February 26, 2019 | 27/2/2019 | Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers | A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer | Rheumatoid Arthritis | Drug: D569 Tab.;Drug: CKD-374 5mg Tab. | Chong Kun Dang Pharmaceutical | NULL | Completed | 19 Years | 54 Years | All | 36 | Phase 1 | Korea, Republic of |
| 392 | NCT03852355 (ClinicalTrials.gov) | February 25, 2019 | 22/2/2019 | the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis | the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial | Rheumatoid Arthritis;Headache | Drug: Radiofrequency;Drug: Steroids | Assiut University | NULL | Completed | 18 Years | 60 Years | All | 60 | N/A | Egypt |
| 393 | NCT03868072 (ClinicalTrials.gov) | February 22, 2019 | 6/3/2019 | Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers | An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tofacitinib Tablet and Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers | Rheumatoid Arthritis | Drug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib Tablet | Chong Kun Dang Pharmaceutical | NULL | Completed | 19 Years | N/A | All | 40 | Phase 1 | Korea, Republic of |
| 394 | EUCTR2018-000666-10-BE (EUCTR) | 19/02/2019 | 16/11/2018 | A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom | ||
| 395 | NCT03737708 (ClinicalTrials.gov) | February 13, 2019 | 8/11/2018 | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) | Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial | Rheumatoid Arthritis (RA) | Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept | Astellas Pharma Korea, Inc. | NULL | Completed | 19 Years | 75 Years | All | 21 | Phase 4 | Korea, Republic of |
| 396 | EUCTR2018-001690-25-LT (EUCTR) | 08/02/2019 | 29/08/2018 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 648 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria | ||
| 397 | EUCTR2018-003162-13-IT (EUCTR) | 23/01/2019 | 08/11/2018 | A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib | A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128 | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ 5 mg film-coated tablets Product Name: Xeljanz 5mg INN or Proposed INN: TOFACITINIB | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Italy | ||
| 398 | EUCTR2018-000666-10-ES (EUCTR) | 23/01/2019 | 22/01/2019 | A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 399 | EUCTR2017-004543-20-ES (EUCTR) | 22/01/2019 | 25/10/2018 | EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). | EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA | PALINDROMIC RHEUMATISM;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ORENCIA INN or Proposed INN: ABATACEPT Trade Name: Dolquine INN or Proposed INN: HYDROXYCHLOROQUINE | Fundació Clínic per a la Recerca Biomèdica | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 400 | NCT03729349 (ClinicalTrials.gov) | January 15, 2019 | 1/11/2018 | Golimumab for Adherence in Rheumatoid Arthritis | Golimumab for Adherence in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab | Janssen Inc. | NULL | Active, not recruiting | 18 Years | 85 Years | All | 222 | Canada | |
| 401 | NCT03981900 (ClinicalTrials.gov) | January 4, 2019 | 7/6/2019 | IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis | IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study. | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 500 | France | |
| 402 | EUCTR2018-000666-10-HU (EUCTR) | 03/01/2019 | 29/10/2018 | A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 403 | ChiCTR1800018338 | 2019-01-01 | 2018-09-12 | A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis | A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Control:Normal Saline iv. besides MTX treatment;Treatment:GMSC iv. besides MTX treatment; | theThird Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 18 | 65 | Both | Control:123;Treatment:123; | I (Phase 1 study) | China |
| 404 | NCT03896594 (ClinicalTrials.gov) | December 24, 2018 | 28/3/2019 | A Multiple Dose of HL237 in Healthy Male Subject | A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | NULL | Recruiting | 20 Years | 45 Years | Male | 36 | Phase 1 | Korea, Republic of |
| 405 | NCT03574545 (ClinicalTrials.gov) | December 19, 2018 | 21/6/2018 | Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: ianalumab | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 65 Years | All | 48 | Phase 1 | Germany;Jordan |
| 406 | NCT03830203 (ClinicalTrials.gov) | December 19, 2018 | 22/1/2019 | Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: BAT1806;Drug: Actemra(EU-licensed) | Bio-Thera Solutions | NULL | Completed | 18 Years | N/A | All | 621 | Phase 3 | China |
| 407 | NCT03784261 (ClinicalTrials.gov) | December 17, 2018 | 17/12/2018 | Usefulness of Non TNF Usage in RA Patients | Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Drug: Salirumab;Drug: Drug: Tocilizmab;Drug: Drug: Abatacept | Shinshu University | NULL | Recruiting | 20 Years | 100 Years | All | 90 | Phase 2 | Japan |
| 408 | EUCTR2018-000666-10-GB (EUCTR) | 17/12/2018 | 24/10/2018 | A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom | ||
| 409 | EUCTR2018-001690-25-PL (EUCTR) | 11/12/2018 | 25/09/2018 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 564 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina | ||
| 410 | NCT04204603 (ClinicalTrials.gov) | November 30, 2018 | 17/12/2019 | A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: CKD-506;Drug: Placebo | Chong Kun Dang Pharmaceutical | NULL | Completed | 18 Years | 65 Years | All | 122 | Phase 2 | Czechia;Georgia;Poland;Russian Federation;Ukraine |
| 411 | NCT03789292 (ClinicalTrials.gov) | November 26, 2018 | 27/12/2018 | A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P17 SC;Biological: Humira SC | Celltrion | NULL | Active, not recruiting | 18 Years | 75 Years | All | 564 | Phase 3 | Bulgaria |
| 412 | NCT03755466 (ClinicalTrials.gov) | November 21, 2018 | 21/11/2018 | Examination of Efficacy and Safety of Baricitinib in RA Patients | Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib | Rheumatoid Arthritis | Drug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz] | Shinshu University | NULL | Recruiting | 20 Years | N/A | All | 90 | Phase 2 | Japan |
| 413 | NCT03980639 (ClinicalTrials.gov) | November 20, 2018 | 18/1/2019 | Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase | Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase | Rheumatoid Arthritis | Drug: patient treated with DMARD | University Hospital, Toulouse | NULL | Recruiting | 18 Years | N/A | All | 594226 | France | |
| 414 | NCT03852888 (ClinicalTrials.gov) | November 14, 2018 | 7/2/2019 | Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients | Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients | Rheumatoid Arthritis | Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level | CHU de Reims | NULL | Completed | 18 Years | N/A | All | 62 | N/A | France |
| 415 | EUCTR2018-001690-25-HU (EUCTR) | 13/11/2018 | 14/08/2018 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 564 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina | ||
| 416 | NCT03707535 (ClinicalTrials.gov) | November 12, 2018 | 12/10/2018 | To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P13;Biological: Remicade | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 270 | Phase 3 | China |
| 417 | NCT03714022 (ClinicalTrials.gov) | November 9, 2018 | 18/10/2018 | A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes | A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 140 | Phase 1 | United States |
| 418 | EUCTR2018-001690-25-BG (EUCTR) | 05/11/2018 | 19/09/2018 | Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis | Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 648 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of | ||
| 419 | ChiCTR1800019277 | 2018-11-01 | 2018-11-02 | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | Rheumatoid Arthritis | Control group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid; | Shanghai Traditional Medicine University Affiliated Guanghua Hospital | NULL | Recruiting | 18 | 65 | Both | Control group:22;Treatment group 1:22;Treatment group 2:22; | China | |
| 420 | NCT04267614 (ClinicalTrials.gov) | November 1, 2018 | 11/2/2020 | This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients. | Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept | Arthritis Rheumatoid | Drug: Etanercept | Pfizer | NULL | Completed | N/A | N/A | All | 1226 | Iraq | |
| 421 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Cannabidiol tablet 10 mg Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark | ||
| 422 | ChiCTR1900026079 | 2018-10-25 | 2019-09-20 | Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study | Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study | Rheumatoid Arthritis | Experimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets; | Longhua Hospital Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | Experimental group:60;Control group:60; | Phase 4 | China |
| 423 | NCT03718611 (ClinicalTrials.gov) | October 22, 2018 | 23/10/2018 | To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects | A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects | Rheumatoid Arthritis | Drug: BR9001;Drug: BR900A | Boryung Pharmaceutical Co., Ltd | NULL | Completed | 19 Years | 50 Years | All | 36 | Phase 1 | Korea, Republic of |
| 424 | EUCTR2018-001377-24-CZ (EUCTR) | 09/10/2018 | 14/10/2019 | Not available. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CKD-506 INN or Proposed INN: Not yet assigned | Chong Kun Dang Pharmaceutical Corporation (CKD) | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Poland;Ukraine;Russian Federation;Georgia | ||
| 425 | NCT03682705 (ClinicalTrials.gov) | October 8, 2018 | 21/9/2018 | A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis. | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 242 | Phase 2 | United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland |
| 426 | JPRN-JapicCTI-184031 | 02/10/2018 | 09/07/2018 | A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy | A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy | Rheumatoid Arthritis (RA) | Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Taisho Pharmaceutical co., LTD | NULL | complete | 20 | BOTH | 135 | Phase 3 | Japan | |
| 427 | NCT03770702 (ClinicalTrials.gov) | October 1, 2018 | 7/12/2018 | Statins and ARBs on Rheumatoid Activity | Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients | Rheumatoid Arthritis | Drug: Angiotensin receptor blockers;Drug: Statins | Sherief Abd-Elsalam | NULL | Recruiting | 18 Years | 65 Years | All | 45 | Phase 3 | Egypt |
| 428 | NCT03546335 (ClinicalTrials.gov) | October 1, 2018 | 30/4/2018 | Zr-89 Cimzia PET Imaging Rheumatoid Arthritis | Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 89Zr-DFO-CZP | Robert Flavell, MD, PhD | NULL | Suspended | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 429 | NCT03770923 (ClinicalTrials.gov) | October 1, 2018 | 7/12/2018 | Effect of Some Drugs on Rheumatoid Arithritis Activity | Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis | Rheumatoid Arthritis | Drug: Rupatadine;Drug: Montelukast | Sherief Abd-Elsalam | NULL | Recruiting | 18 Years | N/A | All | 75 | Phase 3 | Egypt |
| 430 | NCT03593837 (ClinicalTrials.gov) | October 1, 2018 | 10/7/2018 | Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis | Huang Qi Gui Zhi Wu Wu Granule;Rheumatoid Arthritis | Drug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placebo | Cui xuejun | NULL | Unknown status | 18 Years | 80 Years | All | 100 | Phase 2/Phase 3 | NULL |
| 431 | NCT03660059 (ClinicalTrials.gov) | September 27, 2018 | 26/8/2018 | A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) | A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX | Rheumatoid Arthritis (RA) | Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs) | Astellas Pharma China, Inc. | NULL | Completed | 18 Years | N/A | All | 385 | Phase 3 | China;Korea, Republic of;Taiwan |
| 432 | ChiCTR1800018637 | 2018-09-26 | 2018-09-30 | Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis | Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis | rheumatoid arthritis | Gold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor; | Affiliated Hospital of North Sichuan Medical College | NULL | Recruiting | Both | Target condition:150;Difficult condition:100 | China | |||
| 433 | NCT03691909 (ClinicalTrials.gov) | September 25, 2018 | 27/9/2018 | Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis | A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: HB-adMSCs | Hope Biosciences | NULL | Completed | 18 Years | 65 Years | All | 15 | Phase 1/Phase 2 | United States |
| 434 | NCT03699293 (ClinicalTrials.gov) | September 22, 2018 | 21/9/2018 | NSAIDs vs. Coxibs in the Presence of Aspirin | NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease | Rheumatoid Arthritis;Cardiovascular Diseases | Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet | Inova Health Care Services | NULL | Unknown status | 18 Years | 75 Years | All | 30 | Phase 4 | United States |
| 435 | EUCTR2018-001114-15-NL (EUCTR) | 18/09/2018 | 28/05/2018 | Predicting the risk for rheumatoid arthritis with the help of a PET scan. | Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: [18F]PEG-Folate | VU Medical Center, department of Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 436 | JPRN-JapicCTI-184229 | 12/9/2018 | 03/12/2018 | Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe | Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study- | Rheumatoid Arthritis | Intervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | DAIICHISANKYO Co., Ltd. | NULL | other | BOTH | 2000 | NA | Japan | ||
| 437 | NCT03701789 (ClinicalTrials.gov) | September 11, 2018 | 4/10/2018 | Effect of Baricitinib Treatment on Peripheral Bone in RA | Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE) | Rheumatoid Arthritis;Bone Density;Finger Joints | Drug: Baricitinib | University of Erlangen-Nürnberg Medical School | NULL | Active, not recruiting | 18 Years | 74 Years | All | 15 | Phase 3 | Germany |
| 438 | JPRN-JapicCTI-184029 | 04/9/2018 | 09/07/2018 | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | Rheumatoid Arthritis (RA) | Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain | Taisho Pharmaceutical co., LTD | NULL | complete | 20 | 75 | BOTH | 370 | Phase 2-3 | Japan |
| 439 | NCT04999683 (ClinicalTrials.gov) | September 1, 2018 | 2/8/2021 | Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis | Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis | Rheumatoid Arthritis;Osteoarthritis | Dietary Supplement: ITIS diet | University of California, San Diego | NULL | Completed | 18 Years | N/A | All | 26 | N/A | United States |
| 440 | NCT03605251 (ClinicalTrials.gov) | August 30, 2018 | 3/7/2018 | Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis. | An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: Placebos | Taiho Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | 64 Years | All | 91 | Phase 2 | Japan |
| 441 | EUCTR2015-004386-91-PL (EUCTR) | 26/08/2018 | 20/07/2016 | Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis. | A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Poland;Germany | ||
| 442 | NCT03636984 (ClinicalTrials.gov) | August 24, 2018 | 13/8/2018 | Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World | Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: recombinant TNF-a receptor: IgG Fc fusion protein | Zhejiang Hisun Pharmaceutical Co. Ltd. | NULL | Not yet recruiting | 18 Years | N/A | All | 1000 | NULL | |
| 443 | NCT04056039 (ClinicalTrials.gov) | August 14, 2018 | 21/6/2019 | Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis. | Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity. | Cardiovascular Diseases;Arthritis, Rheumatoid | Drug: Atorvastatin;Drug: Colchicine | Hospital Central Dr. Ignacio Morones Prieto | NULL | Completed | 18 Years | N/A | All | 60 | Phase 2 | Mexico |
| 444 | EUCTR2017-004079-30-PT (EUCTR) | 09/08/2018 | 29/06/2018 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Joint Research & Development Office (QMUL) | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 3 | Portugal;Spain;Belgium;Italy | ||
| 445 | EUCTR2018-002368-18-ES (EUCTR) | 25/07/2018 | 25/07/2018 | Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load | Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load | 1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO® 40 micrograms Product Code: HBVAXPRO® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN) | FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 740 | Phase 4 | Spain | ||
| 446 | NCT03618784 (ClinicalTrials.gov) | July 11, 2018 | 24/7/2018 | Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: FURESTEM-RA Inj;Other: sterile saline | Kang Stem Biotech Co., Ltd. | NULL | Completed | 19 Years | 80 Years | All | 33 | Phase 1/Phase 2 | Korea, Republic of |
| 447 | EUCTR2017-004079-30-ES (EUCTR) | 10/07/2018 | 21/03/2018 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel | Joint Research & Development Office (QMUL) | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 3 | Portugal;Belgium;Spain;Italy | ||
| 448 | EUCTR2017-004079-30-IT (EUCTR) | 06/07/2018 | 10/09/2021 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel | AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 3 | Portugal;Spain;Belgium;Italy | ||
| 449 | NCT03445871 (ClinicalTrials.gov) | July 2, 2018 | 20/2/2018 | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate | Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate | Rheumatoid Arthritis | Biological: Blood sample;Diagnostic Test: CRQ | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 60 | Phase 4 | France |
| 450 | EUCTR2016-002344-16-GB (EUCTR) | 28/06/2018 | 29/11/2017 | Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency. | Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Benepali Product Name: Benepali INN or Proposed INN: ETANERCEPT | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 451 | JPRN-UMIN000033059 | 2018/06/20 | 20/06/2018 | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture | A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty | Hokusuikai Kinen Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 120 | Not selected | Japan |
| 452 | NCT03606876 (ClinicalTrials.gov) | June 13, 2018 | 12/7/2018 | Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects | A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects | Rheumatoid Arthritis | Drug: BAT1806 injection | Bio-Thera Solutions | NULL | Completed | 18 Years | 55 Years | Male | 138 | Phase 1 | China |
| 453 | NCT03550833 (ClinicalTrials.gov) | June 13, 2018 | 28/5/2018 | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Arthritis, Rheumatoid;Stress Disorder | Behavioral: Questionnaire;Biological: blood sample | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 152 | France | |
| 454 | NCT03535402 (ClinicalTrials.gov) | June 1, 2018 | 9/5/2018 | Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics | Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score. | Rheumatoid Arthritis | Drug: Sarilumab | Gaylis, Norman B., M.D. | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 455 | NCT03522415 (ClinicalTrials.gov) | May 28, 2018 | 29/4/2018 | Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Moderately to Severely Active Rheumatoid Arthritis | Drug: HLX01;Drug: Methotrexate(MTX) | Shanghai Henlius Biotech | NULL | Completed | 18 Years | 75 Years | All | 275 | Phase 3 | China |
| 456 | NCT03410056 (ClinicalTrials.gov) | May 22, 2018 | 3/1/2018 | Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis RA | Drug: AMG 592;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | 70 Years | All | 36 | Phase 1/Phase 2 | United States;Bulgaria;Germany;Poland;Spain |
| 457 | EUCTR2017-001944-36-ES (EUCTR) | 21/05/2018 | 10/10/2017 | Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG592 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand | ||
| 458 | NCT03508713 (ClinicalTrials.gov) | May 13, 2018 | 4/6/2017 | Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND) | Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China | Rheumatoid Arthritis | Drug: disease modified antirheumatic drugs or biological agents | Nanfang Hospital of Southern Medical University | Southern Medical University, China | Not yet recruiting | 18 Years | N/A | All | 200 | NULL | |
| 459 | EUCTR2016-000933-37-BG (EUCTR) | 09/05/2018 | 12/01/2018 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 460 | EUCTR2017-004054-41-BE (EUCTR) | 07/05/2018 | 15/03/2018 | COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA | CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 | early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: etanercept INN or Proposed INN: ETANERCEPT INN or Proposed INN: LEFLUNOMIDE | University Hospitals Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Belgium | ||
| 461 | EUCTR2016-002569-68-GB (EUCTR) | 04/05/2018 | 18/05/2018 | Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease | Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL | Rheumatoid-associated Interstitial Lung Disease (RA-ILD) MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT | Cambridge University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | ||
| 462 | ChiCTR1800015615 | 2018-05-01 | 2018-04-11 | Clinical observation of the protective effect of iguratimod on rheumatoid arthritis | Clinical observation of the protective effect of iguratimod on rheumatoid arthritis | Rheumatoid Arthritis | first:MTX;second:MTX in combination with Irammod;third:MTX and LEF;fourth:MTX, LEF and Irammod; | Tianjin First Central Hospital | NULL | Pending | 18 | 75 | Both | first:30;second:30;third:30;fourth:30; | China | |
| 463 | NCT03435601 (ClinicalTrials.gov) | April 18, 2018 | 31/1/2018 | A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | Rheumatoid Arthritis | Drug: Anifrolumab;Drug: Placebos | Josef Smolen, Univ. Prof. Dr. | NULL | Recruiting | 18 Years | 70 Years | All | 24 | Phase 2 | Austria |
| 464 | JPRN-jRCTs071180018 | 13/04/2018 | 15/02/2019 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Kawakami Atsushi | NULL | Complete | >= 20age old | Not applicable | Both | 44 | Phase 4 | Japan |
| 465 | JPRN-UMIN000030575 | 2018/03/31 | 26/12/2017 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Daiichi Sankyo Company, Limited | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 44 | Not applicable | Japan |
| 466 | NCT03478111 (ClinicalTrials.gov) | March 30, 2018 | 16/3/2018 | CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade | Rheumatoid Arthritis | Drug: CMAB008;Drug: MTX;Drug: Remicade | Shanghai Biomabs Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 390 | Phase 3 | China |
| 467 | JPRN-UMIN000031890 | 2018/03/21 | 25/03/2018 | Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty | Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty - Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty | knee osteoarthritis or knee rheumatoid arthritis | Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL | Daiyukai General Hospital | NULL | Complete: follow-up continuing | 20years-old | 100years-old | Male and Female | 120 | Phase 3 | Japan |
| 468 | EUCTR2017-001944-36-BG (EUCTR) | 13/03/2018 | 24/10/2017 | Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG592 INN or Proposed INN: N/A Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 153 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand | ||
| 469 | NCT03100253 (ClinicalTrials.gov) | March 1, 2018 | 17/3/2017 | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation | Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol | Mario Negri Institute for Pharmacological Research | NULL | Terminated | 18 Years | N/A | All | 208 | Phase 4 | Italy |
| 470 | ChiCTR1800014872 | 2018-03-01 | 2018-02-12 | Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty | Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial | osteoarthritis or rheumatoid arthritis | Experimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia; | Peking Union Medical College Hospital | NULL | Pending | Both | Experimental group:50;Control group:50; | China | |||
| 471 | JPRN-UMIN000031692 | 2018/03/01 | 12/03/2018 | Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty | Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA | knee osteoarthritis rheumatoid arthritis | Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight. Control group:Fentanyl sustained intravenous administration given after operation end. | Yamaguchi University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 472 | ChiCTR1800014584 | 2018-03-01 | 2018-01-22 | Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty. | Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty. | Knee osteoartritis;Rheumatoid arthritis | Experimental group:Asprin;Controlled group:Rivaroxaban; | Department of Orthopaedics, West China Hospital, Sichuan University | NULL | Pending | 70 | 100 | Both | Experimental group:90;Controlled group:30; | China | |
| 473 | EUCTR2017-004079-30-BE (EUCTR) | 19/02/2018 | 19/02/2018 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel | Joint Research & Development Office (QMUL) | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | Portugal;Spain;Belgium;Italy | ||
| 474 | EUCTR2017-004348-39-FR (EUCTR) | 15/02/2018 | 16/01/2018 | Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients | Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU | rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: methotrexate Product Code: 1 | CHU Saint-Etienne | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | France | ||
| 475 | JPRN-UMIN000030760 | 2018/02/09 | 09/02/2018 | A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology | A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology - A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology | Hip joint disease scheduled for total hip arthroplasty(THA) (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture) | Using patient specific guide linked with 3D surgical support software for THA | National Hospital Organization Nagoya Medical Center | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 3 | Not selected | Japan |
| 476 | EUCTR2016-003630-25-NL (EUCTR) | 08/02/2018 | 06/09/2017 | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2640 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 477 | EUCTR2017-002878-38-NL (EUCTR) | 07/02/2018 | 12/09/2017 | Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis | Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA | Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Orencia 125 mg INN or Proposed INN: ABATACEPT | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 4 | Netherlands | ||
| 478 | NCT03455842 (ClinicalTrials.gov) | February 1, 2018 | 22/2/2018 | The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis | International Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid Arthritis | Seropositive RA | Biological: BCD-089, 162 mg, s/c, qw;Biological: BCD-089, 162 mg, s/c, q2w;Drug: placebo | Biocad | NULL | Completed | 18 Years | 80 Years | All | 105 | Phase 2 | Belarus;Russian Federation |
| 479 | NCT04022525 (ClinicalTrials.gov) | February 1, 2018 | 15/7/2019 | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Rheumatoid Arthritis | Drug: Leflunomide 20Mg Tab | Assiut University | NULL | Completed | 18 Years | N/A | All | 80 | Egypt | |
| 480 | NCT01694693 (ClinicalTrials.gov) | January 31, 2018 | 24/9/2012 | Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study | Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | NULL |
| 481 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 482 | EUCTR2017-002753-11-FI (EUCTR) | 25/01/2018 | 08/11/2017 | The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis | The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17 | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Xeljanz Product Code: PRD4862257 Other descriptive name: TOFACITINIB CITRATE Trade Name: Tofacitinib Product Code: PRD4862257 | Tampere University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 4 | Finland | ||
| 483 | NCT03227419 (ClinicalTrials.gov) | January 22, 2018 | 19/7/2017 | Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders | Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial | Arthritis, Rheumatoid | Drug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled Syringe | Lille Catholic University | NULL | Recruiting | 18 Years | N/A | All | 224 | Phase 4 | France |
| 484 | NCT03368235 (ClinicalTrials.gov) | January 18, 2018 | 3/11/2017 | Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: AZD9567;Drug: Prednisolone | AstraZeneca | NULL | Completed | 18 Years | 80 Years | All | 21 | Phase 2 | Netherlands;Sweden;Denmark |
| 485 | JPRN-UMIN000030828 | 2018/01/15 | 15/01/2018 | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. - EVIDENCE study | Rheumatoid ArthritisOsteoporosis | zoledronic acid denosumab | Osaka City University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 500 | Not selected | Japan |
| 486 | EUCTR2016-004038-24-RO (EUCTR) | 12/01/2018 | 26/05/2022 | A 12-week study of a new treatment, MBS2320, in Patients with Rheumatoid Arthritis Taking Methotrexate | A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients with Active Rheumatoid Arthritis receiving Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MBS2320 INN or Proposed INN: 4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulphonamide | Modern Biosciences plc | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Romania;Georgia;Moldova, Republic of | ||
| 487 | ChiCTR1800014404 | 2018-01-11 | 2018-01-11 | Evaluation of clinical curative effect of Bushen Quhan Wang Decoction in the treatment of kidney deficiency and cold dampness syndrome of rheumatoid arthritis | Evaluation of clinical curative effect of Bushen Quhan Wang Decoction in the treatment of kidney deficiency and cold dampness syndrome of rheumatoid arthritis | rheumatoid arthritis | treatment group :MTX+traditional Chinese medicine ;control group :MTX; | China-Japan Friendship Hospital | NULL | Recruiting | 16 | 70 | Both | treatment group :36;control group :36; | China | |
| 488 | EUCTR2017-003259-40-ES (EUCTR) | 04/01/2018 | 24/10/2017 | Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial. | Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial. | Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: amoxicilina INN or Proposed INN: AMOXICILLIN Product Name: metronidazol INN or Proposed INN: METRONIDAZOLE Other descriptive name: metronidazol | Dra Beatriz Lozano-Hospital Universitario de Canarias | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Spain | ||
| 489 | NCT03445715 (ClinicalTrials.gov) | January 3, 2018 | 1/2/2018 | ART-I02 in Patients With Rheumatoid Arthritis With Inflamed Wrists | A Single Dose Clinical Trial to Study the Safety of ART-I02 in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Genetic: ART-I02 | Arthrogen | NULL | Unknown status | 18 Years | N/A | All | 15 | Phase 1 | Canada |
| 490 | NCT02955212 (ClinicalTrials.gov) | January 3, 2018 | 2/11/2016 | A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 338 | Phase 3 | Brazil;China;Korea, Republic of |
| 491 | JPRN-UMIN000030237 | 2018/01/01 | 03/12/2017 | Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial | Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial - Additional postoperative intravenous tranexamic acid administration versus placebo in total knee arthroplasty | Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis | Additional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. | Hokusuikai Kinen Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 492 | NCT02795299 (ClinicalTrials.gov) | January 2018 | 2/5/2016 | Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis | Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa Antagonist | Rheumatoid Arthritis | Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo | Bird Rock Bio, Inc. | Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 493 | NCT04312815 (ClinicalTrials.gov) | December 28, 2017 | 16/3/2020 | A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX | A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis(RA) | Drug: SM03;Drug: Placebo;Drug: MTX | SinoMab Pty Ltd | NULL | Recruiting | 18 Years | 70 Years | All | 510 | Phase 3 | China |
| 494 | JPRN-jRCTs031180050 | 26/12/2017 | 07/12/2018 | Hydroxychloroquine for Japanese patients with rheumatoid arthritis | Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis | Rheumatoid arthritis;D001172 | Treatment with hydroxychloroquine for 24 weeks | Kaneko Yuko | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 120 | Phase 2-3 | Japan |
| 495 | EUCTR2017-001970-41-DK (EUCTR) | 21/12/2017 | 15/09/2017 | Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial | Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) | Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Humira Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: L04AB05 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Enbrel Product Name: Etanercept Product Code: L04AB01 INN or Proposed INN: ETANERCEPT | MD, PhD Salome Kristensen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Denmark | ||
| 496 | EUCTR2014-000555-93-ES (EUCTR) | 18/12/2017 | 10/10/2017 | Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia | Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia | Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 3 | Czech Republic;Brazil;Spain;Germany | ||
| 497 | EUCTR2017-001717-92-AT (EUCTR) | 11/12/2017 | 17/08/2017 | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA) | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA | High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab (MEDI-546) INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Austria;Switzerland;Italy | ||
| 498 | NCT03254966 (ClinicalTrials.gov) | November 24, 2017 | 15/8/2017 | Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 70 Years | All | 194 | Phase 2 | China |
| 499 | EUCTR2017-001944-36-PL (EUCTR) | 23/11/2017 | 11/10/2017 | Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG 592 INN or Proposed INN: AMG592 Other descriptive name: AMG592 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 153 | Phase 1;Phase 2 | United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom | ||
| 500 | NCT03334851 (ClinicalTrials.gov) | November 17, 2017 | 3/11/2017 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 74 | Phase 1 | United States;Puerto Rico |
| 501 | EUCTR2017-003425-15-DK (EUCTR) | 10/11/2017 | 12/09/2017 | Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian) | Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian) | Treatment of synovitis among rheumatoid arthritis patients MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebsrkhormon | Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Denmark | ||
| 502 | EUCTR2017-000838-64-NL (EUCTR) | 10/11/2017 | 13/06/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 503 | NCT04178070 (ClinicalTrials.gov) | November 6, 2017 | 24/11/2019 | Phase ? Clinical Trial of Gerilimzumab Injection in Healthy Subjects | A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects. | Rheumatoid Arthritis | Biological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mg | Genor Biopharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 58 | Phase 1 | China |
| 504 | NCT03357471 (ClinicalTrials.gov) | November 3, 2017 | 23/11/2017 | Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 505 | NCT03329885 (ClinicalTrials.gov) | November 2, 2017 | 31/10/2017 | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis | A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis | Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis | Drug: BMS-986251;Other: Placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 70 Years | All | 38 | Phase 1/Phase 2 | Netherlands |
| 506 | EUCTR2017-000384-32-BG (EUCTR) | 02/11/2017 | 12/07/2017 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 363 | Phase 2 | United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 507 | NCT03387423 (ClinicalTrials.gov) | November 2, 2017 | 7/12/2017 | Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis | ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 1500 | Germany | |
| 508 | JPRN-UMIN000029797 | 2017/11/02 | 02/11/2017 | Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial | Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial | Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritis | The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of fascia, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously. The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of the fascia, 10 mL of normal saline was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously. | Hokusuikai Kinen Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 509 | JPRN-JapicCTI-173747 | 01/11/2017 | 25/10/2017 | Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - | Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - | Rheumatoid Arthritis | Intervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | DAIICHISANKYO Co., Ltd. | NULL | complete | BOTH | 1000 | NA | Japan | ||
| 510 | JPRN-UMIN000029759 | 2017/11/01 | 01/11/2017 | Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial - Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 32 | Not selected | Japan |
| 511 | NCT03440892 (ClinicalTrials.gov) | November 1, 2017 | 14/2/2018 | Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients | Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin | Rheumatoid Arthritis | Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinib | Vastra Gotaland Region | NULL | Recruiting | 20 Years | N/A | All | 2500 | Sweden | |
| 512 | NCT02647762 (ClinicalTrials.gov) | October 30, 2017 | 16/12/2015 | CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis | A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX | Can-Fite BioPharma | NULL | Active, not recruiting | 18 Years | 75 Years | All | 525 | Phase 3 | Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia |
| 513 | NCT03337815 (ClinicalTrials.gov) | October 28, 2017 | 22/10/2017 | A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model | Rheumatoid Arthritis | Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Recruiting | 45 Years | 70 Years | All | 264 | Phase 2/Phase 3 | China |
| 514 | NCT03324412 (ClinicalTrials.gov) | October 28, 2017 | 25/10/2017 | Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Treatment of MTX;Drug: Treatment of MTX and TwHF | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Not yet recruiting | 45 Years | 70 Years | All | 216 | Phase 2/Phase 3 | NULL |
| 515 | NCT03288584 (ClinicalTrials.gov) | October 27, 2017 | 16/9/2017 | Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis | The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Inflammation | Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents. | University of Athens | NULL | Recruiting | 18 Years | 80 Years | All | 60 | Greece | |
| 516 | EUCTR2016-002126-36-IT (EUCTR) | 26/10/2017 | 31/01/2018 | A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 | F. Hoffmann - Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Spain;Poland;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 517 | EUCTR2017-000149-30-GB (EUCTR) | 25/10/2017 | 05/09/2017 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1 | Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet INN or Proposed INN: Pirfenidone | University Hospitals of Leicester NHS Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Australia;United Kingdom | ||
| 518 | EUCTR2016-004834-11-GB (EUCTR) | 23/10/2017 | 16/08/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR0686 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR6086 Trade Name: Methotrexate ® 2.5mg Tablets Product Name: Methotrexate ® 2.5mg Tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 519 | NCT04178850 (ClinicalTrials.gov) | October 13, 2017 | 25/11/2019 | Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection | A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection. | Rheumatoid Arthritis | Biological: GB242;Biological: Infliximab | Genor Biopharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 568 | Phase 3 | China |
| 520 | NCT03163966 (ClinicalTrials.gov) | October 5, 2017 | 8/5/2017 | A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis, DMARD-naive and Early Disease Patients | Drug: CR6086;Drug: Methotrexate;Drug: Placebo | Rottapharm Biotech | NULL | Completed | 18 Years | N/A | All | 248 | Phase 2 | Czechia |
| 521 | JPRN-UMIN000029003 | 2017/10/01 | 05/09/2017 | Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial - Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty No percutaneous periarticular analgesic injection at one day after total knee arthroplasty | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 522 | NCT03257852 (ClinicalTrials.gov) | September 29, 2017 | 20/8/2017 | A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis (RA) | Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy | Astellas Pharma Inc | NULL | Completed | 20 Years | N/A | All | 66 | Phase 2 | Japan |
| 523 | EUCTR2016-005017-45-PL (EUCTR) | 27/09/2017 | 19/06/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 524 | EUCTR2017-000384-32-CZ (EUCTR) | 26/09/2017 | 26/07/2017 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 363 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 525 | EUCTR2016-004300-65-BE (EUCTR) | 26/09/2017 | 20/01/2017 | Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). | Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). - SCINTRA TRIS | rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL | Ghent University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Belgium | ||
| 526 | EUCTR2012-003655-11-FR (EUCTR) | 18/09/2017 | 28/09/2015 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany | ||
| 527 | NCT03262740 (ClinicalTrials.gov) | September 11, 2017 | 24/8/2017 | The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients | The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects | Rheumatoid Arthritis | Drug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol) | Bristol-Myers Squibb | NULL | Completed | 18 Years | 40 Years | Female | 58 | Phase 1 | United States |
| 528 | EUCTR2017-000838-64-SE (EUCTR) | 11/09/2017 | 19/05/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: - | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 529 | EUCTR2016-004834-11-PL (EUCTR) | 05/09/2017 | 17/07/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of | ||
| 530 | EUCTR2016-004834-11-BG (EUCTR) | 04/09/2017 | 01/06/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of | ||
| 531 | NCT04177173 (ClinicalTrials.gov) | September 1, 2017 | 7/4/2019 | Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis | Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis. | Arthritis, Rheumatoid | Drug: Simvastatin 20 mg;Drug: Methotrexate 10 mg | King Edward Medical University | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | Pakistan |
| 532 | NCT03241446 (ClinicalTrials.gov) | September 2017 | 25/7/2017 | Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) | A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Tilmanocept | Navidea Biopharmaceuticals | NULL | Withdrawn | 30 Years | 65 Years | All | 0 | Phase 1 | NULL |
| 533 | EUCTR2017-000838-64-DK (EUCTR) | 25/08/2017 | 13/06/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: - | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 534 | EUCTR2017-000947-41-FR (EUCTR) | 18/08/2017 | 21/06/2017 | ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS. | ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR | Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie | Groupement des Hôpitaux de l’Institut Catholique de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | France | |||
| 535 | EUCTR2016-001987-12-IT (EUCTR) | 18/08/2017 | 05/01/2021 | Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF | Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI | SOCIETA' ITALIANA DI REUMATOLOGIA - SIR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 4 | Italy | ||
| 536 | EUCTR2016-004834-11-CZ (EUCTR) | 16/08/2017 | 02/08/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 537 | NCT03245515 (ClinicalTrials.gov) | August 15, 2017 | 8/8/2017 | A Study of BMS-986195 in Healthy Male Subjects | Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects | Rheumatoid Arthritis | Drug: BMS-986195 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | Netherlands |
| 538 | NCT03160001 (ClinicalTrials.gov) | August 15, 2017 | 11/5/2017 | Niclosamide With Etanercept in Rheumatoid Arthritis | Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study | Rheumatoid Arthritis (RA) | Drug: Placebo;Drug: Niclosamide;Drug: Etanercept | Faiq Gorial | NULL | Completed | 18 Years | N/A | All | 110 | Phase 1/Phase 2 | Iraq |
| 539 | NCT03156023 (ClinicalTrials.gov) | August 14, 2017 | 15/5/2017 | Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis | A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 570;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 75 Years | All | 34 | Phase 1 | United States;Germany |
| 540 | EUCTR2016-003630-25-DE (EUCTR) | 14/08/2017 | 13/04/2017 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Jyseleca 100 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Jyseleca 200 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand | ||
| 541 | NCT03327454 (ClinicalTrials.gov) | August 10, 2017 | 11/10/2017 | Benepali® PEN Patient Satisfaction Survey | Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen | Rheumatoid Arthritis;Spondyloarthropathies | Biological: Benepali | Biogen | NULL | Completed | 18 Years | N/A | All | 500 | Germany | |
| 542 | EUCTR2016-000933-37-SE (EUCTR) | 09/08/2017 | 09/11/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 543 | EUCTR2013-005543-90-EE (EUCTR) | 07/08/2017 | 02/06/2017 | This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany | ||
| 544 | EUCTR2015-005309-35-LV (EUCTR) | 04/08/2017 | 19/05/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 545 | NCT03188081 (ClinicalTrials.gov) | August 4, 2017 | 12/6/2017 | A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept | A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 300 | Italy | |
| 546 | NCT03155347 (ClinicalTrials.gov) | August 2, 2017 | 15/5/2017 | An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | 70 Years | All | 340 | Phase 3 | China |
| 547 | NCT03215407 (ClinicalTrials.gov) | August 1, 2017 | 22/6/2017 | The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone | The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee | Rheumatoid Arthritis of Knee | Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone | Chinese PLA General Hospital | NULL | Not yet recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | NULL |
| 548 | EUCTR2016-003630-25-BE (EUCTR) | 01/08/2017 | 12/04/2017 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Jyseleca 100 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Jyseleca 200 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand | ||
| 549 | EUCTR2016-002126-36-ES (EUCTR) | 31/07/2017 | 02/06/2017 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 550 | JPRN-UMIN000028376 | 2017/07/26 | 01/08/2017 | Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis | Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis | rheumatoid arthritis | Combination of anti-rheumatic therapy and denosumab Anti-rheumatic therapy alone | Hokkaido Medical Center for Rheumatic Diseases | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 30 | Not selected | Japan |
| 551 | NCT02541955 (ClinicalTrials.gov) | July 20, 2017 | 1/9/2015 | Use of Acthar in Rheumatoid Arthritis (RA) Related Flares | Use of Acthar in Rheumatoid Arthritis Related Flares | Rheumatoid Arthritis (RA) | Drug: Acthar | Veena Ranganath, MD, MS | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | United States |
| 552 | EUCTR2016-003630-25-GB (EUCTR) | 19/07/2017 | 15/08/2017 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand | ||
| 553 | EUCTR2016-000568-41-NL (EUCTR) | 18/07/2017 | 29/06/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 554 | EUCTR2016-000569-21-NL (EUCTR) | 18/07/2017 | 29/06/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 555 | EUCTR2016-001064-11-GB (EUCTR) | 18/07/2017 | 31/03/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 556 | JPRN-jRCT2071200057 | 08/07/2017 | 25/11/2020 | Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study | A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study | Rheumatoid arthritis;D001172 | Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug | Yazawa Rie | NULL | Complete | >= 20age old | < 45age old | Male | 130 | Phase 1 | Japan |
| 557 | EUCTR2016-004834-11-DK (EUCTR) | 06/07/2017 | 11/05/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 558 | EUCTR2016-002125-11-ES (EUCTR) | 06/07/2017 | 08/05/2017 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 1;Phase 3 | Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine | ||
| 559 | NCT03189017 (ClinicalTrials.gov) | July 3, 2017 | 12/6/2017 | A Phase I Study of ICP-022 in Healthy Subjects | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | NULL | Completed | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia |
| 560 | NCT03394131 (ClinicalTrials.gov) | July 1, 2017 | 25/12/2017 | ?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients | Treatment of Carpal Tunnel in Rheumatoid Arthritis | Treatment Resistant Carpal Tunnel in RA Patients | Drug: Hylase;Drug: Insulin;Other: saline | Assiut University | NULL | Unknown status | 20 Years | 80 Years | All | 90 | N/A | Egypt |
| 561 | ChiCTR-IPR-17011566 | 2017-07-01 | 2017-06-05 | The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | Rheumatoid Arthritis;M05.901 | Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant; | the Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 65 | Both | Sirolimus group:200; Non-Sirolimus group:100; | China | |
| 562 | EUCTR2016-001825-15-IT (EUCTR) | 28/06/2017 | 16/02/2018 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy | ||
| 563 | ChiCTR-INR-17011772 | 2017-06-27 | 2017-06-28 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents | Rheumatoid Arthritis | test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group; | Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital | NULL | Recruiting | 18 | 65 | Both | test group:80;Control group:40; | China | |
| 564 | NCT03278470 (ClinicalTrials.gov) | June 26, 2017 | 7/9/2017 | A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject | A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | NULL | Completed | 20 Years | 45 Years | Male | 57 | Phase 1 | Korea, Republic of |
| 565 | EUCTR2016-001825-15-DE (EUCTR) | 26/06/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 566 | EUCTR2015-005309-35-BG (EUCTR) | 22/06/2017 | 02/05/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International, LLC. | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 567 | EUCTR2016-000933-37-NL (EUCTR) | 19/06/2017 | 18/04/2017 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 568 | NCT03239080 (ClinicalTrials.gov) | June 19, 2017 | 1/8/2017 | Effect of Denosumab in Erosion Healing in RA | Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT | Rheumatoid Arthritis | Drug: Denosumab;Other: Placebo | Chinese University of Hong Kong | NULL | Completed | 18 Years | N/A | All | 110 | Phase 2 | China |
| 569 | EUCTR2015-002887-17-FR (EUCTR) | 19/06/2017 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 570 | EUCTR2015-005309-35-GB (EUCTR) | 16/06/2017 | 09/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 571 | EUCTR2016-003630-25-SK (EUCTR) | 15/06/2017 | 04/04/2017 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Jyseleca 100 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Jyseleca 200 mg film-coated tablets Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3068 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 572 | EUCTR2016-005017-45-GB (EUCTR) | 15/06/2017 | 27/10/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 573 | EUCTR2016-000933-37-SK (EUCTR) | 15/06/2017 | 24/04/2017 | Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 313 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 574 | JPRN-UMIN000027719 | 2017/06/12 | 12/06/2017 | Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. | Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. - Effect of tapering MTX in RA patinents after add-on IGU theraoy. | rheumatoid arthritis/remission | add-on iguratimod tapering MTX continuing the treatment | Osaka Medical College | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan |
| 575 | EUCTR2016-003630-25-ES (EUCTR) | 09/06/2017 | 09/06/2017 | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 576 | EUCTR2016-000569-21-FR (EUCTR) | 08/06/2017 | 04/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 577 | EUCTR2016-003630-25-PL (EUCTR) | 07/06/2017 | 24/04/2017 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 578 | EUCTR2016-002337-30-HR (EUCTR) | 05/06/2017 | 12/09/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 579 | NCT03139136 (ClinicalTrials.gov) | May 30, 2017 | 26/4/2017 | Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis | A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: MBS2320;Drug: Placebo | Modern Biosciences plc | NULL | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Georgia;Moldova, Republic of;Romania |
| 580 | EUCTR2016-003630-25-HU (EUCTR) | 29/05/2017 | 12/04/2017 | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2640 | Phase 3 | Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong | ||
| 581 | EUCTR2016-002337-30-DE (EUCTR) | 24/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 269 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 582 | EUCTR2015-005309-35-DE (EUCTR) | 23/05/2017 | 24/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia | ||
| 583 | EUCTR2015-005309-35-PL (EUCTR) | 19/05/2017 | 17/03/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Belarus;United States;Czechia;Estonia;Taiwan;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Georgia;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 584 | JPRN-UMIN000027250 | 2017/05/15 | 08/05/2017 | Precision medicine of methotrexate in the patients with rheumatoid arthritis | Precision medicine of methotrexate in the patients with rheumatoid arthritis - Methotrexate precision medicine | Rheumatoid arthritis | MTX administration | Keio UniversityFukuoka Tokushukai Hospital | NULL | Recruiting | 20years-old | 90years-old | Male and Female | 50 | Not selected | Japan |
| 585 | NCT03193957 (ClinicalTrials.gov) | May 15, 2017 | 19/6/2017 | An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis | An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Device: Autoinjector | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 2 | Poland |
| 586 | NCT03131973 (ClinicalTrials.gov) | May 13, 2017 | 25/4/2017 | Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin | Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants | Rheumatoid Arthritis | Drug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: Pravastatin | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 26 | Phase 1 | United States |
| 587 | EUCTR2016-005017-45-HU (EUCTR) | 12/05/2017 | 13/03/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 588 | EUCTR2016-005017-45-BG (EUCTR) | 11/05/2017 | 06/04/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 589 | NCT03241108 (ClinicalTrials.gov) | May 10, 2017 | 26/6/2017 | Study of an Anti-TLR4 mAb in Rheumatoid Arthritis | Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: NI-0101;Other: Placebo | NovImmune SA | NULL | Completed | 18 Years | N/A | All | 90 | Phase 2 | Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia |
| 590 | EUCTR2014-005368-13-IT (EUCTR) | 10/05/2017 | 16/02/2018 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB | ARCHIGEN BIOTECH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 591 | EUCTR2016-000897-39-DE (EUCTR) | 10/05/2017 | 27/10/2016 | An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis. | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany | ||
| 592 | EUCTR2016-001825-15-BE (EUCTR) | 08/05/2017 | 28/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 593 | EUCTR2016-002337-30-CZ (EUCTR) | 03/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 594 | EUCTR2016-000933-37-CZ (EUCTR) | 02/05/2017 | 22/11/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 595 | EUCTR2016-000569-21-DE (EUCTR) | 02/05/2017 | 04/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 596 | EUCTR2016-001825-15-HU (EUCTR) | 01/05/2017 | 22/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 597 | EUCTR2016-000933-37-DE (EUCTR) | 27/04/2017 | 17/10/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 598 | EUCTR2016-001064-11-CZ (EUCTR) | 20/04/2017 | 31/03/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 599 | EUCTR2016-000570-37-DE (EUCTR) | 19/04/2017 | 24/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 600 | EUCTR2016-000568-41-DE (EUCTR) | 19/04/2017 | 24/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 601 | EUCTR2016-002126-36-DE (EUCTR) | 18/04/2017 | 23/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom | ||
| 602 | EUCTR2016-001064-11-PL (EUCTR) | 13/04/2017 | 12/04/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom | ||
| 603 | EUCTR2016-001825-15-BG (EUCTR) | 11/04/2017 | 07/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 604 | EUCTR2016-002337-30-BG (EUCTR) | 11/04/2017 | 30/01/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 605 | NCT02808871 (ClinicalTrials.gov) | April 7, 2017 | 20/3/2016 | Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1) | Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1) | Rheumatoid Arthritis Interstitial Lung Disease | Drug: Pirfenidone;Drug: Placebo | Brigham and Women's Hospital | NULL | Completed | 18 Years | 85 Years | All | 123 | Phase 2 | United States;Australia;Canada;United Kingdom |
| 606 | EUCTR2016-001064-11-ES (EUCTR) | 07/04/2017 | 07/04/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 607 | EUCTR2016-001825-15-GB (EUCTR) | 03/04/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany | ||
| 608 | EUCTR2016-000897-39-BE (EUCTR) | 03/04/2017 | 02/02/2017 | An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis. | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany | ||
| 609 | NCT02908490 (ClinicalTrials.gov) | April 1, 2017 | 8/7/2016 | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Arthritis, Rheumatoid;Atherosclerosis | Drug: Sildenafil;Other: Placebo | Kimberly Liang | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States |
| 610 | NCT03275025 (ClinicalTrials.gov) | April 1, 2017 | 28/8/2017 | A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Rheumatoid Arthritis | Drug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: Placebo | Yungjin Pharm. Co., Ltd. | NULL | Completed | 19 Years | 80 Years | All | 116 | Phase 2 | Korea, Republic of |
| 611 | NCT03291457 (ClinicalTrials.gov) | March 30, 2017 | 20/9/2017 | A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Glucocorticoid Agent | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 101 | Belgium | |
| 612 | EUCTR2016-001825-15-PL (EUCTR) | 29/03/2017 | 08/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 613 | EUCTR2016-002862-30-PL (EUCTR) | 28/03/2017 | 03/04/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 614 | EUCTR2015-005307-83-RO (EUCTR) | 28/03/2017 | 22/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 615 | EUCTR2016-002337-30-ES (EUCTR) | 27/03/2017 | 10/03/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 616 | NCT03178955 (ClinicalTrials.gov) | March 27, 2017 | 2/6/2017 | Circadian RA Study in Rheumatoid Arthritis Subjects | The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm | Rheumatoid Arthritis | Drug: Etanercept | University of California, Davis | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | United States | |
| 617 | EUCTR2011-004720-35-NL (EUCTR) | 22/03/2017 | 22/02/2017 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Iceland;Netherlands;Sweden | ||
| 618 | EUCTR2016-002862-30-CZ (EUCTR) | 22/03/2017 | 14/12/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 619 | EUCTR2016-001825-15-CZ (EUCTR) | 21/03/2017 | 21/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 620 | EUCTR2016-000570-37-BG (EUCTR) | 21/03/2017 | 13/02/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 621 | EUCTR2016-000568-41-BG (EUCTR) | 21/03/2017 | 24/01/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 622 | NCT03755258 (ClinicalTrials.gov) | March 16, 2017 | 21/11/2018 | Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis | A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients | Early Rheumatoid Arthritis | Drug: GCK 100 mg + Placebo 200 mg;Drug: GCK 200 mg + Placebo 100 mg;Drug: GCK 300 mg;Drug: Placebo 300mg | Zhejiang Hisun Pharmaceutical Co. Ltd. | NULL | Unknown status | 18 Years | 65 Years | All | 128 | Phase 1 | China |
| 623 | EUCTR2015-005309-35-HU (EUCTR) | 16/03/2017 | 02/02/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 624 | EUCTR2015-005309-35-CZ (EUCTR) | 16/03/2017 | 31/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 625 | EUCTR2016-002337-30-HU (EUCTR) | 16/03/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 626 | EUCTR2016-002862-30-DE (EUCTR) | 15/03/2017 | 26/01/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 627 | EUCTR2016-000933-37-BE (EUCTR) | 14/03/2017 | 24/11/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 628 | EUCTR2016-001825-15-ES (EUCTR) | 09/03/2017 | 10/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 629 | EUCTR2016-002852-26-DE (EUCTR) | 09/03/2017 | 06/10/2016 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 630 | EUCTR2015-003289-97-DE (EUCTR) | 09/03/2017 | 30/11/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 631 | EUCTR2015-005309-35-LT (EUCTR) | 06/03/2017 | 31/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 632 | EUCTR2015-005307-83-LV (EUCTR) | 03/03/2017 | 16/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 633 | EUCTR2016-002126-36-AT (EUCTR) | 01/03/2017 | 11/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany | ||
| 634 | NCT03161457 (ClinicalTrials.gov) | February 27, 2017 | 21/4/2017 | A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy | Rheumatoid Arthritis;Arthritis, Rheumatoid | Biological: JHL1101;Biological: MabThera | JHL Biotech, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 153 | Phase 1 | Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom |
| 635 | EUCTR2014-004868-38-DE (EUCTR) | 23/02/2017 | 25/05/2016 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany | ||
| 636 | EUCTR2015-003289-97-ES (EUCTR) | 20/02/2017 | 21/02/2017 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 637 | EUCTR2016-001825-15-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 638 | EUCTR2016-002862-30-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 639 | EUCTR2016-002862-30-BG (EUCTR) | 16/02/2017 | 10/01/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 640 | EUCTR2016-000568-41-PL (EUCTR) | 15/02/2017 | 14/02/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4ml s.c.injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 641 | EUCTR2016-000570-37-PL (EUCTR) | 15/02/2017 | 13/02/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Russian Federation;Hong Kong;United States;Malaysia;Thailand;Ireland;Poland;Brazil;Korea, Republic of;Slovakia;Chile;France;Serbia;Bulgaria;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Italy;Mexico;South Africa;Israel;Australia;Peru;Germany | ||
| 642 | EUCTR2016-000569-21-PL (EUCTR) | 15/02/2017 | 14/02/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 643 | NCT03667131 (ClinicalTrials.gov) | February 13, 2017 | 10/9/2018 | Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis. | Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients. | Rheumatoid Arthritis | Drug: Enalapril Maleate;Drug: Placebo | University of Guadalajara | NULL | Completed | 18 Years | 80 Years | Female | 59 | Phase 2 | Mexico |
| 644 | EUCTR2016-000568-41-IT (EUCTR) | 08/02/2017 | 17/06/2021 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response toMethotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administeredfor 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate - NA | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Methotrexate INN or Proposed INN: METOTRESSATO SALE SODICO Trade Name: Humira INN or Proposed INN: ADALIMUMAB | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico | ||
| 645 | NCT03052322 (ClinicalTrials.gov) | January 31, 2017 | 29/1/2017 | MSB11022 in Moderate to Severe Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Phase III Trial to Evaluate the Safety, Immunogenicity, and Efficacy of MSB11022 Compared With Humira® in Patients With Moderately to Severely Active Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis | Drug: MSB11022;Drug: EU-Humira | Fresenius Kabi SwissBioSim GmbH | NULL | Completed | 18 Years | N/A | All | 288 | Phase 3 | Bulgaria;Czechia;Germany;Hungary;Poland;United Kingdom;Czech Republic |
| 646 | NCT02997605 (ClinicalTrials.gov) | January 31, 2017 | 15/12/2016 | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission. | RheumatoId Arthritis | Drug: GlucoCorticoid | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | All | 102 | Phase 4 | France |
| 647 | ChiCTR-IPR-17010325 | 2017-01-31 | 2017-01-04 | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | rheumatic disease;M05.901 | Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Pending | 18 | 65 | Both | Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100; | China | |
| 648 | EUCTR2016-002862-30-HU (EUCTR) | 31/01/2017 | 23/11/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 649 | EUCTR2013-003413-18-NL (EUCTR) | 30/01/2017 | 28/09/2015 | Arthritis prevention with abatacept | Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA | The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis. MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ORENCIA 125 mg solution for injection | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 206 | Phase 2 | Netherlands;United Kingdom | ||
| 650 | EUCTR2016-000933-37-PT (EUCTR) | 30/01/2017 | 09/11/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Belarus;Portugal;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 651 | EUCTR2016-000570-37-BE (EUCTR) | 30/01/2017 | 17/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 652 | EUCTR2016-000569-21-BE (EUCTR) | 30/01/2017 | 28/10/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 653 | NCT03028467 (ClinicalTrials.gov) | January 24, 2017 | 10/1/2017 | Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis | A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acid | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 15 | Phase 1/Phase 2 | Japan |
| 654 | NCT03085940 (ClinicalTrials.gov) | January 20, 2017 | 7/2/2017 | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hydroxychloroquine;Drug: Placebo | Indonesia University | NULL | Completed | 18 Years | N/A | All | 37 | N/A | Indonesia |
| 655 | NCT02990806 (ClinicalTrials.gov) | January 19, 2017 | 21/11/2016 | A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE) | A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: NI-071;Drug: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 683 | Phase 3 | United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom |
| 656 | EUCTR2016-000933-37-IT (EUCTR) | 17/01/2017 | 07/09/2021 | Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) - M15-925 | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: Orencia 250mg powder for concentrate for solution for infusion Product Name: Abatacept Product Code: NA INN or Proposed INN: ABATACEPT | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 313 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 657 | EUCTR2016-000569-21-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 658 | EUCTR2016-000570-37-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 659 | EUCTR2016-000568-41-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 660 | NCT03112213 (ClinicalTrials.gov) | January 12, 2017 | 10/4/2017 | Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment | CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis) | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: NSAIDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 135 | Germany | |
| 661 | EUCTR2016-000897-39-HU (EUCTR) | 09/01/2017 | 19/10/2016 | An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis. | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany | ||
| 662 | EUCTR2015-003140-39-PL (EUCTR) | 09/01/2017 | 11/01/2017 | A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051 | Akros Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | ||
| 663 | EUCTR2016-002852-26-BG (EUCTR) | 05/01/2017 | 03/01/2017 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 664 | EUCTR2016-002852-26-GB (EUCTR) | 05/01/2017 | 23/09/2016 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 665 | EUCTR2016-001532-35-BG (EUCTR) | 05/01/2017 | 14/11/2016 | A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. | A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. | Moderate to Severe Rheumatoid Arthritis. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: LNP1955 | Lupin Limited | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Poland;Bulgaria | ||
| 666 | EUCTR2016-003129-40-IT (EUCTR) | 05/01/2017 | 10/09/2021 | Remission after suspension of TNF alpha therapies in RA | PHASE 4, MULTICENTER RANDOMISED STUDY, AIMED AT EVALUATING THE MAINTENANCE OF REMISSION AFTER 6, 12, 18 AND 24 MONTHS FROM SUSPENSION OF TNF-ALPHA THERAPIES (ADALIMUMAB, ETANERCEPT, INFLIXIMAB, CERTOLIZUMAB PEGOL, GOLIMUMAB) IN RHEUMATOID ARTHRITIS (RA) PATIENTS - NA | RHEUMATOID ARTHRITIS (RA) PATIENTS MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER Product Name: HUMIRA (ADALIMUMAB) Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI ALCOOL Product Name: CIMZIA (Certolizumab Pegol) Product Code: [NA] INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: ENBREL (Etanercept) Product Code: [-] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: REMICADE (INFLIXIMAB) Product Code: [-] INN or Proposed INN: INFLIXIMAB Trade Name: SIMPONI - 50 MG-SOLUZIONE PER INIEZIONE IN PENNA PRERIEMPITA-USO SOTTOCUTANEO-PENNA PRERIEMPITA(VETRO) -0.5 ML 3 (3X1) PENNE PRERIEMPITE | AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 667 | EUCTR2016-000570-37-CZ (EUCTR) | 05/01/2017 | 22/11/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 668 | EUCTR2016-000568-41-CZ (EUCTR) | 05/01/2017 | 21/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 669 | EUCTR2016-000568-41-BE (EUCTR) | 04/01/2017 | 17/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 670 | ChiCTR-INR-16010290 | 2017-01-01 | 2016-12-28 | The research for the treatment of Rheumatoid Arthritis with Warming yang and Smoothening Meridians | The research for the treatment of Rheumatoid Arthritis with Warming yang and Smoothening Meridians | Rheumatoid Arthritis | treatment group:MTX+Wen yang tong luo granule;control group:MTX; | The First Hospital Affiliated to Henan University of TCM | NULL | Recruiting | 18 | 65 | Both | treatment group:180;control group:180; | China | |
| 671 | ChiCTR-IPR-17010307 | 2017-01-01 | 2017-01-01 | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | Rheumatoid Arthritis;M05.901 | Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 65 | Both | Rapamycin group:200;Non-rapamycin group :100; | China | |
| 672 | NCT03016884 (ClinicalTrials.gov) | January 2017 | 1/1/2017 | Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients | Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation | Herpes Zoster | Biological: Zostavax vaccine | HaEmek Medical Center, Israel | NULL | Active, not recruiting | 50 Years | N/A | All | 87 | Phase 4 | Israel |
| 673 | NCT02865434 (ClinicalTrials.gov) | January 2017 | 5/8/2016 | Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA | An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls | Arthritis, Rheumatoid | Drug: Tc99m-tilmanocept;Procedure: SPECT Imaging (60 Minutes post-injection);Procedure: SPECT Imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (15 Minutes post-injection);Procedure: Whole body planar SPECT imaging (60 Minutes post-injection);Procedure: Whole body planar SPECT imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection);Procedure: Blood Collection for PK Testing (15 Mins Before Injection);Procedure: Blood Collection for PK Testing (after injection);Procedure: Blood Collection for PK Testing (15 minutes post injection);Procedure: Blood Collection for PK Testing (60 minutes post injection);Procedure: Blood Collection for PK Testing (180 minutes post injection);Procedure: Blood Collection for PK Testing (18-20 hours post injection);Procedure: Planar Image with both Hands in Field of View | Navidea Biopharmaceuticals | NULL | Completed | 18 Years | N/A | All | 39 | Phase 1/Phase 2 | United States |
| 674 | EUCTR2016-000933-37-ES (EUCTR) | 28/12/2016 | 17/11/2016 | Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand | ||
| 675 | NCT02965599 (ClinicalTrials.gov) | December 27, 2016 | 14/11/2016 | Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis | A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GSK3117391;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 2 | Poland;Romania;Mexico |
| 676 | EUCTR2016-000569-21-GB (EUCTR) | 23/12/2016 | 01/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 677 | EUCTR2016-000568-41-GB (EUCTR) | 23/12/2016 | 13/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 678 | NCT03001219 (ClinicalTrials.gov) | December 22, 2016 | 20/12/2016 | A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors | Rheumatoid Arthritis | Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520 | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland |
| 679 | EUCTR2016-001496-75-CZ (EUCTR) | 20/12/2016 | 30/09/2016 | A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria | ||
| 680 | NCT02969044 (ClinicalTrials.gov) | December 20, 2016 | 17/11/2016 | Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate | A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: PF-06651600 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 70 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia |
| 681 | EUCTR2014-004704-29-DE (EUCTR) | 19/12/2016 | 23/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 682 | EUCTR2014-004704-29-CZ (EUCTR) | 15/12/2016 | 02/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 683 | NCT02862574 (ClinicalTrials.gov) | December 15, 2016 | 8/8/2016 | Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor | Gilead Sciences | NULL | Terminated | 18 Years | 80 Years | All | 15 | Phase 2 | United States;Australia;Hungary;Taiwan |
| 684 | EUCTR2016-001496-75-PL (EUCTR) | 13/12/2016 | 03/11/2016 | A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria | ||
| 685 | EUCTR2015-003289-97-SK (EUCTR) | 12/12/2016 | 11/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 686 | EUCTR2016-000569-21-HU (EUCTR) | 12/12/2016 | 07/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 687 | EUCTR2016-002852-26-CZ (EUCTR) | 07/12/2016 | 21/09/2016 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 688 | EUCTR2016-002852-26-LT (EUCTR) | 07/12/2016 | 24/10/2016 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 689 | EUCTR2016-000933-37-LV (EUCTR) | 06/12/2016 | 31/10/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Belarus;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 690 | EUCTR2015-003140-39-BG (EUCTR) | 05/12/2016 | 23/11/2016 | A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051 | Akros Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | ||
| 691 | EUCTR2016-000570-37-HU (EUCTR) | 02/12/2016 | 19/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 692 | EUCTR2016-000568-41-HU (EUCTR) | 02/12/2016 | 19/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 693 | NCT03337165 (ClinicalTrials.gov) | December 2016 | 3/11/2017 | Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis | Safety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis | Musculoskeletal Diseases;Joint Disease;Arthritis;Arthritis, Rheumatoid;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System Diseases | Biological: tolerogenic dendritic cells | Russian Academy of Medical Sciences | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 1 | Russian Federation |
| 694 | NCT02982083 (ClinicalTrials.gov) | December 2016 | 1/12/2016 | Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis | Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Raloxifene hydrochloride;Drug: Placebo Oral Tablet | Sara Saeidi Shahri | NULL | Not yet recruiting | 50 Years | N/A | Female | 40 | N/A | NULL |
| 695 | NCT02983227 (ClinicalTrials.gov) | November 30, 2016 | 29/11/2016 | A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 | A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: GDC-0853 | Genentech, Inc. | NULL | Completed | 18 Years | 76 Years | All | 496 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of |
| 696 | EUCTR2014-004704-29-BG (EUCTR) | 29/11/2016 | 15/09/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 697 | EUCTR2016-000570-37-SK (EUCTR) | 29/11/2016 | 04/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 698 | NCT02986139 (ClinicalTrials.gov) | November 29, 2016 | 2/11/2016 | Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis | A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis | Arthritis, Rheumatoid; Arthritis, Psoriatic | Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept | Amgen | NULL | Completed | 18 Years | N/A | All | 111 | Phase 3 | United States;Puerto Rico |
| 699 | NCT02960490 (ClinicalTrials.gov) | November 26, 2016 | 3/11/2016 | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 64 | Phase 2 | Japan |
| 700 | EUCTR2014-004704-29-PL (EUCTR) | 25/11/2016 | 04/10/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany | ||
| 701 | EUCTR2016-000933-37-HU (EUCTR) | 24/11/2016 | 12/10/2016 | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 702 | EUCTR2014-005368-13-DE (EUCTR) | 22/11/2016 | 04/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 703 | JPRN-UMIN000026819 | 2016/11/21 | 01/04/2017 | A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. | A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients. | osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip | Dose: Edoxaban group; Edoxaban 15mg per day Enoxaparin gropu; Enoxaparin 2000 IU per day Intervention period: for 10 days after the surgery | Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 80 | Not selected | Japan |
| 704 | EUCTR2016-002852-26-HU (EUCTR) | 15/11/2016 | 29/09/2016 | MSB11022 in moderately to severely active rheumatoid arthritis | A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA | moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany;United Kingdom | ||
| 705 | NCT02874092 (ClinicalTrials.gov) | November 15, 2016 | 17/8/2016 | Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis | Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Ticagrelor;Drug: MTX therapy | NYU Langone Health | NULL | Completed | 18 Years | N/A | All | 9 | Phase 4 | United States |
| 706 | EUCTR2016-000570-37-GB (EUCTR) | 14/11/2016 | 17/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 707 | EUCTR2015-005307-83-DE (EUCTR) | 10/11/2016 | 24/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 708 | NCT02996500 (ClinicalTrials.gov) | November 10, 2016 | 13/10/2016 | Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 269 | Phase 2 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine |
| 709 | EUCTR2016-002908-15-NL (EUCTR) | 08/11/2016 | 23/08/2016 | REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis | REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO | Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Sint Maartenskliniek | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 710 | EUCTR2015-005308-27-DE (EUCTR) | 08/11/2016 | 09/05/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of | ||
| 711 | EUCTR2015-005800-27-PL (EUCTR) | 08/11/2016 | 03/10/2016 | Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs | A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK3117391 Product Code: GSK3117391 INN or Proposed INN: Not applicable Other descriptive name: GSK3117391 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Poland;Romania;Russian Federation | ||
| 712 | NCT02919761 (ClinicalTrials.gov) | November 7, 2016 | 26/9/2016 | Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis | A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment | Arthritis, Rheumatoid | Drug: Acthar Gel;Drug: Placebo | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 259 | Phase 4 | United States;Argentina;Mexico;Peru;Puerto Rico;Colombia |
| 713 | EUCTR2015-003334-27-FI (EUCTR) | 02/11/2016 | 17/06/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 714 | NCT02960438 (ClinicalTrials.gov) | November 2, 2016 | 3/11/2016 | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 190 | Phase 2 | Japan |
| 715 | ChiCTR-INR-16009546 | 2016-11-01 | 2016-10-21 | The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis | The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis | rheumatoid arthritis;M05.901 | IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 65 | Both | IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15; | China | |
| 716 | ChiCTR-IPR-16009029 | 2016-11-01 | 2016-08-15 | Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis | Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis | Rheumatoid arthritis | RA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid;RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid;OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed;OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Pending | 18 | 65 | Both | RA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60; | China | |
| 717 | NCT03067870 (ClinicalTrials.gov) | November 2016 | 25/2/2017 | Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis | Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis | RheumatoId Arthritis;Osteoarthritis, Knee;Osteoarthritis, Hip | Biological: Stem Cell Transplantation | Stem Cells Arabia | NULL | Active, not recruiting | 17 Years | 75 Years | All | 100 | Phase 1 | NULL |
| 718 | EUCTR2015-003334-27-RO (EUCTR) | 27/10/2016 | 28/06/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 719 | EUCTR2016-002125-11-BG (EUCTR) | 27/10/2016 | 13/10/2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;Bulgaria;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 720 | NCT03061838 (ClinicalTrials.gov) | October 27, 2016 | 20/2/2017 | Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® | Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MabThera®;Drug: Ritumax® | Biointegrator LLC | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 1 | Russian Federation |
| 721 | EUCTR2015-003289-97-PL (EUCTR) | 25/10/2016 | 17/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 722 | EUCTR2015-003289-97-AT (EUCTR) | 20/10/2016 | 12/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 723 | NCT02858492 (ClinicalTrials.gov) | October 17, 2016 | 20/7/2016 | Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | A Multicenter, Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled Study to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GSK2982772 60 mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 52 | Phase 2 | Germany;Italy;Poland;Russian Federation;Spain;United Kingdom |
| 724 | EUCTR2016-002125-11-CZ (EUCTR) | 17/10/2016 | 21/07/2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Poland;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 725 | EUCTR2016-000498-19-BG (EUCTR) | 13/10/2016 | 19/08/2016 | A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis | A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 2 | United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of | ||
| 726 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 727 | JPRN-jRCTs041180071 | 13/10/2016 | 07/03/2019 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study | Rheumatoid arthritis | At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Complete | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 728 | NCT02819726 (ClinicalTrials.gov) | October 11, 2016 | 20/6/2016 | PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: SAIT101;Biological: MabThera;Biological: Rituxan | Archigen Biotech Limited | NULL | Completed | 18 Years | 80 Years | All | 294 | Phase 1 | United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain |
| 729 | EUCTR2016-000568-41-SK (EUCTR) | 11/10/2016 | 04/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 730 | NCT02937701 (ClinicalTrials.gov) | October 10, 2016 | 30/8/2016 | Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: ABP 710;Biological: Infliximab | Amgen | NULL | Completed | 18 Years | 80 Years | All | 558 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic |
| 731 | EUCTR2014-004704-29-HU (EUCTR) | 05/10/2016 | 08/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 732 | EUCTR2015-004858-17-NL (EUCTR) | 05/10/2016 | 28/09/2016 | REMission INDuction in very early Rheumatoid Arthritis | REMission INDuction in very early Rheumatoid Arthritis - REMINDRA | Very early Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Product Name: Methotrexate Product Code: MTX INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Golimumab Product Name: Golimumab Product Code: GOL INN or Proposed INN: GOLIMUMAB | University Medical Center Utrecht (UMCU) | NULL | Not Recruiting | Female: yes Male: yes | 267 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 733 | EUCTR2016-000912-13-PL (EUCTR) | 04/10/2016 | 26/07/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Spain;Poland;Romania;Germany;Italy;United Kingdom | ||
| 734 | EUCTR2014-004704-29-ES (EUCTR) | 03/10/2016 | 05/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 735 | JPRN-UMIN000024025 | 2016/10/01 | 01/10/2016 | The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study | The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study | Rheumatoid Arthritis | receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week) receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week) | Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not applicable | Japan |
| 736 | NCT02881307 (ClinicalTrials.gov) | October 2016 | 19/8/2016 | Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet | Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet | Rheumatoid Arthritis;Overweight | Dietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendations | Veena Ranganath, MD, MS | NULL | Completed | 18 Years | N/A | All | 40 | N/A | United States |
| 737 | NCT02805010 (ClinicalTrials.gov) | October 2016 | 12/6/2016 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis (RA) | Drug: Abatacept;Other: Placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Bristol-Myers Squibb | Active, not recruiting | 18 Years | 45 Years | Both | 22 | Phase 1 | NULL |
| 738 | NCT02037737 (ClinicalTrials.gov) | September 30, 2016 | 21/11/2013 | Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting | Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 153 | NULL | |
| 739 | EUCTR2014-005368-13-ES (EUCTR) | 23/09/2016 | 15/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 740 | NCT02648035 (ClinicalTrials.gov) | September 22, 2016 | 5/1/2016 | EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis | Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study. | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 200 | Greece | |
| 741 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 742 | NCT02885181 (ClinicalTrials.gov) | September 21, 2016 | 26/8/2016 | Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | Rheumatoid Arthritis | Drug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: Methotrexate | Gilead Sciences | NULL | Completed | 18 Years | 75 Years | All | 83 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary |
| 743 | EUCTR2014-005368-13-HU (EUCTR) | 19/09/2016 | 11/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy | ||
| 744 | NCT02884635 (ClinicalTrials.gov) | September 16, 2016 | 26/8/2016 | A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate | Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX) | Rheumatoid Arthritis | Drug: ASP1707;Drug: Placebo;Drug: Methotrexate | Astellas Pharma Inc | NULL | Completed | N/A | N/A | Female | 72 | Phase 2 | Japan |
| 745 | NCT02919475 (ClinicalTrials.gov) | September 14, 2016 | 27/9/2016 | Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA) | Rheumatoid Arthritis | Drug: JTE-051;Drug: Placebo | Akros Pharma Inc. | NULL | Completed | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Mexico;Peru;Poland;Romania;Russian Federation;Ukraine |
| 746 | EUCTR2014-005368-13-CZ (EUCTR) | 13/09/2016 | 13/09/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 747 | EUCTR2012-002535-28-NL (EUCTR) | 13/09/2016 | 01/09/2016 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07 | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 4 | Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 748 | NCT03147248 (ClinicalTrials.gov) | September 12, 2016 | 7/5/2017 | A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P13 | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 407 | Phase 3 | Korea, Republic of |
| 749 | EUCTR2015-002729-21-PT (EUCTR) | 12/09/2016 | 27/04/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 750 | EUCTR2015-003335-35-SI (EUCTR) | 12/09/2016 | 28/09/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 751 | NCT02833350 (ClinicalTrials.gov) | September 9, 2016 | 12/7/2016 | Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) | A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2) | Rheumatoid Arthritis | Drug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 578 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile |
| 752 | EUCTR2016-002125-11-HU (EUCTR) | 08/09/2016 | 11/07/2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 1;Phase 3 | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 753 | EUCTR2015-003334-27-SI (EUCTR) | 07/09/2016 | 14/12/2015 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 754 | EUCTR2016-000912-13-GB (EUCTR) | 05/09/2016 | 12/06/2017 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Spain;Romania;Germany;Italy;United Kingdom | ||
| 755 | NCT02831855 (ClinicalTrials.gov) | September 1, 2016 | 11/7/2016 | Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis | Drug: CP-690,550;Drug: Methotrexate;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 694 | Phase 4 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom |
| 756 | NCT02666443 (ClinicalTrials.gov) | September 2016 | 24/1/2016 | Low Dose Dexamethasone in Supraclavicular Blocks | Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study | Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury | Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg | University of Calgary | NULL | Recruiting | 18 Years | 80 Years | Both | 306 | N/A | Canada |
| 757 | NCT03011281 (ClinicalTrials.gov) | September 2016 | 30/12/2016 | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tofacitinib | Hanyang University | NULL | Recruiting | 19 Years | N/A | All | 378 | Korea, Republic of | |
| 758 | NCT02897011 (ClinicalTrials.gov) | September 2016 | 7/9/2016 | 2-week dc of MTX and Influenza Vaccination in RA | Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial | Rheumatoid Arthritis;Influenza;Methotrexate | Drug: Methotrexate | Seoul National University Hospital | NULL | Recruiting | 18 Years | 65 Years | Both | 318 | N/A | Korea, Republic of |
| 759 | NCT03016013 (ClinicalTrials.gov) | September 2016 | 8/1/2017 | A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. | A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. | Moderate and Severe RheumatoId Arthritis | Biological: Placebo plus MTX;Biological: RC18 160 mg plus MTX | RemeGen | NULL | Recruiting | 18 Years | 65 Years | All | 480 | Phase 3 | China |
| 760 | NCT02930343 (ClinicalTrials.gov) | September 2016 | 13/9/2016 | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy | Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Terminated | 18 Years | 65 Years | All | 136 | Phase 3 | India |
| 761 | EUCTR2016-000912-13-DE (EUCTR) | 30/08/2016 | 29/06/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Spain;Romania;Germany;Italy;United Kingdom | ||
| 762 | EUCTR2015-003334-27-LT (EUCTR) | 30/08/2016 | 06/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 763 | EUCTR2015-003335-35-BG (EUCTR) | 29/08/2016 | 01/08/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 764 | EUCTR2016-000335-40-BG (EUCTR) | 23/08/2016 | 08/07/2016 | A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies. | A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 2) | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of | ||
| 765 | EUCTR2016-002125-11-LV (EUCTR) | 23/08/2016 | 01/07/2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Korea, Republic of;Bosnia and Herzegovina | ||
| 766 | NCT02628028 (ClinicalTrials.gov) | August 22, 2016 | 9/12/2015 | A Study of LY3337641 in Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study | Rheumatoid Arthritis | Drug: LY3337641;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | 65 Years | All | 286 | Phase 2 | United States;Argentina;Australia;Austria;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;South Africa;Spain;Germany |
| 767 | EUCTR2016-002125-11-EE (EUCTR) | 22/08/2016 | 05/07/2016 | Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 768 | EUCTR2015-004386-91-DE (EUCTR) | 22/08/2016 | 18/05/2016 | Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis. | A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Poland;Germany | ||
| 769 | ChiCTR-IIR-16008693 | 2016-08-20 | 2016-06-20 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis | Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo; | The First Hospital, Jilin University | NULL | Pending | 18 | 45 | Both | Abatacept Group:20;Placebo Group:2; | I (Phase 1 study) | China |
| 770 | EUCTR2015-003334-27-BG (EUCTR) | 18/08/2016 | 18/07/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 771 | NCT02705989 (ClinicalTrials.gov) | August 18, 2016 | 7/3/2016 | Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects | A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986195;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 439 | Phase 1 | Australia |
| 772 | EUCTR2015-003335-35-HU (EUCTR) | 18/08/2016 | 18/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 773 | EUCTR2016-000064-42-BG (EUCTR) | 11/08/2016 | 28/06/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria | ||
| 774 | EUCTR2015-003335-35-FI (EUCTR) | 10/08/2016 | 22/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 775 | EUCTR2015-003333-95-FI (EUCTR) | 10/08/2016 | 19/04/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 776 | EUCTR2016-001532-35-HU (EUCTR) | 08/08/2016 | 15/06/2016 | A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. | A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis. | Moderate to Severe Rheumatoid Arthritis. MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: LNP1955 | Lupin Limited | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Bulgaria | ||
| 777 | EUCTR2016-000393-37-BG (EUCTR) | 08/08/2016 | 17/06/2016 | A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma Sprl | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 778 | EUCTR2016-000064-42-HU (EUCTR) | 05/08/2016 | 06/06/2016 | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 779 | EUCTR2015-005307-83-BG (EUCTR) | 04/08/2016 | 17/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 780 | EUCTR2015-003376-75-BG (EUCTR) | 02/08/2016 | 18/07/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 781 | NCT03775824 (ClinicalTrials.gov) | August 1, 2016 | 11/12/2018 | Faecal Analyses in Rheumatoid Arthritis Therapy | Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy | Rheumatoid Arthritis | Drug: MTX start;Drug: TNF start | Region Skane | NULL | Completed | 18 Years | N/A | All | 50 | NULL | |
| 782 | NCT02892370 (ClinicalTrials.gov) | August 2016 | 2/9/2016 | Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects | An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302 | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | Male | 14 | Phase 1 | China |
| 783 | JPRN-JapicCTI-163317 | 28/7/2016 | 13/07/2016 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Intervention name : BMS-986142 INN of the intervention : - Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified | Bristol-Myers Squibb K.K. | NULL | complete | 18 | 120 | BOTH | 408 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania |
| 784 | EUCTR2015-003376-75-GR (EUCTR) | 28/07/2016 | 13/05/2016 | A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Japan;New Zealand;Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary | ||
| 785 | EUCTR2016-000064-42-SK (EUCTR) | 27/07/2016 | 03/05/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 786 | EUCTR2015-003334-27-CZ (EUCTR) | 27/07/2016 | 06/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 787 | EUCTR2015-003376-75-CZ (EUCTR) | 27/07/2016 | 03/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Australia;Bulgaria;Japan;New Zealand;Puerto Rico;Argentina;Poland;Belgium;Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico | ||
| 788 | NCT02867306 (ClinicalTrials.gov) | July 25, 2016 | 11/8/2016 | A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis | A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ASP1707;Drug: methotrexate (MTX) | Astellas Pharma Global Development, Inc. | NULL | Completed | 18 Years | 65 Years | All | 10 | Phase 1 | Moldova, Republic of |
| 789 | JPRN-UMIN000021247 | 2016/07/22 | 22/07/2016 | Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state | Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study) | Rheumatoid arthritis | Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained. | Nagoya University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 51 | Not selected | Japan |
| 790 | EUCTR2015-003333-95-LT (EUCTR) | 21/07/2016 | 09/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Stroke (ischaemic stroke or intracerebral hemorrhage) MedDRA version: 22.1;Level: PT;Classification code 10061256;Term: Ischaemic stroke;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10022754;Term: Intracerebral hemorrhage;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10042244;Term: Stroke;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Paracetamol Product Name: Paracetamol INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL Trade Name: Ceftriaxone Product Name: Ceftriaxone INN or Proposed INN: CEFTRIAXONE Trade Name: Metoclopramide Product Name: Metoclopramide INN or Proposed INN: METOCLOPRAMIDE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Greece;Netherlands;Hungary;Norway;Poland;Italy;United Kingdom;Germany;Estonia | ||
| 791 | EUCTR2015-003335-35-IT (EUCTR) | 18/07/2016 | 28/02/2018 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) - SELECT-BEYOND | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 792 | ChiCTR-IPR-16008793 | 2016-07-15 | 2016-06-10 | A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis | A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis | Rheumatoid arthritis | experimental group:ZHENGQING FENGTONGNING sustained release tablets; control group:methotrexate;The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate; | The First Affiliated Hospital of Third Military Medical University | NULL | Recruiting | 18 | 75 | Both | experimental group:80; control group:80;The combined treatment group:80; | China | |
| 793 | EUCTR2015-003334-27-HU (EUCTR) | 13/07/2016 | 10/06/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 794 | EUCTR2015-003333-95-BG (EUCTR) | 13/07/2016 | 25/03/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 795 | EUCTR2015-003334-27-ES (EUCTR) | 08/07/2016 | 19/01/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy and ABT-494 30 mg Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Egypt;Hungary;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;New Zealand;Japan | ||
| 796 | EUCTR2016-001618-18-FR (EUCTR) | 08/07/2016 | 09/06/2016 | Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients | STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR | glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg | CHU Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | France | ||
| 797 | EUCTR2015-003376-75-HU (EUCTR) | 06/07/2016 | 09/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 798 | EUCTR2015-005307-83-PL (EUCTR) | 06/07/2016 | 01/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira) Product Code: LO4AB04 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 799 | EUCTR2015-003335-35-GR (EUCTR) | 05/07/2016 | 26/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 800 | EUCTR2015-003335-35-GB (EUCTR) | 05/07/2016 | 17/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 499 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 801 | EUCTR2015-003433-10-GB (EUCTR) | 05/07/2016 | 30/03/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 802 | NCT02683421 (ClinicalTrials.gov) | July 2016 | 22/1/2016 | Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging | Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging | Rheumatoid Arthritis | Drug: Tilmanocept | Navidea Biopharmaceuticals | NULL | Completed | 21 Years | N/A | All | 18 | Phase 1 | United States |
| 803 | NCT03106259 (ClinicalTrials.gov) | June 29, 2016 | 3/4/2017 | Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj | Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj | Rheumatoid Arthritis | Drug: FURESTEM-RA Inj. | Kang Stem Biotech Co., Ltd. | NULL | Active, not recruiting | 19 Years | 80 Years | All | 9 | Phase 1 | Korea, Republic of |
| 804 | EUCTR2015-003376-75-PL (EUCTR) | 28/06/2016 | 08/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand | ||
| 805 | EUCTR2015-003334-27-PL (EUCTR) | 28/06/2016 | 08/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 806 | EUCTR2015-003335-35-NO (EUCTR) | 27/06/2016 | 18/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 807 | EUCTR2015-003376-75-ES (EUCTR) | 23/06/2016 | 19/01/2016 | A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand | ||
| 808 | EUCTR2015-003334-27-GR (EUCTR) | 22/06/2016 | 13/05/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 809 | EUCTR2016-000064-42-CZ (EUCTR) | 21/06/2016 | 08/06/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 810 | EUCTR2015-002729-21-FI (EUCTR) | 21/06/2016 | 30/03/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 811 | NCT03333681 (ClinicalTrials.gov) | June 20, 2016 | 14/9/2017 | Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients | Evaluation of Mesenchymal Stem Cell Therapy Effects on the Cellular and Humoral Immune Responses and Additionally Study on the Effect of Chemokines in Homing of the Immune Cells in Refractory Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: Autologous mesenchymal stem cells | Mashhad University of Medical Sciences | NULL | Completed | 35 Years | 60 Years | Female | 15 | Phase 1 | NULL |
| 812 | EUCTR2015-003334-27-IE (EUCTR) | 17/06/2016 | 07/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;Serbia;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 813 | EUCTR2015-003376-75-PT (EUCTR) | 17/06/2016 | 09/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;European Union;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 814 | EUCTR2015-003334-27-LV (EUCTR) | 17/06/2016 | 08/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 815 | EUCTR2015-003334-27-PT (EUCTR) | 17/06/2016 | 09/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 816 | EUCTR2015-003332-13-BG (EUCTR) | 15/06/2016 | 25/03/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 817 | EUCTR2015-003334-27-GB (EUCTR) | 15/06/2016 | 09/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 818 | NCT03762824 (ClinicalTrials.gov) | June 14, 2016 | 3/12/2018 | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. | Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis | Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine | Region Skane | NULL | Completed | 18 Years | N/A | All | 300 | Phase 4 | NULL |
| 819 | EUCTR2015-003376-75-AT (EUCTR) | 10/06/2016 | 28/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 820 | EUCTR2015-003332-13-LT (EUCTR) | 10/06/2016 | 29/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 821 | EUCTR2015-003433-10-RO (EUCTR) | 09/06/2016 | 22/06/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | United States;Serbia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 822 | EUCTR2015-005308-27-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Colombia;Argentina;Czech Republic;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany | ||
| 823 | EUCTR2015-005307-83-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 824 | EUCTR2015-003433-10-IT (EUCTR) | 08/06/2016 | 27/02/2018 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | HEXAL AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 825 | EUCTR2015-003334-27-HR (EUCTR) | 08/06/2016 | 06/07/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 826 | EUCTR2015-001275-50-NL (EUCTR) | 08/06/2016 | 10/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 827 | EUCTR2015-003433-10-CZ (EUCTR) | 08/06/2016 | 30/03/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 828 | EUCTR2015-005308-27-CZ (EUCTR) | 07/06/2016 | 15/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Colombia;Czech Republic;Argentina;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany | ||
| 829 | EUCTR2015-003376-75-BE (EUCTR) | 07/06/2016 | 06/06/2016 | A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 830 | EUCTR2015-005307-83-CZ (EUCTR) | 07/06/2016 | 18/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 831 | EUCTR2015-002887-17-BE (EUCTR) | 07/06/2016 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;Netherlands;Japan;Korea, Republic of | ||
| 832 | EUCTR2015-003334-27-BE (EUCTR) | 07/06/2016 | 06/06/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia | ||
| 833 | EUCTR2015-003332-13-GR (EUCTR) | 06/06/2016 | 24/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 834 | EUCTR2015-003335-35-LV (EUCTR) | 03/06/2016 | 13/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 835 | NCT02797769 (ClinicalTrials.gov) | June 2, 2016 | 8/6/2016 | A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA) | Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases | Rheumatoid Arthritis | Drug: Other Biologics;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 48950 | NULL | |
| 836 | ChiCTR-INR-16009031 | 2016-06-01 | 2016-08-15 | Evaluation of the Effect of Huayu Qiangshen Tongbi Fomular Combined with MTX on Treating Rheumatoid Arthritis and Study of the mechanism through gut microbiomes | Evaluation of the Effect of Huayu Qiangshen Tongbi Fomular Combined with MTX on rheumatoid arthritis and Study of the mechanism through gut microbiomes | Rheumatoid Arthritis | the Treated Group:MTX 10-15mg po qw, and Huayu Qiangshen Tongbi Fang, po qd;the Controled Group:MTX 10-15mg po qw, and LEF 10mg po bid.; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | the Treated Group:100;the Controled Group:100; | China | |
| 837 | JPRN-UMIN000021929 | 2016/06/01 | 15/04/2016 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study | Rheumatoid arthritis | Discontinuation of infliximab | Chiba University | NULL | Complete: follow-up continuing | 18years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 838 | EUCTR2015-003335-35-PT (EUCTR) | 31/05/2016 | 30/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 839 | JPRN-jRCTs031180001 | 30/05/2016 | 12/06/2018 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT | Rheumatoid arthritis | Infliximab Withdrawal | Ikeda Kei | NULL | Complete | >= 18age old | Not applicable | Both | 200 | Phase 4 | Japan |
| 840 | EUCTR2015-003433-10-HU (EUCTR) | 26/05/2016 | 14/04/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 841 | EUCTR2015-003433-10-DE (EUCTR) | 25/05/2016 | 07/04/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 842 | EUCTR2015-003335-35-FR (EUCTR) | 24/05/2016 | 17/06/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 843 | EUCTR2016-002035-15-FI (EUCTR) | 20/05/2016 | 12/05/2016 | Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study | Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia | Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | Trade Name: Bicain spinal INN or Proposed INN: bupivacaine hydrochloride Other descriptive name: BUPIVACAINE HYDROCHLORIDE Trade Name: Propolipid INN or Proposed INN: propofol Other descriptive name: PROPOFOL | Helsinki University Central Hospital | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 4 | Finland | ||
| 844 | EUCTR2015-003335-35-SK (EUCTR) | 19/05/2016 | 22/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 845 | NCT02659150 (ClinicalTrials.gov) | May 18, 2016 | 21/12/2015 | Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis | A Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab | Massachusetts General Hospital | Brigham and Women's Hospital | Unknown status | 50 Years | 75 Years | Female | 21 | Phase 4 | NULL |
| 846 | EUCTR2015-003333-95-HU (EUCTR) | 18/05/2016 | 07/04/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 847 | NCT02792699 (ClinicalTrials.gov) | May 17, 2016 | 25/4/2016 | Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab | A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU) | Amgen | NULL | Completed | 18 Years | 80 Years | All | 311 | Phase 3 | United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada |
| 848 | EUCTR2014-004719-36-BG (EUCTR) | 14/05/2016 | 05/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Belarus;Turkey;Russian Federation;Bulgaria | ||
| 849 | EUCTR2015-003335-35-IE (EUCTR) | 13/05/2016 | 10/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 850 | EUCTR2015-003333-95-GR (EUCTR) | 12/05/2016 | 10/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 851 | NCT02780388 (ClinicalTrials.gov) | May 12, 2016 | 3/5/2016 | A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis | A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis | Adult Onset Rheumatoid Arthritis | Drug: VIB4920;Other: Placebo | Viela Bio | NULL | Completed | 18 Years | 70 Years | All | 57 | Phase 1 | United States;Poland |
| 852 | EUCTR2015-003332-13-CZ (EUCTR) | 11/05/2016 | 06/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Portugal;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 853 | EUCTR2015-003332-13-HR (EUCTR) | 11/05/2016 | 06/07/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 854 | EUCTR2015-003335-35-CZ (EUCTR) | 11/05/2016 | 15/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 855 | EUCTR2015-003333-95-CZ (EUCTR) | 11/05/2016 | 22/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 856 | EUCTR2015-003332-13-HU (EUCTR) | 10/05/2016 | 05/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Portugal;Belarus;Serbia;United States | ||
| 857 | JPRN-UMIN000022364 | 2016/05/10 | 20/05/2016 | Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis | Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis | Osteoprotic patients with rheumatoid arthritis | The selection criteria is based on which treatment each patient wants to take Minodronate group: oral intake 50mg per month Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast | Department of Orthopaedic Surgery Shinshu University School of Medicine | NULL | Complete: follow-up complete | 50years-old | 100years-old | Male and Female | 140 | Not applicable | Japan |
| 858 | EUCTR2015-003335-35-SE (EUCTR) | 10/05/2016 | 16/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 859 | EUCTR2015-003332-13-ES (EUCTR) | 09/05/2016 | 19/01/2016 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 860 | EUCTR2015-003433-10-ES (EUCTR) | 09/05/2016 | 22/07/2016 | ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis | GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial | rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB | Hexal, AG | NULL | Not Recruiting | Female: yes Male: yes | 308 | Phase 3 | Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of | ||
| 861 | EUCTR2015-003333-95-PT (EUCTR) | 06/05/2016 | 08/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 862 | EUCTR2015-003333-95-ES (EUCTR) | 06/05/2016 | 19/01/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand | ||
| 863 | EUCTR2015-003335-35-BE (EUCTR) | 04/05/2016 | 10/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 864 | EUCTR2015-003335-35-AT (EUCTR) | 04/05/2016 | 14/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Puerto Rico;Russian Federation;Hong Kong;United States;Portugal;Greece;Austria;Sweden;Latvia;Ireland;Brazil;Korea, Republic of;Slovakia;Slovenia;Chile;France;Bulgaria;Colombia;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Turkey;Belgium;European Union;Norway;Finland;Denmark;Mexico;Italy;Israel;Australia;Germany | ||
| 865 | EUCTR2015-002729-21-HU (EUCTR) | 04/05/2016 | 11/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 866 | EUCTR2015-005307-83-LT (EUCTR) | 04/05/2016 | 25/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 867 | EUCTR2015-003335-35-DK (EUCTR) | 03/05/2016 | 14/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 868 | EUCTR2015-003335-35-DE (EUCTR) | 03/05/2016 | 09/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 869 | NCT02760316 (ClinicalTrials.gov) | May 2, 2016 | 25/4/2016 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567. | A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control | Rheumatoid Arthritis | Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg | AstraZeneca | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 1 | Germany;United Kingdom |
| 870 | NCT02668640 (ClinicalTrials.gov) | May 1, 2016 | 27/1/2016 | Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China | Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study) | Rheumatoid Arthritis | Biological: Adalimumab | AbbVie | NULL | Completed | 18 Years | N/A | All | 55 | China | |
| 871 | NCT02665910 (ClinicalTrials.gov) | May 2016 | 24/1/2016 | Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients | A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA | Rheumatoid Arthritis | Drug: SHR0302;Drug: SHR0302 placebo comparator | Jiangsu HengRui Medicine Co., Ltd. | NULL | Not yet recruiting | 18 Years | 70 Years | Both | 48 | Phase 1 | China |
| 872 | NCT02762123 (ClinicalTrials.gov) | May 2016 | 3/5/2016 | A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates | Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | Both | 28 | Phase 1 | United States |
| 873 | EUCTR2015-003335-35-ES (EUCTR) | 29/04/2016 | 11/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 874 | EUCTR2015-003332-13-PL (EUCTR) | 26/04/2016 | 12/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 875 | EUCTR2015-002729-21-DE (EUCTR) | 25/04/2016 | 02/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 876 | EUCTR2015-003333-95-DE (EUCTR) | 25/04/2016 | 14/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 877 | EUCTR2015-003332-13-IE (EUCTR) | 22/04/2016 | 08/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 878 | EUCTR2015-003332-13-FI (EUCTR) | 22/04/2016 | 19/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 879 | EUCTR2015-003332-13-PT (EUCTR) | 22/04/2016 | 08/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 880 | EUCTR2015-003333-95-IE (EUCTR) | 22/04/2016 | 08/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 881 | EUCTR2015-002729-21-SK (EUCTR) | 22/04/2016 | 25/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 882 | EUCTR2015-003332-13-NO (EUCTR) | 22/04/2016 | 21/04/2016 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 883 | EUCTR2015-003333-95-AT (EUCTR) | 20/04/2016 | 12/04/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 884 | EUCTR2015-002887-17-NL (EUCTR) | 20/04/2016 | 22/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 885 | EUCTR2015-003332-13-LV (EUCTR) | 20/04/2016 | 12/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Puerto Rico;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland | ||
| 886 | EUCTR2015-003332-13-AT (EUCTR) | 20/04/2016 | 01/06/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Poland;Belgium;Brazil;Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 887 | EUCTR2015-003333-95-LV (EUCTR) | 20/04/2016 | 12/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 888 | EUCTR2014-004868-38-IT (EUCTR) | 16/04/2016 | 06/11/2020 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. - A study comparing the use of etanercept and methotrexate, used either alone or in combination, for m | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL Product Name: Enbrel Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP Product Name: methotrexate Product Code: [NA] INN or Proposed INN: METOTREXATO | AMGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy | ||
| 889 | EUCTR2015-003333-95-DK (EUCTR) | 15/04/2016 | 07/04/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 890 | EUCTR2015-003332-13-IT (EUCTR) | 15/04/2016 | 28/02/2018 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs - SELECT-NEXT | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: N.A. | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Japan;Colombia;Switzerland;Portugal;Serbia;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Barbados;Russian Federation;Chile;Israel | ||
| 891 | EUCTR2015-003332-13-DK (EUCTR) | 15/04/2016 | 07/04/2016 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 892 | EUCTR2015-003332-13-GB (EUCTR) | 14/04/2016 | 11/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 893 | EUCTR2015-003333-95-GB (EUCTR) | 14/04/2016 | 11/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 894 | EUCTR2015-003333-95-BE (EUCTR) | 13/04/2016 | 07/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 895 | EUCTR2015-003332-13-BE (EUCTR) | 13/04/2016 | 07/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 896 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 897 | EUCTR2015-003333-95-HR (EUCTR) | 05/04/2016 | 28/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 898 | NCT02770794 (ClinicalTrials.gov) | April 1, 2016 | 11/5/2016 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity | Arthritis, Rheumatoid | Drug: Infliximab | Chiba University | NULL | Completed | 18 Years | N/A | All | 211 | Phase 4 | Japan |
| 899 | NCT02722044 (ClinicalTrials.gov) | April 2016 | 23/3/2016 | Usability of an AI for M923 in Subjects With Moderate to Severe RA | An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: M923;Device: Autoinjector | Momenta Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 33 | Phase 3 | United States |
| 900 | NCT02715908 (ClinicalTrials.gov) | April 2016 | 17/3/2016 | A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX) | A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002 | Rheumatoid Arthritis | Drug: LBEC0101 | LG Life Sciences | NULL | Completed | 20 Years | 75 Years | All | 148 | Phase 3 | Korea, Republic of |
| 901 | EUCTR2015-002887-17-AT (EUCTR) | 29/03/2016 | 18/01/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142 Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 902 | NCT02573012 (ClinicalTrials.gov) | March 29, 2016 | 1/10/2015 | Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 314 | Phase 4 | France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey |
| 903 | EUCTR2015-002887-17-ES (EUCTR) | 28/03/2016 | 13/01/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 904 | NCT02679001 (ClinicalTrials.gov) | March 24, 2016 | 8/2/2016 | A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment. | A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT | Rheumatoid Arthritis | Drug: TNF inhibitor/TCZ | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 200 | Sweden | |
| 905 | NCT02720523 (ClinicalTrials.gov) | March 22, 2016 | 22/3/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Rheumatoid Arthritis | Drug: Placebo;Drug: Upadacitinib | AbbVie | NULL | Active, not recruiting | 18 Years | N/A | All | 197 | Phase 2/Phase 3 | Japan |
| 906 | NCT02682823 (ClinicalTrials.gov) | March 21, 2016 | 11/2/2016 | Tocilizumab Real-Life Human Factors (RLHFs) Validation Study | Tocilizumab Real-Life Human Factors Validation Study | Rheumatoid Arthritis | Device: AI-1000 G2;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 91 | Phase 4 | United States |
| 907 | NCT02706847 (ClinicalTrials.gov) | March 15, 2016 | 18/2/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Rheumatoid Arthritis | Drug: Upadacitinib;Drug: Placebo | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 499 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Latvia;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Argentina;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Denmark;Hong Kong;Italy;Mexico;Norway;Slovenia |
| 908 | NCT01961310 (ClinicalTrials.gov) | March 8, 2016 | 9/10/2013 | Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis | Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Plasma analysis for bacterial translocation;Biological: Stool analysis | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | N/A | All | 55 | France | |
| 909 | EUCTR2015-002523-26-HU (EUCTR) | 08/03/2016 | 13/11/2015 | Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal) | Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal) | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib Product Code: CP-690,55-10 | Arthritis Alapítvány | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Hungary | ||||
| 910 | EUCTR2014-004868-38-PT (EUCTR) | 07/03/2016 | 18/12/2015 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | France;United States;Portugal;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany | ||
| 911 | JPRN-UMIN000021492 | 2016/03/01 | 20/03/2016 | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. - Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients. | Rheumatoid arthritis | switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients. | Inoue Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 912 | NCT02652299 (ClinicalTrials.gov) | March 2016 | 15/11/2015 | Fibrocytes in Early and Longstanding Rheumatoid Arthritis | Fibrocytes in Early and Longstanding Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Synovial biopsy | Odense University Hospital | NULL | Completed | 18 Years | N/A | All | 60 | Denmark | |
| 913 | NCT02728934 (ClinicalTrials.gov) | February 25, 2016 | 31/3/2016 | Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis | Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab | Janssen Scientific Affairs, LLC | NULL | Completed | 18 Years | N/A | All | 1279 | United States | |
| 914 | EUCTR2015-002634-41-DE (EUCTR) | 25/02/2016 | 10/11/2015 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 915 | EUCTR2015-002924-17-BE (EUCTR) | 24/02/2016 | 27/01/2016 | A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis | A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol | Sun Pharma Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Belgium;Netherlands | ||
| 916 | EUCTR2015-002634-41-BG (EUCTR) | 24/02/2016 | 21/12/2015 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 917 | NCT02698657 (ClinicalTrials.gov) | February 23, 2016 | 10/2/2016 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate | A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis (RA) | Drug: ASP5094;Drug: Placebo | Astellas Pharma Global Development, Inc. | NULL | Completed | 18 Years | 65 Years | All | 30 | Phase 1 | United States;Poland |
| 918 | NCT02706873 (ClinicalTrials.gov) | February 23, 2016 | 18/2/2016 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo to Upadacitinib;Drug: Methotrexate;Drug: Placebo to Methotrexate;Drug: Upadacitinib | AbbVie | NULL | Completed | 18 Years | N/A | All | 1002 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands |
| 919 | EUCTR2012-002009-23-DE (EUCTR) | 22/02/2016 | 09/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 920 | NCT02638948 (ClinicalTrials.gov) | February 16, 2016 | 21/12/2015 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Drug: BMS-986142;Drug: Placebo;Drug: Methotrexate | Bristol-Myers Squibb | NULL | Completed | 18 Years | 120 Years | All | 508 | Phase 2 | United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium |
| 921 | NCT02321930 (ClinicalTrials.gov) | February 16, 2016 | 23/9/2014 | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: tofacitinib 5mg po bid | University of California, Los Angeles | NULL | Completed | 18 Years | N/A | All | 37 | Phase 4 | United States |
| 922 | EUCTR2015-000570-35-IT (EUCTR) | 10/02/2016 | 26/01/2021 | Prevention of re-onset of HBV infection in patients apparently cured affected by rheumatological diseases requiring finite duration treatments with drugs that impair the immune systems. | Prophylaxis of Hepatitis B reactivation in patients with HBV occult infection and rheumatological diseases candidates to immune suppressive treatments of finite duration. - Prophylaxis of OBI reactivation | Occult Hepatitis B virus Infection (OBI) in patients with rheumatologic diseases candidate to treatment a finite duration (less than 18 months) with potent immune suppressive drugs MedDRA version: 20.0;Level: HLT;Classification code 10037163;Term: Psoriatic arthropathies;System Organ Class: 100000004859 MedDRA version: 20.1;Classification code 10057212;Term: Hepatitis viral infections;System Organ Class: 100000004862 MedDRA version: 20.0;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: VIREAD - 245 MG 30 COMPRESSE RIVESTITE CON FILM IN FLACONE USO ORALE Product Name: VIREAD 30 CPR 245 MG Product Code: 35565011 | DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Italy | ||
| 923 | EUCTR2015-001275-50-RO (EUCTR) | 10/02/2016 | 22/02/2016 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy | ||
| 924 | EUCTR2014-004868-38-HU (EUCTR) | 09/02/2016 | 11/12/2015 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | Greece;Canada;Argentina;Czech Republic;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain | ||
| 925 | EUCTR2015-001275-50-HU (EUCTR) | 09/02/2016 | 04/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden | ||
| 926 | EUCTR2014-004868-38-BG (EUCTR) | 02/02/2016 | 22/12/2015 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany | ||
| 927 | NCT02683564 (ClinicalTrials.gov) | February 2016 | 9/2/2016 | BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study | A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study | Rheumatoid Arthritis | Drug: BOW015;Drug: Remicade | Epirus Biopharmaceuticals (Switzerland) GmbH | NULL | Not yet recruiting | 18 Years | 80 Years | Both | 548 | Phase 3 | NULL |
| 928 | NCT03355872 (ClinicalTrials.gov) | February 2016 | 22/11/2017 | A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs | A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs | Rheumatoid Arthritis | Drug: HLX01 | Shanghai Henlius Biotech | NULL | Completed | 18 Years | 65 Years | All | 194 | Phase 1/Phase 2 | NULL |
| 929 | EUCTR2015-002809-12-BG (EUCTR) | 27/01/2016 | 02/12/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India | ||
| 930 | EUCTR2014-004868-38-GR (EUCTR) | 26/01/2016 | 02/12/2015 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 3 | France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany | ||
| 931 | NCT02640612 (ClinicalTrials.gov) | January 22, 2016 | 18/12/2015 | Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis | Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab | Arthritis, Rheumatoid | Drug: BI 695501 | Boehringer Ingelheim | NULL | Completed | 18 Years | 80 Years | All | 430 | Phase 3 | United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine |
| 932 | EUCTR2015-002634-41-PL (EUCTR) | 20/01/2016 | 16/12/2015 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of | ||
| 933 | EUCTR2014-004868-38-ES (EUCTR) | 19/01/2016 | 13/01/2016 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 720 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany | ||
| 934 | JPRN-UMIN000018931 | 2016/01/17 | 07/09/2015 | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial - Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | 1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery. 100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery. | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 935 | EUCTR2014-000358-13-DE (EUCTR) | 14/01/2016 | 31/07/2015 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Trade Name: Zostavax® Product Name: Zostavax | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 936 | EUCTR2015-003332-13-SK (EUCTR) | 12/01/2016 | 04/11/2015 | A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 937 | EUCTR2014-004673-16-DE (EUCTR) | 12/01/2016 | 15/07/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland | ||
| 938 | EUCTR2014-004868-38-FR (EUCTR) | 12/01/2016 | 18/01/2016 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 720 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany | ||
| 939 | EUCTR2015-002634-41-HU (EUCTR) | 07/01/2016 | 16/10/2015 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 940 | EUCTR2012-002009-23-HU (EUCTR) | 07/01/2016 | 29/09/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 941 | NCT02636907 (ClinicalTrials.gov) | January 6, 2016 | 18/12/2015 | Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe | Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe | Arthritis, Rheumatoid | Drug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringe | Boehringer Ingelheim | NULL | Completed | 18 Years | 80 Years | All | 77 | Phase 2 | United States;Poland;Ukraine |
| 942 | NCT03855007 (ClinicalTrials.gov) | January 1, 2016 | 15/2/2019 | The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred | Qilu Hospital of Shandong University | NULL | Active, not recruiting | 16 Years | 90 Years | All | 200 | Phase 4 | China |
| 943 | NCT02762838 (ClinicalTrials.gov) | January 2016 | 4/4/2016 | Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acid | Biocad | NULL | Completed | 18 Years | 75 Years | All | 426 | Phase 3 | Belarus;India;Russian Federation |
| 944 | NCT02878161 (ClinicalTrials.gov) | January 2016 | 12/7/2016 | Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World | Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway | Rheumatoid Arthritis | Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary) | Fen Li | NULL | Enrolling by invitation | 18 Years | 75 Years | Both | 240 | Phase 4 | NULL |
| 945 | NCT02644499 (ClinicalTrials.gov) | December 31, 2015 | 30/12/2015 | Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis | Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Completed | 18 Years | N/A | All | 186 | Phase 4 | India |
| 946 | NCT02608112 (ClinicalTrials.gov) | December 31, 2015 | 16/11/2015 | Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year | Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 291 | France | |
| 947 | EUCTR2014-000352-29-HR (EUCTR) | 29/12/2015 | 01/02/2016 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 948 | EUCTR2015-002809-12-ES (EUCTR) | 23/12/2015 | 30/10/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 949 | EUCTR2014-004868-38-CZ (EUCTR) | 21/12/2015 | 03/12/2015 | A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis. | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 3 | Greece;Canada;Czech Republic;Argentina;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain | ||
| 950 | JPRN-jRCT2071200058 | 21/12/2015 | 25/11/2020 | Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects | A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study | Rheumatoid arthritis;D001172 | Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug | Yonemura Takuma | NULL | Complete | >= 20age old | < 45age old | Male | 130 | Phase 1 | Japan |
| 951 | EUCTR2015-001275-50-AT (EUCTR) | 20/12/2015 | 23/11/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden | ||
| 952 | EUCTR2015-004173-32-DK (EUCTR) | 18/12/2015 | 20/10/2015 | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study. | Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Department of Clinical Biochemestry, Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Denmark | ||
| 953 | EUCTR2015-003333-95-SK (EUCTR) | 18/12/2015 | 04/11/2015 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 954 | EUCTR2015-002634-41-ES (EUCTR) | 17/12/2015 | 30/10/2015 | Long-term study of BI695501 in patients with active rheumatoid arthritis | Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 955 | EUCTR2015-000665-30-DE (EUCTR) | 17/12/2015 | 14/07/2015 | Coherus Open-Label Safety Extension Study | An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES | Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 19.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214 | Coherus BioSciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 447 | Phase 3 | France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom | ||
| 956 | NCT02675426 (ClinicalTrials.gov) | December 17, 2015 | 11/12/2015 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Rheumatoid Arthritis | Drug: Placebo;Drug: Upadacitinib | AbbVie | NULL | Active, not recruiting | 18 Years | 99 Years | All | 661 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Brazil;Colombia;Czech Republic;Denmark;Israel;Netherlands;Norway;Serbia;Singapore |
| 957 | EUCTR2015-001275-50-IT (EUCTR) | 17/12/2015 | 05/11/2020 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis. | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive - ND | Early Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: [BMS-188667] INN or Proposed INN: ABATACEPT Other descriptive name: ND Trade Name: Methotrexate Ebewe Product Name: Methotrexate Product Code: [na] INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate Product Code: [na] INN or Proposed INN: METOTREXATO Other descriptive name: METHOTREXATE | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 958 | EUCTR2015-001275-50-ES (EUCTR) | 15/12/2015 | 10/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden | ||
| 959 | EUCTR2015-003334-27-SK (EUCTR) | 11/12/2015 | 04/11/2015 | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand | ||
| 960 | EUCTR2015-001275-50-SE (EUCTR) | 09/12/2015 | 04/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 961 | EUCTR2012-002009-23-GB (EUCTR) | 09/12/2015 | 07/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 962 | EUCTR2015-001275-50-FI (EUCTR) | 08/12/2015 | 08/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 963 | EUCTR2015-001275-50-GB (EUCTR) | 04/12/2015 | 26/11/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 964 | ChiCTR-IPR-15007368 | 2015-12-01 | 2015-11-09 | Clinical Research for the Effect of Chinese and Western Medicine on Treating Rheumatoid Arthritis | Comparative Study on the Influences of Gut Microbiota of Chinese and Western Medicine for Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | 1:HuaYuTongBiFang;2:HuaYuTongBiFang+MTX;3:ZhengQingFengTongNing Pills+MTX;4:Methotrexate; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Pending | 18 | 65 | Male | 1:96;2:96;3:96;4:96; | China | |
| 965 | EUCTR2015-001275-50-DE (EUCTR) | 01/12/2015 | 24/11/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 966 | NCT02629159 (ClinicalTrials.gov) | December 1, 2015 | 10/12/2015 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Rheumatoid Arthritis | Drug: Placebo for Adalimumab;Drug: Adalimumab;Drug: Placebo for Upadacitinib;Drug: Upadacitinib | AbbVie | NULL | Active, not recruiting | 18 Years | N/A | All | 1629 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands |
| 967 | NCT02837146 (ClinicalTrials.gov) | December 2015 | 7/7/2016 | Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis | Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA) | Rheumatoid Arthritis | Biological: Tocilizumab (TCZ);Drug: Methotrexate (MTX) | Maria Stoenoiu | NULL | Recruiting | 18 Years | 75 Years | Both | 45 | Phase 3 | Belgium |
| 968 | NCT02944799 (ClinicalTrials.gov) | December 2015 | 27/6/2016 | Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis | Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass | Rheumatoid Arthritis;Osteoporosis | Drug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin D | University of Aarhus | NULL | Active, not recruiting | 18 Years | N/A | All | 69 | Phase 2 | Denmark |
| 969 | EUCTR2015-001275-50-FR (EUCTR) | 30/11/2015 | 04/12/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 970 | EUCTR2015-002809-12-CZ (EUCTR) | 27/11/2015 | 02/10/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 971 | EUCTR2012-002009-23-BG (EUCTR) | 25/11/2015 | 15/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 972 | ChiCTR-IOR-15007418 | 2015-11-20 | 2015-11-19 | Clinical Observation on Treatment of Active Refractory Rheumatoid Arthritis with Huayu Tongbi Decoction | Clinical Observation on Treatment of Active Refractory Rheumatoid Arthritis with Huayu Tongbi Decoction | Rheumatoid arthritis | treatment group:Huayu Tongbi Decoction combined with MTX;controlled group:MTX combined with MTX; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Recruiting | Male | treatment group:30;controlled group:30; | China | |||
| 973 | EUCTR2012-002009-23-ES (EUCTR) | 20/11/2015 | 15/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 974 | ChiCTR-IPR-15007415 | 2015-11-20 | 2015-11-19 | Study of Sinomenine Hydrochloride in the treatment of rheumatoid arthritis | Study of Sinomenine Hydrochloride in the treatment of rheumatoid arthritis | Rheumatoid arthritis | treatment group:sinomenine hydrochloride combined with MTX;controlled group:LEF combined with MTX; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Recruiting | Both | treatment group:25;controlled group:25; | China | |||
| 975 | NCT02557100 (ClinicalTrials.gov) | November 19, 2015 | 4/9/2015 | Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis | A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 80 | Phase 4 | United States;Canada;Mexico;Algeria |
| 976 | EUCTR2013-002777-22-IT (EUCTR) | 19/11/2015 | 04/12/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 4 | France;Hungary;Spain;Denmark;Germany;United Kingdom;Japan;Italy | ||
| 977 | NCT03172325 (ClinicalTrials.gov) | November 18, 2015 | 24/5/2017 | Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA | A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RA | Active Rheumatoid Arthritis | Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone | Cinnagen | NULL | Completed | 18 Years | 75 Years | All | 136 | Phase 3 | Iran, Islamic Republic of |
| 978 | NCT02512575 (ClinicalTrials.gov) | November 18, 2015 | 6/7/2015 | A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567. | A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects. | Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis | Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Male | 72 | Phase 1 | Germany |
| 979 | EUCTR2015-002809-12-HU (EUCTR) | 17/11/2015 | 26/08/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India | ||
| 980 | EUCTR2015-002809-12-LV (EUCTR) | 17/11/2015 | 21/09/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 981 | EUCTR2014-004673-16-FR (EUCTR) | 16/11/2015 | 05/08/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland | ||
| 982 | EUCTR2013-000337-13-PT (EUCTR) | 13/11/2015 | 11/11/2015 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Serbia;Portugal;Germany | ||
| 983 | EUCTR2012-002009-23-CZ (EUCTR) | 13/11/2015 | 30/09/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 984 | EUCTR2015-002924-17-NL (EUCTR) | 12/11/2015 | 06/10/2015 | A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis | A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol | Sun Pharma Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Netherlands | ||
| 985 | EUCTR2012-003876-38-PL (EUCTR) | 10/11/2015 | 16/11/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 986 | EUCTR2012-002009-23-LT (EUCTR) | 06/11/2015 | 02/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 987 | NCT02780323 (ClinicalTrials.gov) | November 2, 2015 | 19/5/2016 | Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis | A Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CELBESTA®;Drug: CELEBREX®;Drug: CELEBREX® placebo;Drug: CELBESTA® placebo | Dong-A ST Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 119 | Phase 4 | Korea, Republic of |
| 988 | JPRN-UMIN000018848 | 2015/11/01 | 29/08/2015 | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Rheumatoid arthritis | control: continue the present treatment intervention: reduce the dosage of methotrexate by half every 3 months and discontinue intervention: extend the interval of biologics to one and a half times every 3 months and discontinue | Keio University Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 900 | Not applicable | Japan |
| 989 | NCT02723760 (ClinicalTrials.gov) | November 2015 | 10/3/2016 | 99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients | Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 99mTc-3PRGD2 | First Affiliated Hospital of Fujian Medical University | NULL | Recruiting | 20 Years | 70 Years | Both | 40 | Phase 0 | China |
| 990 | NCT02534896 (ClinicalTrials.gov) | November 2015 | 25/8/2015 | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis | Drug: Treatment I;Drug: Treatment II;Drug: Treatment III | Sun Pharmaceutical Industries Limited | NULL | Terminated | 18 Years | 90 Years | All | 150 | Phase 3 | Belgium;Netherlands |
| 991 | ChiCTR-OPB-15007284 | 2015-10-30 | 2015-10-26 | Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patients | Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patients | Rheumatoid Arthritis | RA group1:Doxycycline;RA group 2:Placebo; | Hong Kong Baptist University | NULL | Recruiting | 18 | 80 | Both | RA group1:20;RA group 2:20; | China | |
| 992 | EUCTR2012-002009-23-SK (EUCTR) | 27/10/2015 | 07/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 993 | EUCTR2014-003453-34-PL (EUCTR) | 26/10/2015 | 29/09/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Poland;South Africa;Bulgaria;Germany;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina | ||
| 994 | EUCTR2012-002009-23-LV (EUCTR) | 23/10/2015 | 08/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Latvia;Germany | ||
| 995 | EUCTR2012-002009-23-PL (EUCTR) | 22/10/2015 | 08/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 996 | EUCTR2015-001275-50-CZ (EUCTR) | 21/10/2015 | 29/09/2015 | Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive | Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden | ||
| 997 | EUCTR2014-000352-29-BG (EUCTR) | 21/10/2015 | 31/08/2015 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 998 | EUCTR2015-001246-28-BE (EUCTR) | 19/10/2015 | 23/07/2015 | Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) | Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: RoActemra | Cliniques Universitaires Saint-Luc, Université catholique de Louvain | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 999 | EUCTR2014-003307-30-GB (EUCTR) | 16/10/2015 | 25/08/2015 | Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Celltech, UK Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Slovakia;Russian Federation;United Kingdom | ||
| 1000 | EUCTR2014-000110-61-DE (EUCTR) | 15/10/2015 | 04/05/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1001 | EUCTR2015-000581-58-CZ (EUCTR) | 14/10/2015 | 16/06/2015 | A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Revmatologicky ustav Praha | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Czech Republic | ||
| 1002 | NCT02534311 (ClinicalTrials.gov) | October 13, 2015 | 25/8/2015 | A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28) | Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 60 | Phase 4 | Slovakia |
| 1003 | EUCTR2012-002009-23-EE (EUCTR) | 12/10/2015 | 06/10/2015 | Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis | A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA | Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 366 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia | ||
| 1004 | JPRN-UMIN000020833 | 2015/10/09 | 01/02/2016 | The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. | The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. - The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis. | Rheumatoid arthritis | Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks. Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks. If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA. | Zenjinkai Shimin-no-mori Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 240 | Not selected | Japan |
| 1005 | EUCTR2014-003453-34-DE (EUCTR) | 08/10/2015 | 26/05/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. - | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1006 | EUCTR2014-003453-34-IT (EUCTR) | 05/10/2015 | 19/01/2021 | Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. - - | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 Other descriptive name: Anticorpo monoclonale anti GM-CSF umano | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Czechia;Taiwan;Estonia;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany | ||
| 1007 | NCT02778789 (ClinicalTrials.gov) | October 2015 | 16/5/2016 | Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers | Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers. | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: TNF-alpha Inhibitor | University of Erlangen-Nürnberg Medical School | NULL | Completed | 18 Years | N/A | All | 66 | Germany | |
| 1008 | NCT02882087 (ClinicalTrials.gov) | October 2015 | 24/8/2016 | A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis | A Phase II, Placebo-Controlled, Multicenter, Dynamic Randomized, Double Blind Trial of RC18, a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Inadequate Response of TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis | Moderate and Severe Rheumatoid Arthritis | Drug: Placebo plus MTX;Drug: RC18 160 mg plus MTX | RemeGen | NULL | Terminated | 18 Years | 65 Years | All | 60 | Phase 2 | China |
| 1009 | EUCTR2015-003638-28-DK (EUCTR) | 30/09/2015 | 28/08/2015 | Treatment of osteoporosis in patients with rheumatoid arthritis. | ALOSTRAAlendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA | Rheumatoid arthritis and osteoporosis MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Alendronat Teva INN or Proposed INN: Alendronic Acid Other descriptive name: ALENDRONIC ACID | Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Denmark | ||
| 1010 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 1011 | EUCTR2014-003453-34-CZ (EUCTR) | 16/09/2015 | 23/06/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1012 | EUCTR2014-003453-34-ES (EUCTR) | 03/09/2015 | 03/07/2015 | Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Taiwan;Estonia;Spain;Ukraine;Russian Federation;Chile;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany | ||
| 1013 | NCT02504268 (ClinicalTrials.gov) | September 3, 2015 | 20/7/2015 | Effects of Abatacept in Patients With Early Rheumatoid Arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 994 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates |
| 1014 | NCT05116228 (ClinicalTrials.gov) | September 1, 2015 | 21/3/2018 | Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission | Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study | Rheumatoid Arthritis;Remission | Drug: 500mg RTX Group;Drug: 1000mg RTX Group | Medical University of Vienna | NULL | Terminated | 18 Years | N/A | All | 21 | Phase 4 | Austria |
| 1015 | NCT02748785 (ClinicalTrials.gov) | September 2015 | 8/9/2015 | MTX Discontinuation and Vaccine Response | Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial | Arthritis, Rheumatoid | Drug: Methotrexate;Biological: Seasonal Influenza vaccine | Seoul National University Hospital | NULL | Completed | 18 Years | N/A | Both | 277 | Phase 4 | Korea, Republic of |
| 1016 | NCT02535832 (ClinicalTrials.gov) | September 2015 | 24/8/2015 | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis;Insulin Resistance | Drug: Pioglitazone;Drug: Placebo | Ohio State University | NULL | Recruiting | 35 Years | 65 Years | All | 36 | Phase 1 | United States |
| 1017 | NCT02553018 (ClinicalTrials.gov) | September 2015 | 16/9/2015 | Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe | A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection. | Arthritis, Rheumatoid | Drug: Methotrexate | Nordic Pharma SAS | NULL | Completed | 18 Years | N/A | All | 278 | Phase 3 | France |
| 1018 | NCT02565810 (ClinicalTrials.gov) | September 2015 | 23/9/2015 | An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab PFS and Pen | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 55 Years | All | 49 | Phase 2 | Poland |
| 1019 | JPRN-UMIN000027241 | 2015/08/31 | 03/05/2017 | the change of IMT of carotide artery in RA with treatment of tocilizumab | the change of IMT of carotide artery in RA with treatment of tocilizumab - the change of IMT of carotide artery in RA with treatment of tocilizumab | rheumatoid arthritis | tofacitinib | hiroshima clinic | NULL | Complete: follow-up complete | 18years-old | 80years-old | Male and Female | 50 | Not applicable | Japan |
| 1020 | EUCTR2014-003453-34-GB (EUCTR) | 24/08/2015 | 13/07/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;South Africa;Bulgaria;Germany | ||
| 1021 | EUCTR2013-003177-99-AT (EUCTR) | 17/08/2015 | 07/05/2015 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1022 | EUCTR2013-003177-99-FI (EUCTR) | 12/08/2015 | 12/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1023 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 1024 | NCT02481180 (ClinicalTrials.gov) | July 31, 2015 | 18/6/2015 | Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis) | An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis) | Rheumatoid Arthritis | Drug: T0001;Drug: Enbrel | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | NULL | Terminated | 18 Years | 65 Years | All | 36 | Phase 1 | China |
| 1025 | EUCTR2015-000665-30-GB (EUCTR) | 30/07/2015 | 20/05/2015 | Coherus Open-Label Safety Extension Study | An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES | Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214 | Coherus BioSciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 447 | Phase 3 | France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom | ||
| 1026 | EUCTR2012-003876-38-HU (EUCTR) | 28/07/2015 | 22/05/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 1027 | EUCTR2014-004673-16-IT (EUCTR) | 27/07/2015 | 04/06/2021 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy | ||
| 1028 | EUCTR2015-000665-30-IT (EUCTR) | 27/07/2015 | 28/02/2018 | Coherus Open-Label Safety Extension Study | An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES | Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: etanercept Product Code: CHS-0214 INN or Proposed INN: ETANERCEPT Other descriptive name: ETANERCEPT | COHERUS BIOSCIENCES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 447 | Phase 3 | France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;United Kingdom;Italy | ||
| 1029 | EUCTR2015-000665-30-ES (EUCTR) | 24/07/2015 | 01/06/2015 | Coherus Open-Label Safety Extension Study | An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES | Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214 | Coherus BioSciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 447 | Phase 3 | France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom | ||
| 1030 | EUCTR2014-003453-34-HU (EUCTR) | 23/07/2015 | 27/05/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1031 | NCT02504671 (ClinicalTrials.gov) | July 23, 2015 | 20/7/2015 | Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 222 | Phase 2 | Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 1032 | EUCTR2012-002535-28-ES (EUCTR) | 22/07/2015 | 10/07/2015 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 1033 | EUCTR2012-003876-38-DE (EUCTR) | 21/07/2015 | 29/04/2015 | Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past | A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT | Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Hexal AG (a Sandoz company) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Poland;Germany | ||
| 1034 | EUCTR2015-000833-64-FR (EUCTR) | 17/07/2015 | 02/07/2015 | N/A | N/A | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ORENCIA Trade Name: MABTHERA Trade Name: ROACTEMRA | CHU Amiens-Picardie | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | France | ||
| 1035 | EUCTR2014-003034-42-BG (EUCTR) | 15/07/2015 | 11/05/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 501 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1036 | EUCTR2014-003034-42-BE (EUCTR) | 13/07/2015 | 18/05/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 2 | Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1037 | EUCTR2014-003033-26-CZ (EUCTR) | 08/07/2015 | 05/12/2014 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1038 | EUCTR2014-000110-61-ES (EUCTR) | 06/07/2015 | 01/06/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1039 | NCT02242474 (ClinicalTrials.gov) | July 2015 | 15/9/2014 | Anti-TNFa Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis | Prospective Randomized Multicentric Trial on Anti-TNFa Treatment and Infection Risk in the Perioperative Period During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Anti-TNF suspended perioperatively;Drug: Anti-TNFa continued perioperatively | CHU de Quebec-Universite Laval | NULL | Unknown status | 18 Years | N/A | All | 660 | Phase 4 | Canada |
| 1040 | NCT02518620 (ClinicalTrials.gov) | July 2015 | 6/8/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061 | Rheumatoid Arthritis | Biological: ALX-0061 | Ablynx | NULL | Completed | 18 Years | 74 Years | All | 406 | Phase 2 | Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of |
| 1041 | NCT02598466 (ClinicalTrials.gov) | July 2015 | 4/11/2015 | Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa | Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Hexor, South Africa | Completed | 18 Years | N/A | Both | 69 | N/A | NULL |
| 1042 | NCT02531178 (ClinicalTrials.gov) | July 2015 | 14/7/2015 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257 | Rheumatoid Arthritis | Biological: ABBV-257;Biological: Placebo | AbbVie | NULL | Completed | 18 Years | 75 Years | Both | 8 | Phase 1 | Germany |
| 1043 | EUCTR2014-003034-42-DE (EUCTR) | 29/06/2015 | 18/03/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 2 | Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1044 | NCT02480153 (ClinicalTrials.gov) | June 25, 2015 | 19/6/2015 | A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Biological: PF-06410293;Biological: Adalimumab | Pfizer | NULL | Completed | 18 Years | N/A | All | 597 | Phase 3 | United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic |
| 1045 | EUCTR2014-003012-36-BG (EUCTR) | 19/06/2015 | 12/03/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1046 | EUCTR2014-003034-42-ES (EUCTR) | 19/06/2015 | 14/04/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 2 | Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1047 | EUCTR2014-003453-34-EE (EUCTR) | 18/06/2015 | 14/05/2015 | Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate. | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1048 | EUCTR2014-003012-36-CZ (EUCTR) | 10/06/2015 | 05/01/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1049 | NCT02405780 (ClinicalTrials.gov) | June 10, 2015 | 17/3/2015 | A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 645 | Phase 3 | United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic |
| 1050 | EUCTR2014-000358-13-HR (EUCTR) | 08/06/2015 | 10/11/2015 | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1051 | EUCTR2014-001471-31-DE (EUCTR) | 02/06/2015 | 04/02/2015 | This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963. | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1052 | EUCTR2015-000538-31-DE (EUCTR) | 01/06/2015 | 07/04/2015 | Application into the joint of opioids in chronic arthritis of the knee joint | NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint | chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Morphine Hexal INN or Proposed INN: Morphinsulfat Other descriptive name: MORPHINE SULFATE Trade Name: Triam 40 mg Lichtenstein INN or Proposed INN: TRIAMCINOLONACETONID Other descriptive name: TRIAMCINOLONACETONID EP | Charité University medicine Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 1053 | JPRN-UMIN000017495 | 2015/06/01 | 26/11/2015 | Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab | Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab - Methotraxate and Adalimumab study, to Space and TapEr for Rheumatoid arthritis patients at maintenance period (MASTER study) | rheumatoid arthritis(RA) | dose maintain group: no change of treatment MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped. ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped. | Keio University School of Medicine, Japan. | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 75 | Not selected | Japan |
| 1054 | EUCTR2014-003012-36-ES (EUCTR) | 27/05/2015 | 02/02/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1055 | EUCTR2010-021184-32-BG (EUCTR) | 27/05/2015 | 14/04/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 1056 | EUCTR2014-003012-36-DE (EUCTR) | 21/05/2015 | 29/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1057 | EUCTR2014-003033-26-DE (EUCTR) | 21/05/2015 | 18/12/2014 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1058 | NCT02402686 (ClinicalTrials.gov) | May 20, 2015 | 25/3/2015 | Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA) | Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 353 | Hungary | |
| 1059 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1060 | JPRN-UMIN000017440 | 2015/05/18 | 07/05/2015 | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study | Rheumatoid arthritis | for 3 months Tofacitinib 5mg BID everyday for 3 months Tofacitinib 5mg BID everyday for 3 months Methotrexate6mg-16mg/week | Graduate School of Medicine and School of Medicine, Chiba Universitythe department of allergy and clinical immunology | NULL | Complete: follow-up complete | 18years-old | 90years-old | Male and Female | 134 | Phase 4 | Japan |
| 1061 | EUCTR2013-004019-37-DK (EUCTR) | 13/05/2015 | 24/02/2015 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 1062 | EUCTR2014-000110-61-CZ (EUCTR) | 11/05/2015 | 04/05/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru | ||
| 1063 | EUCTR2014-003034-42-HU (EUCTR) | 08/05/2015 | 03/03/2015 | An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis | A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061 | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 2 | Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1064 | EUCTR2013-004569-16-DE (EUCTR) | 07/05/2015 | 26/11/2014 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy | ||
| 1065 | EUCTR2011-004720-35-NO (EUCTR) | 04/05/2015 | 26/01/2015 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 1066 | JPRN-UMIN000024143 | 2015/05/01 | 23/09/2016 | efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis | efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis - efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis | atherosclerosis efficacy of tofacitinib in RA | RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2) | hiroshima clinic | NULL | Complete: follow-up continuing | 18years-old | 75years-old | Male and Female | 50 | Phase 4 | Japan |
| 1067 | NCT02566967 (ClinicalTrials.gov) | May 2015 | 1/10/2015 | An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective | An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target | Rheumatoid Arthritis | Drug: tofacitinib | Norman B. Gaylis, MD | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 1068 | NCT02456844 (ClinicalTrials.gov) | May 2015 | 27/5/2015 | Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients | Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects | Rheumatoid Arthritis | Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142;Drug: Methotrexate, Leucovorin and BMS-986142 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | Both | 24 | Phase 1 | NULL |
| 1069 | NCT02460393 (ClinicalTrials.gov) | May 2015 | 18/1/2015 | A Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects | A Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy Subjects | Rheumatoid Arthritis | Drug: Humanized TNFa monoclonal antibody;Other: placebo | Shenyang Sunshine Pharmaceutical Co., LTD. | NULL | Completed | 18 Years | 45 Years | All | 72 | Phase 1 | China |
| 1070 | EUCTR2014-002945-23-ES (EUCTR) | 30/04/2015 | 09/02/2015 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom | ||
| 1071 | EUCTR2013-004569-16-GR (EUCTR) | 30/04/2015 | 29/01/2015 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany | ||
| 1072 | EUCTR2014-003033-26-BG (EUCTR) | 29/04/2015 | 19/02/2015 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Serbia;United States;Spain;Czech Republic;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1073 | EUCTR2014-001471-31-BG (EUCTR) | 29/04/2015 | 21/04/2015 | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1074 | EUCTR2010-021184-32-PL (EUCTR) | 21/04/2015 | 06/02/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 1075 | EUCTR2014-003307-30-SK (EUCTR) | 16/04/2015 | 02/02/2015 | Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BUMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Celltech, UK Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of | ||
| 1076 | EUCTR2014-003307-30-HU (EUCTR) | 16/04/2015 | 22/01/2015 | Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Celltech, UK Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of | ||
| 1077 | NCT02393378 (ClinicalTrials.gov) | April 8, 2015 | 15/3/2015 | Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid | Takeda | NULL | Terminated | 18 Years | N/A | All | 7 | Phase 2 | Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic |
| 1078 | EUCTR2014-001471-31-RO (EUCTR) | 08/04/2015 | 05/10/2015 | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Australia;Bulgaria;Germany;New Zealand | ||
| 1079 | EUCTR2014-002541-22-DE (EUCTR) | 02/04/2015 | 09/12/2014 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of | ||
| 1080 | JPRN-UMIN000016606 | 2015/04/01 | 01/04/2015 | Efficacy and safety of electroporation and MTX combination therapy for the patients with RA | Efficacy and safety of electroporation and MTX combination therapy for the patients with RA - Combination therapy of electroporation and MTX for the patients with RA | rheumatoid arthritis | * Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US). * Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electroporation for four angles with US gel. * Condition of electroporation is 50V/cm 250ms 4puluse. * Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline. * Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US). * Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. * Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline. | Osaka City University Medical School, Department of Orthopedic Surgery | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Phase 2 | Japan |
| 1081 | NCT02387762 (ClinicalTrials.gov) | April 2015 | 1/3/2015 | ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate | A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate | Rheumatoid Arthritis | Drug: acalabrutinib;Drug: Placebo | Acerta Pharma BV | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 2 | United States |
| 1082 | NCT02433340 (ClinicalTrials.gov) | April 2015 | 2/4/2015 | Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study | Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis | Drug: ABT-122 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 158 | Phase 2 | Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey |
| 1083 | NCT02499315 (ClinicalTrials.gov) | April 2015 | 10/4/2015 | Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 357;Drug: Placebo | Amgen | NULL | Terminated | 25 Years | 70 Years | Female | 32 | Phase 1 | United States |
| 1084 | NCT02378506 (ClinicalTrials.gov) | April 2015 | 13/2/2015 | Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects | A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 188 | Phase 3 | Bulgaria;Croatia;Germany;Greece;Hungary;Poland;Serbia;Slovakia;South Africa;Russian Federation |
| 1085 | NCT02800811 (ClinicalTrials.gov) | April 2015 | 20/5/2016 | Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104 | Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects | Rheumatoid Arthritis;Complication of Transplant | Drug: FR104;Drug: Placebo | OSE Immunotherapeutics | NULL | Completed | 18 Years | 60 Years | Both | 64 | Phase 1 | Belgium |
| 1086 | NCT02423538 (ClinicalTrials.gov) | April 2015 | 7/4/2015 | First-in-Human Single Ascending Dose of SHR0302 | A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302;Drug: SHR0302 placebo comparator | Jiangsu HengRui Medicine Co., Ltd. | NULL | Active, not recruiting | 18 Years | 45 Years | Both | 64 | Phase 1 | China |
| 1087 | EUCTR2014-003307-30-CZ (EUCTR) | 31/03/2015 | 03/02/2015 | Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Celltech, UK Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of | ||
| 1088 | ChiCTR-IPR-15006107 | 2015-03-30 | 2015-03-18 | The clinical trial of tolerance of Ginsenoside compound K | To study the pharmacokinetics and tolerance of Ginsenoside compound K tablet in healthy volunteers after multiple dosing administration | rheumatoid arthritis | three groups:Ginsenoside compound K is administrated after single dose or multiple doses; | Institute of Clinical Pharmacology, Central South University | NULL | Pending | 18 | 45 | Male | three groups:12; | I (Phase 1 study) | China |
| 1089 | JPRN-UMIN000016950 | 2015/03/27 | 03/04/2015 | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept - Clinical outcome in patients with RA switched to TNF blocker after tocilizumab or abatacept | rheumatoid arthritis | Infliximab or adalimumab or golimumab | Osaka Medical College | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 1090 | EUCTR2015-000089-72-IT (EUCTR) | 26/03/2015 | 06/02/2015 | abatacept in obese and overweight RA patiens | FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE | MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ORENCIA Product Name: Orencia abatacept | Policlinico Gemelli-CIC- UCSC | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Italy | ||
| 1091 | EUCTR2010-021184-32-GB (EUCTR) | 25/03/2015 | 12/06/2015 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 1092 | NCT02486302 (ClinicalTrials.gov) | March 24, 2015 | 28/6/2015 | A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. | A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT | Rheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque Psoriasis | Drug: Etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 1534 | Germany | |
| 1093 | EUCTR2014-003012-36-BE (EUCTR) | 23/03/2015 | 18/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1094 | EUCTR2014-003033-26-BE (EUCTR) | 23/03/2015 | 25/11/2014 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1095 | EUCTR2014-001471-31-HU (EUCTR) | 23/03/2015 | 23/01/2015 | This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963. | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1096 | EUCTR2013-004569-16-BG (EUCTR) | 18/03/2015 | 05/01/2015 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany | ||
| 1097 | EUCTR2014-002541-22-GB (EUCTR) | 18/03/2015 | 09/01/2015 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of | |||
| 1098 | EUCTR2014-000352-29-FR (EUCTR) | 16/03/2015 | 18/06/2015 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1099 | EUCTR2013-004569-16-HR (EUCTR) | 16/03/2015 | 29/04/2015 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany | ||
| 1100 | EUCTR2012-001176-10-BG (EUCTR) | 16/03/2015 | 04/11/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 1101 | EUCTR2014-003012-36-HU (EUCTR) | 10/03/2015 | 30/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1102 | EUCTR2013-005524-42-NL (EUCTR) | 10/03/2015 | 27/03/2014 | STAtins to Prevent Rheumatoid Arthritis (STAPRA) | Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial - STAtins to Prevent Rheumatoid Arthritis (STAPRA) | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039080;Term: Rheumatoid factor positive;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Atorvastatin Product Name: Atorvastatin Product Code: C10AA05 INN or Proposed INN: ATORVASTATIN | Reade | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 4 | Netherlands | ||
| 1103 | NCT02304354 (ClinicalTrials.gov) | March 9, 2015 | 4/11/2014 | Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX) | Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX) | Rheumatoid Arthritis | Drug: Rituximab | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | France |
| 1104 | EUCTR2014-001471-31-CZ (EUCTR) | 04/03/2015 | 27/01/2015 | This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963. | Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT) | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1105 | EUCTR2014-004472-35-NL (EUCTR) | 02/03/2015 | 01/12/2014 | TREAT EARLY ARTHRALGIA TO REVERSE OR LIMIT IMPENDING EXACERBATION TO RHEUMATOID ARTHRITIS | TREAT EARLY ARTHRALGIA TO REVERSE OR LIMIT IMPENDING EXACERBATION TO RHEUMATOID ARTHRITIS | Arthralgia of hands or feet of patients that are suspect to progress to reumatoid arthritis according to the treating rheumatologist and because of subclinical inflammation on MRI of hands and feet (Clinical Suspect Artralgia CSA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexaat Product Name: Methotrexaat Product Code: L04AX03 INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methylprednisolone Product Name: Methylprednisolone Product Code: H02AB04 INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE ACETATE | Leiden University medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 2 | Netherlands | ||
| 1106 | JPRN-UMIN000015433 | 2015/03/01 | 01/11/2014 | Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients | Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients - Safety study of MTX once daily administration in RA patients | rheumatoid arthritis | methotrexate | Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 35 | Not selected | Japan |
| 1107 | NCT02414984 (ClinicalTrials.gov) | March 2015 | 8/4/2015 | Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab | Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia | Rheumatoid Arthritis | Biological: Golimumab | Janssen-Cilag, S.A. | NULL | Terminated | 18 Years | N/A | All | 37 | N/A | Colombia |
| 1108 | NCT02287922 (ClinicalTrials.gov) | March 2015 | 5/11/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate | Rheumatoid Arthritis | Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab | Ablynx | NULL | Completed | 18 Years | 74 Years | All | 251 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of |
| 1109 | NCT02620189 (ClinicalTrials.gov) | March 2015 | 12/10/2015 | Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa | A Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa Therapies | Rheumatoid Arthritis | Drug: Anti-TNF Biologics Therapy | Queen Mary University of London | NULL | Completed | 18 Years | N/A | All | 60 | United Kingdom | |
| 1110 | EUCTR2013-004148-49-FR (EUCTR) | 23/02/2015 | 18/06/2015 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 1111 | NCT02638259 (ClinicalTrials.gov) | February 21, 2015 | 16/12/2015 | Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: GP2015 | Sandoz | NULL | Completed | 18 Years | N/A | All | 376 | Phase 3 | United States;Bulgaria;Czechia;Estonia;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Czech Republic |
| 1112 | EUCTR2014-003033-26-ES (EUCTR) | 20/02/2015 | 07/01/2015 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1113 | NCT02373813 (ClinicalTrials.gov) | February 20, 2015 | 12/1/2015 | Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission | A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: etanercept pre-filled syringe subcutaneous injection;Drug: Oral methotrexate;Drug: Placebo for etanercept subcutaneous injection;Drug: Placebo for methotrexate;Dietary Supplement: Folic acid (non-investigational product) | Amgen | NULL | Completed | 18 Years | N/A | All | 371 | Phase 3 | United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic |
| 1114 | EUCTR2013-002805-76-BG (EUCTR) | 20/02/2015 | 10/10/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose,efficacy and safety of 3 doses of namilumab combined with methotrexatein subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom | ||
| 1115 | EUCTR2014-002945-23-CZ (EUCTR) | 18/02/2015 | 21/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Estonia;Czech Republic;Spain;Russian Federation;United Kingdom | ||
| 1116 | EUCTR2014-002945-23-GB (EUCTR) | 18/02/2015 | 04/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Czech Republic;Spain;Russian Federation;United Kingdom | ||
| 1117 | EUCTR2014-001114-26-SE (EUCTR) | 18/02/2015 | 26/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1118 | EUCTR2014-003033-26-HU (EUCTR) | 17/02/2015 | 26/11/2014 | A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061 | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 1119 | EUCTR2014-002541-22-ES (EUCTR) | 16/02/2015 | 22/12/2014 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of | ||
| 1120 | EUCTR2014-001114-26-NL (EUCTR) | 13/02/2015 | 24/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden | ||
| 1121 | EUCTR2014-002541-22-HU (EUCTR) | 11/02/2015 | 15/12/2014 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of | ||
| 1122 | EUCTR2013-005418-37-DE (EUCTR) | 05/02/2015 | 24/07/2014 | A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment. MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Dekavil Product Code: F8IL10 INN or Proposed INN: dekavil Other descriptive name: F8IL10 | Philogen S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy;Switzerland | ||
| 1123 | EUCTR2013-004569-16-HU (EUCTR) | 03/02/2015 | 18/11/2014 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany | ||
| 1124 | EUCTR2013-003530-33-GB (EUCTR) | 02/02/2015 | 22/05/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand | ||
| 1125 | JPRN-JapicCTI-152979 | 01/2/2015 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Intervention name : Namilumab Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. Control intervention name : Placebo Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 20 | BOTH | 108 | Phase 2 | NULL | |||
| 1126 | NCT02633332 (ClinicalTrials.gov) | February 2015 | 30/11/2015 | Use of Well Known Drugs for New Destination - RA Improvement (RANT) | Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used Treatments | Rheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid Nodules | Drug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanercept | Università Popolare Homo & Natura | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 1 | Italy |
| 1127 | NCT02503046 (ClinicalTrials.gov) | February 2015 | 15/7/2015 | Estimation of Pentraxin3 and PGingivalis Levels in Patients With Knee Joint and Gum Diseases | Estimation of Pentraxin 3 and Porphyromonas Gingivalis Levels in Patients With Rheumatoid Arthritis and Periodontitis- An Observational Study | Rheumatoid Arthritis;Chronic Periodontitis | Other: Estimation of Pentraxin3;Genetic: Estimation of P.Gingivalis levels | Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre | NULL | Completed | 30 Years | 65 Years | Both | 90 | N/A | India |
| 1128 | NCT02390700 (ClinicalTrials.gov) | February 2015 | 11/3/2015 | Observational Study of Golimumab Intravenous Infusion | Golimumab Intravenous Infusion Registry (GO-IV) | Rheumatoid Arthritis | Biological: Golimumab Intravenous | Janssen Inc. | NULL | Terminated | 18 Years | N/A | Both | 78 | Canada | |
| 1129 | NCT02330445 (ClinicalTrials.gov) | February 2015 | 18/12/2014 | 6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection | Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers | Arthritis, Rheumatoid | Drug: PRTX-100 | Protalex, Inc. | NULL | Completed | 18 Years | N/A | All | 13 | Phase 1/Phase 2 | United States |
| 1130 | NCT02137226 (ClinicalTrials.gov) | January 26, 2015 | 12/5/2014 | BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis | Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial | Arthritis, Rheumatoid | Drug: BI 695501;Drug: US-licensed Humira® | Boehringer Ingelheim | NULL | Completed | 18 Years | 80 Years | All | 645 | Phase 3 | United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine;Argentina;Colombia;Mexico;Philippines;South Africa |
| 1131 | EUCTR2013-004019-37-BG (EUCTR) | 26/01/2015 | 02/09/2014 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 1132 | EUCTR2014-002541-22-CZ (EUCTR) | 26/01/2015 | 09/12/2014 | Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis | A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | Romania;Peru;South Africa;Germany;Korea, Republic of;Czech Republic;Hungary;Puerto Rico;Poland;United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom | ||
| 1133 | EUCTR2014-000109-11-DE (EUCTR) | 22/01/2015 | 08/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 730 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1134 | EUCTR2014-003255-54-CZ (EUCTR) | 21/01/2015 | 24/10/2014 | A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis | A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RGB-03 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Gedeon Richter Plc | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 1;Phase 3 | Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany | ||
| 1135 | EUCTR2014-000109-11-BG (EUCTR) | 21/01/2015 | 10/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 730 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1136 | NCT03719469 (ClinicalTrials.gov) | January 20, 2015 | 6/9/2018 | Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis | Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea | Rh Disease | Dietary Supplement: Green tea group | King Saud University | NULL | Completed | 18 Years | 85 Years | All | 150 | NULL | |
| 1137 | EUCTR2013-004019-37-DE (EUCTR) | 19/01/2015 | 24/07/2014 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 1138 | EUCTR2012-002535-28-IT (EUCTR) | 16/01/2015 | 04/11/2014 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Spain;Belgium;Netherlands;United Kingdom;Italy | ||
| 1139 | EUCTR2013-003530-33-BE (EUCTR) | 15/01/2015 | 19/09/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand | ||
| 1140 | ChiCTR-IPR-15005787 | 2015-01-15 | 2015-01-06 | The effect of food on the pharmacokinetics of Ginsenoside C-K | To study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers | rheumatoid arthritis | Two groups:Ginsenoside compound K is administrated after taking food versus fasting; | Institute of Clinical Pharmacology, Central South University | NULL | Pending | 18 | 45 | Both | Two groups:24; | I (Phase 1 study) | China |
| 1141 | EUCTR2013-004569-16-SK (EUCTR) | 14/01/2015 | 21/11/2014 | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany | ||
| 1142 | EUCTR2014-000358-13-ES (EUCTR) | 13/01/2015 | 22/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1143 | EUCTR2011-002067-20-FR (EUCTR) | 13/01/2015 | 23/08/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1144 | EUCTR2013-003530-33-BG (EUCTR) | 09/01/2015 | 06/11/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand | ||
| 1145 | EUCTR2010-021184-32-HU (EUCTR) | 09/01/2015 | 27/10/2014 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 1;Phase 2 | United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 1146 | EUCTR2013-005543-90-BG (EUCTR) | 06/01/2015 | 22/10/2014 | This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany | ||
| 1147 | EUCTR2014-000352-29-EE (EUCTR) | 05/01/2015 | 07/08/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia | ||
| 1148 | NCT02198651 (ClinicalTrials.gov) | January 5, 2015 | 22/7/2014 | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA) | Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases | Biological: Adalimumab;Other: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 149 | Phase 4 | United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 1149 | ChiCTR-INR-16009274 | 2015-01-01 | 2016-09-25 | The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms | The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms | Rheumatoid arthritis | RA No.1+fengshi mud:RA No.1+fengshi mud;MTX+LEF Group:MTX+LEF;RA No.1+fengshi mud+MTX+LEF Group:RA No.1+fengshi mud+MTX+LEF; | Zhejiang Chinese Medical University | NULL | Recruiting | 18 | 65 | Both | RA No.1+fengshi mud:150;MTX+LEF Group:150;RA No.1+fengshi mud+MTX+LEF Group:150; | China | |
| 1150 | NCT02744196 (ClinicalTrials.gov) | January 2015 | 4/4/2016 | Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis | Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Acellbia;Drug: Placebo;Drug: Methotrexate | Biocad | NULL | Completed | 18 Years | 80 Years | All | 159 | Phase 3 | NULL |
| 1151 | NCT02371096 (ClinicalTrials.gov) | January 2015 | 5/2/2015 | Comparative Pharmacokinetic Trial of RGB-03 and MabThera | Rheumatoid Arthritis | Drug: MabThera (rituximab);Drug: RGB-03 | Gedeon Richter Plc. | NULL | Not yet recruiting | 18 Years | 75 Years | Both | Phase 1 | NULL | ||
| 1152 | NCT02309359 (ClinicalTrials.gov) | January 2015 | 27/11/2014 | A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Biological: ALX-0061;Other: Placebo;Drug: Methotrexate | Ablynx | NULL | Completed | 18 Years | 74 Years | All | 345 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of |
| 1153 | NCT02837978 (ClinicalTrials.gov) | January 2015 | 13/7/2016 | The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Tacrolimus;Drug: MTX | Qiang Shu | NULL | Recruiting | 18 Years | 80 Years | All | 150 | Phase 4 | China |
| 1154 | NCT02927535 (ClinicalTrials.gov) | January 2015 | 16/9/2016 | Evaluation of TNFa Blockers Monotherapy in Early Rheumatoid Arthritis in France | Rheumatoid Arthritis | Drug: TNF blockers monotherapy | Centre Hospitalier Universitaire de Nimes | Pfizer;Pfizer | Completed | 18 Years | 70 Years | Both | 813 | N/A | NULL | |
| 1155 | NCT04192617 (ClinicalTrials.gov) | December 31, 2014 | 5/12/2019 | A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate | A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase II Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severe Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: SM03;Drug: Placebo;Drug: Methotrexate | SinoMab Pty Ltd | NULL | Completed | 18 Years | 75 Years | All | 156 | Phase 2 | China |
| 1156 | JPRN-UMIN000012650 | 2014/12/31 | 21/12/2013 | In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique. | In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique. - Kinematic analysis of total knee arthroplasty. | osteoarthritis or rheumatoid arthritis of the knee joint | Fluoroscopy was performed to continuously capture the knee from the lateral direction in a weight-bearing position and knee bending position. | Dept. of orthopedic surgery, Osaka Medical College | NULL | Recruiting | 20years-old | 90years-old | Male and Female | 60 | Not selected | Japan |
| 1157 | EUCTR2014-000443-33-DE (EUCTR) | 18/12/2014 | 07/07/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302 | Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 620 | Phase 3 | United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan | ||
| 1158 | EUCTR2014-000109-11-CZ (EUCTR) | 18/12/2014 | 09/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1159 | NCT02379091 (ClinicalTrials.gov) | December 17, 2014 | 28/11/2014 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Namilumab;Drug: Placebo;Drug: Methotrexate;Drug: Folic/folinic acid | Takeda | NULL | Completed | 18 Years | N/A | All | 108 | Phase 2 | Bulgaria;Czechia;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom;Argentina;Brazil;Colombia;Czech Republic;Germany;Mexico |
| 1160 | EUCTR2014-003529-16-GB (EUCTR) | 16/12/2014 | 22/06/2015 | Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology | Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel | Joint Research & Development Office (QMUL) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 219 | Phase 3 | United Kingdom | ||
| 1161 | EUCTR2014-002945-23-EE (EUCTR) | 16/12/2014 | 27/11/2014 | A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI. | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis. | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 9 | Phase 2 | Czech Republic;Estonia;Spain;Russian Federation;United Kingdom | ||
| 1162 | JPRN-UMIN000020663 | 2014/12/16 | 21/01/2016 | A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. | A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. - A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. | Rheumatoid arthritis | Period :12 months Patients take Tofacitinib 5mg twice a day. | Kyusyu University Hospital Medicine and biosystemic science | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 1163 | JPRN-UMIN000015794 | 2014/12/15 | 10/12/2014 | Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) | Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) - RISOTTO(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis) | osteoporosis, rheumatoid arthritis | monthly risedronate sodium 75mg for 6 months monthly placebo for 6 months | Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 165 | Phase 4 | Japan |
| 1164 | EUCTR2014-001114-26-GR (EUCTR) | 12/12/2014 | 02/12/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1165 | EUCTR2014-000352-29-DE (EUCTR) | 11/12/2014 | 13/10/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1166 | EUCTR2013-003530-33-NL (EUCTR) | 11/12/2014 | 22/05/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 2 | United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of | ||
| 1167 | NCT02328027 (ClinicalTrials.gov) | December 11, 2014 | 18/12/2014 | 99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS) | A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: 99mTc-rhAnnexin V-128 | Advanced Accelerator Applications | NULL | Terminated | 18 Years | N/A | All | 16 | Phase 1/Phase 2 | Switzerland |
| 1168 | EUCTR2014-001114-26-IE (EUCTR) | 11/12/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1169 | EUCTR2014-000109-11-ES (EUCTR) | 09/12/2014 | 04/11/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1170 | EUCTR2014-000352-29-HU (EUCTR) | 05/12/2014 | 09/10/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1171 | EUCTR2014-000993-20-SE (EUCTR) | 04/12/2014 | 02/09/2014 | Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases | Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis | Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 | Center for Research and Development Uppsala University/County Council of Gävleborg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Sweden | ||
| 1172 | EUCTR2014-000358-13-CZ (EUCTR) | 04/12/2014 | 04/08/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1173 | EUCTR2014-000358-13-PL (EUCTR) | 03/12/2014 | 24/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1174 | ChiCTR1800014846 | 2014-12-01 | 2018-02-09 | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trial | osteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitis | Experiment group:preoperative intravenous parecoxib sodium and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Control Group:preoperative intravenous pure 0.9% saline and postoperative intravenous parecoxib sodium and patient-controlled analgesia; | Peking Union Medical College Hospital | NULL | Completed | Both | Experiment group:50;Control Group:50; | China | |||
| 1175 | NCT02260791 (ClinicalTrials.gov) | December 2014 | 29/7/2014 | A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 728 | Phase 3 | United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia |
| 1176 | NCT02876874 (ClinicalTrials.gov) | December 2014 | 3/2/2015 | Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage | the Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels | Rheumatoid Arthritis;Lymph Node Mass;Lymphatic Vessel; Dilatation | Drug: indocyanine green(ICG) | Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 Years | 65 Years | Both | 21 | N/A | China |
| 1177 | EUCTR2013-001417-32-BG (EUCTR) | 27/11/2014 | 16/09/2014 | A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of | ||
| 1178 | EUCTR2014-001114-26-GB (EUCTR) | 25/11/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1179 | EUCTR2013-003984-72-CZ (EUCTR) | 24/11/2014 | 14/04/2014 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;South Africa;Latvia | ||
| 1180 | EUCTR2013-003530-33-CZ (EUCTR) | 24/11/2014 | 09/05/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand | ||
| 1181 | EUCTR2013-002622-23-GR (EUCTR) | 20/11/2014 | 23/10/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1182 | EUCTR2014-002374-36-SE (EUCTR) | 19/11/2014 | 27/08/2014 | A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity. | A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Methotrexate Trade Name: Metoject Trade Name: Azathioprine Trade Name: Leflunomide | The Karolinska Institutet, ClinTRID | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Sweden | ||
| 1183 | EUCTR2013-005543-90-DE (EUCTR) | 19/11/2014 | 16/06/2014 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: RITUXIMAB Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany | ||
| 1184 | NCT02281552 (ClinicalTrials.gov) | November 18, 2014 | 30/10/2014 | A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate | Rheumatoid Arthritis | Drug: Tofacitinib | Pfizer | NULL | Completed | 20 Years | N/A | All | 209 | Phase 3 | Japan |
| 1185 | EUCTR2014-001114-26-ES (EUCTR) | 17/11/2014 | 01/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1186 | EUCTR2014-001114-26-FR (EUCTR) | 13/11/2014 | 18/06/2015 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1187 | EUCTR2014-000358-13-EE (EUCTR) | 13/11/2014 | 07/08/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1188 | EUCTR2014-000358-13-GB (EUCTR) | 12/11/2014 | 12/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1189 | EUCTR2014-001114-26-DE (EUCTR) | 10/11/2014 | 08/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1190 | EUCTR2014-000358-13-RO (EUCTR) | 10/11/2014 | 10/03/2015 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1191 | EUCTR2014-000352-29-LT (EUCTR) | 06/11/2014 | 08/10/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1192 | EUCTR2013-002805-76-ES (EUCTR) | 06/11/2014 | 19/08/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. | Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | United States;Spain;Russian Federation;Colombia;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Korea, Republic of | ||
| 1193 | EUCTR2014-000358-13-BG (EUCTR) | 06/11/2014 | 28/10/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1194 | EUCTR2014-001114-26-AT (EUCTR) | 05/11/2014 | 10/10/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1195 | EUCTR2013-004019-37-HU (EUCTR) | 04/11/2014 | 31/07/2014 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand;Poland;Czech Republic;Hungary;Canada | ||
| 1196 | JPRN-UMIN000015616 | 2014/11/04 | 10/11/2014 | Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction | Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction - Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction | rheumatoid arthritis | Adalimumab plus Methotrexate Tocilizumab plus Methotrexate | Biologic Mate Study Group | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 300 | Not selected | Japan |
| 1197 | EUCTR2014-001114-26-HU (EUCTR) | 04/11/2014 | 10/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 1198 | NCT02551575 (ClinicalTrials.gov) | November 2014 | 26/8/2015 | Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis | Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial | Rheumatoid Arthritis | Drug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative Medicine | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 468 | Phase 2/Phase 3 | China |
| 1199 | NCT02287610 (ClinicalTrials.gov) | November 2014 | 6/11/2014 | A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis | A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting | Rheumatoid Arthritis | Drug: RAYOS (delayed-release prednisone) | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | N/A | All | 75 | N/A | NULL |
| 1200 | NCT02296775 (ClinicalTrials.gov) | November 2014 | 18/11/2014 | Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: DRL_RI;Biological: Rituxan;Biological: MabThera | Dr. Reddy's Laboratories Limited | NULL | Completed | 18 Years | 65 Years | All | 276 | Phase 1/Phase 2 | India;Ukraine | |
| 1201 | EUCTR2014-000443-33-PL (EUCTR) | 29/10/2014 | 21/07/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302 | Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus BioSciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 620 | Phase 3 | United States;Belarus;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;South Africa;Germany;Japan | ||
| 1202 | EUCTR2014-000352-29-GB (EUCTR) | 29/10/2014 | 09/10/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1203 | EUCTR2014-000352-29-CZ (EUCTR) | 27/10/2014 | 05/08/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PR-06410293 INN or Proposed INN: ADALIMUMAB | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1204 | EUCTR2014-000443-33-ES (EUCTR) | 24/10/2014 | 04/07/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302 | Rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Belarus;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan | ||
| 1205 | EUCTR2014-000443-33-IT (EUCTR) | 24/10/2014 | 24/06/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302 | Rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Belarus;Spain;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan | ||
| 1206 | EUCTR2014-000352-29-ES (EUCTR) | 23/10/2014 | 29/10/2014 | A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02). | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 3 | Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 1207 | EUCTR2013-004019-37-RO (EUCTR) | 22/10/2014 | 05/03/2015 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 1208 | EUCTR2013-004148-49-PL (EUCTR) | 21/10/2014 | 27/08/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan | ||
| 1209 | EUCTR2014-000443-33-GB (EUCTR) | 20/10/2014 | 26/06/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02)(RApsody) - ETA 302 | Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus BioSciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 620 | Phase 3 | United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan | ||
| 1210 | EUCTR2014-001114-26-IT (EUCTR) | 20/10/2014 | 16/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 1211 | EUCTR2013-004148-49-BG (EUCTR) | 20/10/2014 | 01/09/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia | ||
| 1212 | EUCTR2013-004019-37-CZ (EUCTR) | 15/10/2014 | 05/09/2014 | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 1213 | EUCTR2013-002805-76-GB (EUCTR) | 09/10/2014 | 30/12/2013 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Germany;Japan;United Kingdom | ||
| 1214 | EUCTR2014-001299-79-DK (EUCTR) | 06/10/2014 | 07/07/2014 | Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment | Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA | Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Prevenar 13 INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE Trade Name: Pneumovax INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT) | Department of Infectious Diseases, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Denmark | |||
| 1215 | EUCTR2013-002805-76-DE (EUCTR) | 06/10/2014 | 27/01/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study. | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | Czech Republic;Mexico;Argentina;Poland;Brazil;Spain;Russian Federation;Bulgaria;Colombia;Germany;United Kingdom;Korea, Republic of | ||
| 1216 | EUCTR2014-000706-34-GB (EUCTR) | 06/10/2014 | 18/07/2014 | A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT | RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib citrate Product Code: CP-690,550 – 10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;Hungary;Germany;United Kingdom | ||
| 1217 | EUCTR2014-000358-13-LT (EUCTR) | 03/10/2014 | 11/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 1218 | EUCTR2014-000859-91-FR (EUCTR) | 03/10/2014 | 18/06/2015 | Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. | Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX | Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab. MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB | CHRU de TOURS | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 1219 | NCT02270632 (ClinicalTrials.gov) | October 1, 2014 | 16/10/2014 | A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate. | Rheumatoid Arthritis | Drug: F8IL10;Drug: MTX;Drug: Placebo | Philogen S.p.A. | NULL | Active, not recruiting | 18 Years | 74 Years | All | 27 | Phase 2 | Germany;Italy;Switzerland |
| 1220 | JPRN-UMIN000015217 | 2014/10/01 | 01/10/2014 | Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis | Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis - Orencia Atherosclerosis And Rheumatoid Arthritis Study(ORACLE Arthritis Study) | RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy. | Abatacept | Yokohama City University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not applicable | Japan |
| 1221 | JPRN-UMIN000015462 | 2014/10/01 | 17/10/2014 | Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) | Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) - Clinical study on rheumatoid arthritis treated with tofacitinib | Rheumatoid arthritis | Continue current treatment Tofacitinib discontinuation MTX discontinuation | School of Medicine, University of Occupational and Environmental Health, Japan | NULL | Recruiting | 18years-old | Not applicable | Male and Female | 400 | Not selected | Japan |
| 1222 | NCT02500498 (ClinicalTrials.gov) | October 2014 | 15/7/2015 | Safety Profile of Nulojix in Home Infusion Settings | Safety Profile of Nulojix in Home Infusion Settings | Rheumatoid Arthritis | Drug: Nulojix | Bristol-Myers Squibb | BiologicTx, LLC | Completed | 18 Years | N/A | Both | 37 | N/A | NULL |
| 1223 | NCT02257047 (ClinicalTrials.gov) | October 2014 | 2/10/2014 | Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Dietary Supplement: Tea;Dietary Supplement: RYR | Chengdu PLA General Hospital | NULL | Enrolling by invitation | 18 Years | 75 Years | All | 120 | N/A | China | |
| 1224 | NCT02265705 (ClinicalTrials.gov) | October 2014 | 13/10/2014 | A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA) | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 290 | Phase 3 | Argentina;Brazil;China |
| 1225 | NCT02221258 (ClinicalTrials.gov) | October 2014 | 18/8/2014 | Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA) | Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: FURESTEM-RA Inj. | Kang Stem Biotech Co., Ltd. | NULL | Completed | 19 Years | 80 Years | Both | 9 | Phase 1 | Korea, Republic of |
| 1226 | EUCTR2014-000358-13-LV (EUCTR) | 26/09/2014 | 11/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1227 | EUCTR2011-005689-39-SK (EUCTR) | 24/09/2014 | 07/07/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 1228 | EUCTR2013-004555-21-GR (EUCTR) | 22/09/2014 | 21/03/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 1229 | EUCTR2012-002945-40-DE (EUCTR) | 22/09/2014 | 01/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 1230 | EUCTR2013-002358-57-BE (EUCTR) | 18/09/2014 | 15/07/2014 | A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Spain;Belgium;Australia;Netherlands;United Kingdom | ||
| 1231 | EUCTR2013-005418-37-IT (EUCTR) | 15/09/2014 | 06/03/2014 | A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Dekavil Product Code: F8IL10 INN or Proposed INN: dekavil Other descriptive name: F8IL10 | Philogen S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy | ||
| 1232 | EUCTR2013-002805-76-CZ (EUCTR) | 11/09/2014 | 17/07/2014 | A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis. | A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS. | Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom | ||
| 1233 | EUCTR2011-004720-35-FI (EUCTR) | 10/09/2014 | 09/09/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Sweden | |||
| 1234 | EUCTR2014-000443-33-HU (EUCTR) | 09/09/2014 | 06/06/2014 | Coherus RA Study | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302 | Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Coherus Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 620 | Phase 3 | United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan | ||
| 1235 | EUCTR2013-003177-99-NL (EUCTR) | 09/09/2014 | 25/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1236 | EUCTR2013-005543-90-PL (EUCTR) | 09/09/2014 | 11/07/2014 | This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany | ||
| 1237 | EUCTR2012-003654-86-BG (EUCTR) | 04/09/2014 | 21/05/2014 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1238 | EUCTR2011-005689-39-NL (EUCTR) | 01/09/2014 | 23/06/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Spain;Poland;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 1239 | JPRN-UMIN000014624 | 2014/09/01 | 23/07/2014 | Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. | Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. - EPOCA | Osteoarthritis, Rheumatoid arthritis | Administration of celecoxib from 2 hours after TKA surgery Administration of celecoxib from 2 days after TKA surgery | Mito medical center, Mito Kyodo General Hospital, University of Tsukuba | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 120 | Phase 4 | Japan |
| 1240 | NCT02097264 (ClinicalTrials.gov) | September 2014 | 24/3/2014 | A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: Adalimumab;Drug: placebo | Novo Nordisk A/S | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2 | Ireland;Portugal;Spain;United Kingdom |
| 1241 | EUCTR2013-005543-90-HU (EUCTR) | 26/08/2014 | 13/05/2014 | This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany | ||
| 1242 | NCT02222493 (ClinicalTrials.gov) | August 26, 2014 | 19/8/2014 | A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02). | A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate | Rheumatoid Arthritis | Biological: PF-06438179;Biological: Infliximab | Pfizer | NULL | Completed | 18 Years | N/A | All | 650 | Phase 3 | United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France |
| 1243 | EUCTR2012-002945-40-BG (EUCTR) | 21/08/2014 | 05/08/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 1244 | EUCTR2012-003655-11-CZ (EUCTR) | 21/08/2014 | 21/08/2014 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: filgotinib Product Code: GLPG0634 INN or Proposed INN: INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | Spain;Ukraine;Guatemala;Austria;Russian Federation;Chile;Israel;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of;United States | ||
| 1245 | EUCTR2013-004148-49-HU (EUCTR) | 13/08/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 1246 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Norway | ||
| 1247 | NCT02202837 (ClinicalTrials.gov) | August 12, 2014 | 15/7/2014 | Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice | Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered)) | Rheumatoid Arthritis | Drug: etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 157 | Belgium | |
| 1248 | NCT02308163 (ClinicalTrials.gov) | August 8, 2014 | 2/12/2014 | A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs | Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs | Rheumatoid Arthritis | Drug: Peficitinib;Drug: Placebo;Biological: Etanercept | Astellas Pharma Inc | NULL | Completed | 20 Years | N/A | All | 509 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 1249 | EUCTR2013-002622-23-DE (EUCTR) | 06/08/2014 | 27/03/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1250 | EUCTR2013-004604-19-DE (EUCTR) | 06/08/2014 | 03/06/2014 | Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patients | Delayed Gadolinium-enhanced Magnetic resonance Imaging (MRI) of Cartilage - A pilot study to measure the effect of Adalimumab plus Methotrexat (MTX) versus Placebo plus MTX on cartilage in early rheumatoid arthritis (RA) patients | patients with early progressive rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Trade Name: Humira 40mg Injektionslösung Product Name: Humira | Heinrich-Heine-Universität Düsseldorf | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany | ||
| 1251 | ChiCTR-RNC-14004887 | 2014-08-01 | 2014-06-30 | The pharmacogenomics study on Methotrexate in treating rheumatoid arthritis | The pharmacogenomics study on Methotrexate in treating rheumatoid arthritis | rheumatoid arthritis | Case series:Methotrexate; | The people's hospital, Yichun City | NULL | Recruiting | 18 | 65 | Case series:400; | China | ||
| 1252 | JPRN-UMIN000014737 | 2014/08/01 | 01/08/2014 | The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. | The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. - Two Birds trial | rheumatoid arthritis | Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D. BP group: Patients take BP continuously. All patients are to take vitamin D. | Yokohama City University Medical Center | NULL | Complete: follow-up complete | 50years-old | 90years-old | Male and Female | 286 | Not selected | Japan |
| 1253 | NCT04752748 (ClinicalTrials.gov) | August 2014 | 10/2/2021 | Power Doppler in Hand Joints of Early RA Patients | Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment | Early Rheumatoid Arthritis | Drug: Drug protocol | Federal University of São Paulo | NULL | Completed | 18 Years | 65 Years | Female | 48 | NULL | |
| 1254 | NCT02149121 (ClinicalTrials.gov) | August 2014 | 23/5/2014 | PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P10;Drug: Rituxan;Drug: MabThera | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 384 | Phase 3 | Austria;Korea, Republic of |
| 1255 | NCT02187055 (ClinicalTrials.gov) | August 2014 | 8/7/2014 | An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate | A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis | Rhematoid Arthritis | Drug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexate | Pfizer | NULL | Completed | 18 Years | N/A | All | 1152 | Phase 4 | United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czechia;Estonia;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia;Czech Republic;France |
| 1256 | NCT02234960 (ClinicalTrials.gov) | August 2014 | 5/9/2014 | Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA) | TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 102 | N/A | Poland |
| 1257 | NCT02264301 (ClinicalTrials.gov) | August 2014 | 3/10/2014 | Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis | The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 ml | Chengdu PLA General Hospital | NULL | Enrolling by invitation | 18 Years | 75 Years | All | 150 | N/A | China |
| 1258 | NCT02176876 (ClinicalTrials.gov) | August 2014 | 25/6/2014 | Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis | A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | NULL | Completed | 18 Years | 70 Years | Both | 18 | Phase 1 | Czech Republic;Hungary |
| 1259 | NCT02219191 (ClinicalTrials.gov) | August 2014 | 16/7/2014 | Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases | The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases | Rheumatoid Arthritis | Drug: puerarin tablet 50 mg;Drug: Atorvastatin tablet 20 mg | Chengdu PLA General Hospital | NULL | Active, not recruiting | 18 Years | 75 Years | All | 150 | N/A | China |
| 1260 | NCT02211469 (ClinicalTrials.gov) | August 2014 | 6/8/2014 | A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects | A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects | Rheumatoid Arthritis | Drug: BMS-986104;Drug: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 49 Years | Male | 41 | Phase 1 | United States |
| 1261 | EUCTR2013-002358-57-NL (EUCTR) | 30/07/2014 | 24/02/2014 | A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom | ||
| 1262 | EUCTR2013-002622-23-ES (EUCTR) | 29/07/2014 | 25/04/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 INN or Proposed INN: Not applicable | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1263 | EUCTR2013-004148-49-DE (EUCTR) | 28/07/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany | ||
| 1264 | EUCTR2013-003530-33-LV (EUCTR) | 28/07/2014 | 17/06/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 Product Name: ABT-494 30mg INN or Proposed INN: ABT-494 Product Name: ABT-494 15mg INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Netherlands;Latvia;New Zealand | ||
| 1265 | NCT02305849 (ClinicalTrials.gov) | July 25, 2014 | 1/12/2014 | A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment | Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX | Rheumatoid Arthritis | Drug: Peficitinib;Drug: Placebo;Drug: Methotrexate | Astellas Pharma Inc | NULL | Completed | 20 Years | N/A | All | 519 | Phase 3 | Japan |
| 1266 | EUCTR2013-003177-99-GB (EUCTR) | 17/07/2014 | 11/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1267 | EUCTR2013-004148-49-LT (EUCTR) | 14/07/2014 | 23/05/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina | ||
| 1268 | EUCTR2013-003177-99-CZ (EUCTR) | 10/07/2014 | 05/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | Mexico;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1269 | EUCTR2012-002945-40-ES (EUCTR) | 07/07/2014 | 29/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 1270 | JPRN-UMIN000016928 | 2014/07/03 | 26/03/2015 | Targeted Ultrasound in Rheumatoid Arthritis | Targeted Ultrasound in Rheumatoid Arthritis - TURA | Rheumatoid arthritis | If DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week. If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week. | Leeds University | NULL | Recruiting | 18years-old | Not applicable | Male and Female | 400 | Not selected | Japan,Europe |
| 1271 | EUCTR2013-004148-49-GB (EUCTR) | 03/07/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 1272 | JPRN-UMIN000015175 | 2014/07/01 | 17/09/2014 | Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. | Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. - STAR study | Rheumatoid Arthritis | Subcutaneous Tocilizumab 162mg every other week. Subcutaneous Abatacept 125mg every week. | St.Marianna University School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 120 | Not selected | Japan |
| 1273 | NCT02053727 (ClinicalTrials.gov) | July 2014 | 6/11/2013 | Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background | Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial. | Rheumatoid Arthritis;Chronic Hepatitis B | Drug: Abatacept;Drug: Placebo | University of California, Los Angeles | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United States |
| 1274 | NCT02011334 (ClinicalTrials.gov) | July 2014 | 4/12/2013 | A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs. | A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 285 | Phase 3 | Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay |
| 1275 | NCT02141997 (ClinicalTrials.gov) | July 2014 | 16/5/2014 | A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: adalimumab;Biological: ABT-122 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 222 | Phase 2 | Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey;United States |
| 1276 | EUCTR2013-001417-32-ES (EUCTR) | 30/06/2014 | 22/05/2014 | A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden | ||
| 1277 | EUCTR2013-003984-72-ES (EUCTR) | 30/06/2014 | 09/05/2014 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia | ||
| 1278 | EUCTR2013-004654-13-RO (EUCTR) | 27/06/2014 | 30/05/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1279 | EUCTR2013-003530-33-ES (EUCTR) | 26/06/2014 | 17/03/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494 | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 2 | United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of | ||
| 1280 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 1281 | JPRN-UMIN000014311 | 2014/06/24 | 24/06/2014 | Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis | Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis - Examination of the clinical remission and functional remission in Infliximab using an increase-in-quantity protocol | rheumatoid arthritis | The quantity of Infliximab is increased. | Institute of Health Biosciences,The University of Tokushima Graduate School | NULL | Pending | 20years-old | 75years-old | Male and Female | 10 | Not selected | Japan |
| 1282 | EUCTR2013-002622-23-NL (EUCTR) | 24/06/2014 | 17/02/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 INN or Proposed INN: Rituximab | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1283 | ChiCTR-TRC-14004824 | 2014-06-23 | 2014-06-19 | Clinical studies on Ginsenoside C-K | Study on tolerability and pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers after a single dose | rheumatoid arthritis | 7 groups:Seven different doses with ginsenoside compound K; | Institute of Clinical Pharmacology, Central South University | NULL | Completed | 18 | 45 | Both | 7 groups:77; | I (Phase 1 study) | China |
| 1284 | EUCTR2013-003984-72-SK (EUCTR) | 23/06/2014 | 15/04/2014 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia | ||
| 1285 | EUCTR2010-019262-86-BE (EUCTR) | 20/06/2014 | 04/03/2014 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1286 | EUCTR2013-004148-49-CZ (EUCTR) | 20/06/2014 | 05/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 1287 | EUCTR2013-001417-32-LT (EUCTR) | 19/06/2014 | 07/04/2014 | A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of | ||
| 1288 | EUCTR2013-003530-33-HU (EUCTR) | 18/06/2014 | 26/03/2014 | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 494 | Phase 2 | United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand | ||
| 1289 | EUCTR2012-003686-17-SI (EUCTR) | 17/06/2014 | 03/04/2014 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1290 | ChiCTR-BOC-16008925 | 2014-06-10 | 2016-07-27 | Circulating Tfh subpopulation in very early rheumatoid arthritis | Circulating Bcl-6+ICOS+ Tfh subpopulation correlates with disease activity in very early rheumatoid arthritis | Rheumatoid Arthritis | RA patients:methotrexate;Healthy control (HC) individuals:Nil; | The First Hospital, Jilin University, Changchun | NULL | Completed | Both | RA patients:22;Healthy control (HC) individuals:15; | China | |||
| 1291 | JPRN-JapicCTI-142621 | 09/6/2014 | CHS-0214 Phase III trial | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate | Rheumatoid Arthritis | Intervention name : CHS-0214 Dosage And administration of the intervention : subcutaneous injection Control intervention name : Enbrel INN of the control intervention : Etanercept Dosage And administration of the control intervention : subcutaneous injection | DAIICHISANKYO Co.,Ltd. | Coherus Biosciences, Inc. | 20 | BOTH | 620 | Phase 3 | NULL | |||
| 1292 | EUCTR2012-002535-28-PT (EUCTR) | 06/06/2014 | 25/02/2014 | Not applicable | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 1293 | EUCTR2013-002622-23-HU (EUCTR) | 03/06/2014 | 02/04/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1294 | EUCTR2013-002790-22-HU (EUCTR) | 02/06/2014 | 03/04/2014 | To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA) | An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile | |||
| 1295 | EUCTR2013-001417-32-DE (EUCTR) | 02/06/2014 | 18/02/2014 | A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden | ||
| 1296 | ChiCTR1900026116 | 2014-06-01 | 2019-09-22 | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | rheumatoid arthritis | Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine; | Central Hospital of Jinhua | NULL | Completed | 21 | 73 | Both | Experimental group:40;control group:40; | Phase 4 | China |
| 1297 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 1298 | NCT02147587 (ClinicalTrials.gov) | June 2014 | 22/5/2014 | A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 50 Years | N/A | All | 112 | Phase 2 | United States;United Kingdom |
| 1299 | NCT02202395 (ClinicalTrials.gov) | June 2014 | 23/7/2014 | Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: LTS 0.25mg;Drug: LTS 0.5mg;Drug: LTS 1.0mg;Drug: Placebo | Shanghai Pharmaceuticals Holding Co., Ltd | NULL | Completed | 35 Years | 65 Years | Female | 120 | Phase 1/Phase 2 | China |
| 1300 | EUCTR2012-001176-10-PL (EUCTR) | 31/05/2014 | 28/04/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1301 | EUCTR2013-002790-22-EE (EUCTR) | 30/05/2014 | 07/05/2014 | To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA) | An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile | |||
| 1302 | EUCTR2013-003984-72-LV (EUCTR) | 30/05/2014 | 28/03/2014 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia | ||
| 1303 | NCT02046616 (ClinicalTrials.gov) | May 28, 2014 | 24/1/2014 | A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound. | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 133 | Phase 3 | Denmark;Finland;Norway;Sweden |
| 1304 | EUCTR2011-004720-35-DK (EUCTR) | 28/05/2014 | 24/02/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Netherlands;Norway;Iceland;Sweden | ||
| 1305 | EUCTR2012-002945-40-HU (EUCTR) | 27/05/2014 | 04/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 1306 | EUCTR2013-001417-32-HU (EUCTR) | 27/05/2014 | 17/03/2014 | A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of | ||
| 1307 | EUCTR2013-003493-27-GR (EUCTR) | 27/05/2014 | 16/04/2014 | Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work. | A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201 | Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: QAL964 Other descriptive name: QAL964 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | Hungary;Greece;Ukraine;Romania;Russian Federation | |||
| 1308 | EUCTR2012-003654-86-LV (EUCTR) | 26/05/2014 | 24/04/2014 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone. | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand | ||
| 1309 | NCT02196558 (ClinicalTrials.gov) | May 26, 2014 | 16/7/2014 | A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis | A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: E6011 | Eisai Co., Ltd. | NULL | Completed | 20 Years | 64 Years | All | 53 | Phase 1/Phase 2 | Japan |
| 1310 | EUCTR2012-004339-21-PL (EUCTR) | 25/05/2014 | 23/04/2014 | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy - SARIL-RA-EASY | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Poland;Russian Federation;Chile;South Africa | ||
| 1311 | EUCTR2013-004654-13-DE (EUCTR) | 22/05/2014 | 03/02/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1312 | EUCTR2013-002790-22-CZ (EUCTR) | 21/05/2014 | 08/04/2014 | To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA) | An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile | ||
| 1313 | EUCTR2013-003984-72-HU (EUCTR) | 20/05/2014 | 04/04/2014 | A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone. | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia | ||
| 1314 | EUCTR2012-002945-40-EE (EUCTR) | 09/05/2014 | 10/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 1315 | EUCTR2010-019262-86-SE (EUCTR) | 09/05/2014 | 24/03/2014 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1316 | EUCTR2013-002622-23-PT (EUCTR) | 09/05/2014 | 28/02/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1317 | EUCTR2012-001176-10-HR (EUCTR) | 08/05/2014 | 05/09/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1318 | EUCTR2013-003177-99-ES (EUCTR) | 07/05/2014 | 17/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1319 | ChiCTR-TRC-14004520 | 2014-05-01 | 2014-04-13 | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolism | rheumatoid arthritis | two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA; | General Hospital of Chengdu Military Region | NULL | Recruiting | 45 | 65 | Both | two:240;RA patients:40; | I (Phase 1 study) | China |
| 1320 | NCT02105129 (ClinicalTrials.gov) | May 2014 | 19/3/2014 | A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523 | A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523 | Rheumatoid Arthritis (RA) | Drug: HMPL-523;Drug: Placebo | Hutchison Medipharma Limited | NULL | Completed | 18 Years | 45 Years | Male | 118 | Phase 1 | Australia |
| 1321 | NCT02927509 (ClinicalTrials.gov) | May 2014 | 15/9/2016 | Evaluation of Tumour Necrosis Factor Alpha (TNFa) Blockers in Early Rheumatoid Arthritis in France | Rheumatoid Arthritis | Drug: TNF alpha blockers | Centre Hospitalier Universitaire de Nimes | Pfizer;Pfizer | Completed | 18 Years | 70 Years | Both | 813 | N/A | NULL | |
| 1322 | NCT02167139 (ClinicalTrials.gov) | May 2014 | 16/6/2014 | A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Humira (adalimumab);Drug: SB5 (proposed biosimilar to adalimumab) | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 544 | Phase 3 | Lithuania;Poland |
| 1323 | NCT02151474 (ClinicalTrials.gov) | May 2014 | 28/5/2014 | INCB047986 in Rheumatoid Arthritis | A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: INCB047986;Drug: Placebo | Incyte Corporation | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 2 | United States |
| 1324 | NCT02123264 (ClinicalTrials.gov) | May 2014 | 23/4/2014 | Zoledronic Acid in Rheumatoid Arthritis | Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity | Arthritis, Rheumatoid | Drug: Zoledronic acid | Carmen Gómez-Vaquero | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 3 | Spain |
| 1325 | EUCTR2013-003177-99-SK (EUCTR) | 28/04/2014 | 10/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1326 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 1327 | EUCTR2012-002535-28-BE (EUCTR) | 28/04/2014 | 28/03/2014 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 1328 | EUCTR2012-001176-10-NL (EUCTR) | 18/04/2014 | 28/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China | ||
| 1329 | EUCTR2013-004654-13-BG (EUCTR) | 14/04/2014 | 18/03/2014 | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1330 | EUCTR2013-004654-13-PL (EUCTR) | 13/04/2014 | 03/04/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1331 | EUCTR2013-003177-99-SE (EUCTR) | 11/04/2014 | 05/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 1332 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1333 | EUCTR2013-003493-27-HU (EUCTR) | 08/04/2014 | 30/01/2014 | Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work. | A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201 | Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: QAL964 Other descriptive name: QAL964 | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Hungary;Ukraine;Russian Federation | |||
| 1334 | EUCTR2013-004555-21-SK (EUCTR) | 07/04/2014 | 23/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 1335 | EUCTR2013-004555-21-AT (EUCTR) | 07/04/2014 | 02/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
| 1336 | NCT04582084 (ClinicalTrials.gov) | April 4, 2014 | 3/10/2020 | Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis | Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Etanercept | AryoGen Pharmed Co. | NULL | Completed | 18 Years | N/A | All | 583 | Iran, Islamic Republic of | |
| 1337 | EUCTR2013-002358-57-CZ (EUCTR) | 04/04/2014 | 11/12/2013 | A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom | ||
| 1338 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1339 | EUCTR2013-004555-21-HU (EUCTR) | 02/04/2014 | 23/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany | ||
| 1340 | EUCTR2013-002622-23-BE (EUCTR) | 02/04/2014 | 26/03/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1341 | JPRN-UMIN000013440 | 2014/04/01 | 18/03/2014 | To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. | To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. - Subcutaneous and abatacept versus intravenous abatacept. | Rheumatoid arthritis | SC abatacept IV abatacept Extension of SC abatacept | Osaka Medical College | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 50 | Not selected | Japan |
| 1342 | NCT02109289 (ClinicalTrials.gov) | April 2014 | 3/4/2014 | Etanercept in Rheumatoid Arthritis and Vascular Inflammation | Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis;Vascular Inflammation | Drug: etanercept | Innovaderm Research Inc. | NULL | Terminated | 18 Years | 80 Years | All | 5 | Phase 4 | Canada |
| 1343 | NCT02114931 (ClinicalTrials.gov) | April 2014 | 11/4/2014 | Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis | An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: ABP 501 | Amgen | NULL | Completed | 18 Years | 81 Years | All | 467 | Phase 3 | United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Poland;Romania;Russian Federation;Spain;United Kingdom |
| 1344 | NCT02101073 (ClinicalTrials.gov) | March 31, 2014 | 27/3/2014 | ALX-0061 Phase I Bioavailability Study in Healthy Volunteers | A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers. | Rheumatoid Arthritis | Biological: ALX-0061 | Ablynx | NULL | Completed | 18 Years | 55 Years | All | 70 | Phase 1 | Netherlands |
| 1345 | EUCTR2013-004555-21-DE (EUCTR) | 31/03/2014 | 17/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 1346 | EUCTR2013-002622-23-BG (EUCTR) | 27/03/2014 | 21/03/2014 | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: Bi 695500 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1347 | EUCTR2012-003655-11-BG (EUCTR) | 27/03/2014 | 19/02/2014 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 1348 | NCT02066389 (ClinicalTrials.gov) | March 26, 2014 | 17/2/2014 | A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone | Rheumatoid Arthritis | Drug: Placebo;Drug: Upadacitinib | AbbVie | NULL | Completed | 18 Years | 100 Years | All | 300 | Phase 2 | United States;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;Czech Republic;Romania;Serbia |
| 1349 | EUCTR2013-004654-13-ES (EUCTR) | 25/03/2014 | 28/01/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: ABP 501 Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1350 | EUCTR2013-005001-31-ES (EUCTR) | 25/03/2014 | 07/02/2014 | Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease. | Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Zoledronic acid Product Name: Zoledronic acid INN or Proposed INN: ZOLEDRONIC ACID | Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain | |||
| 1351 | EUCTR2010-020992-21-DE (EUCTR) | 25/03/2014 | 08/07/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina | ||
| 1352 | EUCTR2010-019262-86-NO (EUCTR) | 24/03/2014 | 08/10/2010 | Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 1940 | Phase 3 | United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1353 | EUCTR2013-000525-31-RO (EUCTR) | 24/03/2014 | 12/02/2015 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1354 | EUCTR2013-004555-21-PT (EUCTR) | 24/03/2014 | 07/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 1355 | EUCTR2013-003780-65-IT (EUCTR) | 24/03/2014 | 03/12/2013 | Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis | A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 14.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | France;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy | ||
| 1356 | EUCTR2013-003780-65-HU (EUCTR) | 19/03/2014 | 21/01/2014 | Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis | A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitorsRevised Protocol Number 02 incorporating Amendment 06 andAdministrative Letter 02 | Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | France;United States;Hungary;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy | ||
| 1357 | EUCTR2012-003686-17-GR (EUCTR) | 18/03/2014 | 16/01/2014 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1358 | EUCTR2012-003194-25-HR (EUCTR) | 17/03/2014 | 03/09/2014 | Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Mabion S.A. | NULL | Not Recruiting | Female: yes Male: yes | 863 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia | ||
| 1359 | JPRN-UMIN000013362 | 2014/03/15 | 06/03/2014 | Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. | Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. - PRESERVATION OF REMISSION MAINTAENANCE BY LOW DOSE ETANERCEPT | Rheumatoid Arthritis | Methotrexate Etanercept | Takarazuka city hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 1360 | NCT02092467 (ClinicalTrials.gov) | March 14, 2014 | 3/3/2014 | Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: tofacitinib;Biological: adalimumab;Biological: etanercept | Pfizer | NULL | Completed | 50 Years | N/A | All | 4372 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden |
| 1361 | EUCTR2013-002358-57-ES (EUCTR) | 11/03/2014 | 05/12/2013 | A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Spain;Australia;Netherlands;United Kingdom | ||
| 1362 | EUCTR2013-001492-20-PT (EUCTR) | 05/03/2014 | 24/01/2014 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Spain;Ireland;United Kingdom | ||
| 1363 | ChiCTR-TCS-14004252 | 2014-03-04 | 2014-02-12 | A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid | A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid | osteoarthritis, rheumatoid arthritis, lower back pain, joint/muscle pain | case series:Norspan 5mg patch (1 patch per week), and the dose can be titrated up to maximum 40mg patch in the titration period (maximun 42 days). Patient will then be using the optimum dosage for 11 weeks, and follow-up for another 2 weeks after treatment period, maximum 19 weeks; | The Chinese University of Hong Kong | NULL | Pending | 18 | 80 | Both | case series:15; | I (Phase 1 study) | NULL |
| 1364 | NCT02046603 (ClinicalTrials.gov) | March 4, 2014 | 24/1/2014 | A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent | Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 162 | Phase 3 | United Kingdom |
| 1365 | EUCTR2013-004555-21-LV (EUCTR) | 03/03/2014 | 02/01/2014 | This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | CELLTRION, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 361 | Phase 3 | Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina | ||
| 1366 | NCT02029599 (ClinicalTrials.gov) | March 2014 | 26/12/2013 | The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis | A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Fang yi qing feng shi granule;Drug: placebo;Drug: Methotrexate;Drug: Acetaminophen tablets | Maoxiang Group Jilin Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 65 Years | Both | 240 | Phase 2 | China |
| 1367 | EUCTR2012-003635-31-AT (EUCTR) | 26/02/2014 | 02/07/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1368 | EUCTR2013-004051-20-ES (EUCTR) | 26/02/2014 | 27/12/2013 | NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY | NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY | RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: ROACTEMRA | FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | Spain | ||
| 1369 | EUCTR2012-003654-86-AT (EUCTR) | 26/02/2014 | 08/07/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Spain;Guatemala;Ukraine;Lithuania;Austria;Israel;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1370 | EUCTR2012-001176-10-DE (EUCTR) | 24/02/2014 | 05/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1371 | EUCTR2013-004654-13-HU (EUCTR) | 24/02/2014 | 14/01/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Bulgaria;Germany;United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania | |||
| 1372 | EUCTR2012-003655-11-HU (EUCTR) | 24/02/2014 | 11/11/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 1373 | EUCTR2013-002007-34-SE (EUCTR) | 20/02/2014 | 23/01/2014 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 1374 | EUCTR2012-001176-10-PT (EUCTR) | 18/02/2014 | 09/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1375 | EUCTR2013-004654-13-GB (EUCTR) | 12/02/2014 | 17/01/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1376 | EUCTR2013-004654-13-CZ (EUCTR) | 12/02/2014 | 03/01/2014 | The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis | An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1377 | EUCTR2013-002007-34-FI (EUCTR) | 10/02/2014 | 14/11/2013 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 1378 | JPRN-UMIN000016844 | 2014/02/07 | 20/03/2015 | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors - The aggressive clinical tight control study(TACTICS trial) | Rheumatoid arthritis | infliximab: standard strategy infliximab: aggressive strategy golimumab: standard strategy golimumab: aggressive strategy | Takarazuka city hospital | NULL | Recruiting | 20years-old | 90years-old | Male and Female | 80 | Not applicable | Japan |
| 1379 | EUCTR2013-002358-57-HU (EUCTR) | 05/02/2014 | 21/12/2013 | A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom | ||
| 1380 | JPRN-JapicCTI-142505 | 01/2/2014 | Phase III study of MRA-SC 162 mg/week | A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks | Rheumatoid arthritis | Intervention name : MRA-SC INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg QW Control intervention name : MRA-SC INN of the control intervention : tocilizumab Dosage And administration of the control intervention : 162 mg Q2W | Chugai Pharmaceutical Co., Ltd. | NULL | 20 | BOTH | 50 | Phase 3 | NULL | |||
| 1381 | EUCTR2013-002777-22-DK (EUCTR) | 31/01/2014 | 11/12/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||
| 1382 | EUCTR2013-001492-20-ES (EUCTR) | 31/01/2014 | 16/01/2014 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Spain;Ireland;United Kingdom | ||
| 1383 | EUCTR2013-002777-22-ES (EUCTR) | 31/01/2014 | 02/12/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||
| 1384 | NCT02169544 (ClinicalTrials.gov) | January 31, 2014 | 14/5/2014 | Post-marketing Study Assessing the Long-Term Safety of Abatacept | Post-marketing Study Assessing the Long-Term Safety of Abatacept | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 100000 | N/A | NULL |
| 1385 | NCT01987479 (ClinicalTrials.gov) | January 30, 2014 | 8/11/2013 | A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis | Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR | Rheumatoid Arthritis | Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 150 | Phase 3 | Netherlands |
| 1386 | EUCTR2013-002777-22-HU (EUCTR) | 28/01/2014 | 28/11/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||
| 1387 | NCT02049138 (ClinicalTrials.gov) | January 24, 2014 | 28/1/2014 | An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects | A Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494) | Rheumatoid Arthritis | Drug: ABT-494 | AbbVie | NULL | Completed | 18 Years | 100 Years | All | 494 | Phase 2 | New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Belgium;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;United States;Australia;Czech Republic |
| 1388 | EUCTR2012-003655-11-BE (EUCTR) | 23/01/2014 | 15/10/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of;United States;Czechia;Spain;Guatemala | ||
| 1389 | EUCTR2012-001176-10-IT (EUCTR) | 22/01/2014 | 28/10/2013 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 1390 | EUCTR2011-005689-39-DE (EUCTR) | 20/01/2014 | 24/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 1391 | EUCTR2012-001176-10-BE (EUCTR) | 14/01/2014 | 23/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1392 | EUCTR2012-001176-10-AT (EUCTR) | 13/01/2014 | 13/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia | ||
| 1393 | EUCTR2010-019262-86-GB (EUCTR) | 13/01/2014 | 16/10/2013 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 3 | Portugal;Belarus;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1394 | JPRN-UMIN000012364 | 2014/01/10 | 25/11/2013 | Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. | Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. - Research for an appropriate use of tramadol / acetaminophen combination tablets for patient with rheumatoid arthritis. | rheumatoid arthritis | Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief. Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows; *Day1-Day7(1 tablet/day, after night meal) *Day8-Day14(1 tabletX2 times /day, after morning and night meal) *Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal *Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime) Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks. | Osaka City University Medical School, Department of Orthopedic Surgery | NULL | Complete: follow-up complete | 25years-old | 75years-old | Male and Female | 31 | Not applicable | Japan |
| 1395 | EUCTR2013-000525-31-DE (EUCTR) | 10/01/2014 | 06/08/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1396 | EUCTR2012-001176-10-GB (EUCTR) | 10/01/2014 | 20/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1397 | ChiCTR1800019290 | 2014-01-01 | 2018-11-03 | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients | Rheumatoid Arthritis | Control group:MTX;Treatment group 1:ZA;Treatment group 2:MTX+ZA; | Xiao Lianbo | NULL | Completed | 18 | 65 | Both | Control group:22;Treatment group 1:22;Treatment group 2:22; | 2 (Phase 2 study) | China |
| 1398 | JPRN-JapicCTI-142497 | 01/1/2014 | Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors. | A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors. | Rheumatoid Arthritis | Intervention name : Clazakizumab Dosage And administration of the intervention : Injection, 1 mg, 5 mg, 25 mg Control intervention name : null | Bristol-Myers K.K. | NULL | 18 | BOTH | 140 | Phase 2 | NULL | |||
| 1399 | NCT02001987 (ClinicalTrials.gov) | January 2014 | 29/11/2013 | A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy | A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 139 | Phase 3 | France |
| 1400 | NCT02031471 (ClinicalTrials.gov) | January 2014 | 16/12/2013 | TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment | TOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 57 | Phase 3 | Belgium;Luxembourg |
| 1401 | NCT01988012 (ClinicalTrials.gov) | January 2014 | 31/10/2013 | A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis. | An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients. | Rheumatoid Arthritis | Biological: tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Israel |
| 1402 | EUCTR2012-003686-17-LT (EUCTR) | 31/12/2013 | 21/11/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1403 | JPRN-UMIN000012690 | 2013/12/28 | 27/12/2013 | Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment | Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment - STARR-SMARRT | Rheumatoid Arthritis | tocilizumab+tacrolimus+Bucillamine tocilizumab | National hospital organization Chiba east national hospital Clinical Research Center | NULL | Complete: follow-up complete | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan |
| 1404 | EUCTR2013-001492-20-GB (EUCTR) | 24/12/2013 | 18/10/2013 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 1405 | EUCTR2012-003655-11-LV (EUCTR) | 18/12/2013 | 08/11/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 1406 | EUCTR2013-004006-26-DK (EUCTR) | 18/12/2013 | 18/12/2013 | OPAL | Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan | Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging. MedDRA version: 16.1;Level: LLT;Classification code 10067132;Term: Synovitis wrist;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ICG-Pulsion INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt Other descriptive name: INDOCYANINE GREEN | Knowledge Centre for Rheumatology and Back Diseases | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 1407 | EUCTR2013-002777-22-DE (EUCTR) | 17/12/2013 | 22/11/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 4 | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||
| 1408 | EUCTR2013-002150-79-BE (EUCTR) | 16/12/2013 | 24/10/2013 | A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients | TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-02 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | N.V. Roche S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Belgium | ||
| 1409 | EUCTR2013-000525-31-BG (EUCTR) | 13/12/2013 | 21/11/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1410 | EUCTR2011-004720-35-IS (EUCTR) | 13/12/2013 | 06/12/2013 | NORD-STAR | A multicenter, randomized, single-blinded, phase 4 study in patients with early rheumatoid arthritis to compare 1) active conventional therapy versus three biologic treatments, and 2) two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Metoject | The Karolinska Instutute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Norway;Iceland;Sweden | |||
| 1411 | EUCTR2013-002007-34-DK (EUCTR) | 09/12/2013 | 09/12/2013 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 1412 | NCT01668966 (ClinicalTrials.gov) | December 9, 2013 | 16/8/2012 | A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA) | A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Months | N/A | All | 23 | Phase 3 | Brazil |
| 1413 | EUCTR2012-003686-17-HR (EUCTR) | 05/12/2013 | 01/09/2014 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1414 | EUCTR2012-003686-17-SE (EUCTR) | 02/12/2013 | 05/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1415 | JPRN-UMIN000012073 | 2013/12/01 | 21/10/2013 | Effects of Subcutaneous Actemura and MTX Blending in RA | Effects of Subcutaneous Actemura and MTX Blending in RA - eSCRAMBLE | rheumatoid arthritis | Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks. Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks. | Department of Orthopaedic Surgery,Graduate School of Medicine, Osaka City University Medical School | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 100 | Phase 4 | Japan |
| 1416 | NCT02047604 (ClinicalTrials.gov) | December 2013 | 22/1/2014 | (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s). | Rheumatoid Arthritis | Drug: SAN-300 0.5 mg/kg QW;Drug: SAN-300 1.0 mg/kg QW;Drug: SAN-300 2.0 mg/kg QOW;Drug: SAN-300 4.0 mg/kg QOW;Drug: SAN-300 4.0 mg/kg QW;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 41 | Phase 2 | United States |
| 1417 | EUCTR2013-000114-38-DE (EUCTR) | 29/11/2013 | 29/05/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1418 | NCT03736044 (ClinicalTrials.gov) | November 25, 2013 | 11/10/2018 | Reconstitution of CD4+CD25highCD127low/-Tcell | Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy | Rheumatoid Arthritis | Drug: TNF-blockers suspension in patients with rheumatoid arthritis | University Hospital of Ferrara | NULL | Completed | 18 Years | N/A | All | 48 | Phase 1 | NULL |
| 1419 | NCT01941095 (ClinicalTrials.gov) | November 20, 2013 | 30/8/2013 | A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis | Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Greece |
| 1420 | EUCTR2013-001999-38-PL (EUCTR) | 17/11/2013 | 11/10/2013 | A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of | ||
| 1421 | EUCTR2013-000525-31-PL (EUCTR) | 17/11/2013 | 10/10/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1422 | EUCTR2013-002777-22-GB (EUCTR) | 14/11/2013 | 07/10/2013 | Targeted Ultrasound in Rheumatoid Arthritis (TURA) | Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 4 | France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom | ||
| 1423 | EUCTR2013-003658-26-NL (EUCTR) | 13/11/2013 | 18/10/2013 | Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study | Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study | Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 1424 | JPRN-UMIN000012257 | 2013/11/12 | 11/11/2013 | Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial | Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial - Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial | osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle | A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 74 | Not selected | Japan |
| 1425 | EUCTR2013-003486-34-DK (EUCTR) | 04/11/2013 | 04/11/2013 | Treatment of Tenosynovitis among rheumatoid arthritis patients | Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN | MedDRA version: 16.0;Level: LLT;Classification code 10042869;Term: Synovitis and tenosynovitis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebarkhormon Trade Name: Natriumklorid 9mg/ml INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE | Knowledge Centre for Rheumatology and Back Diseases | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 1426 | NCT01990157 (ClinicalTrials.gov) | November 2013 | 5/11/2013 | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective | Rheumatoid Arthritis | Drug: TAB08 | Theramab LLC | NULL | Completed | 18 Years | 65 Years | All | 18 | Phase 1/Phase 2 | Russian Federation |
| 1427 | NCT01980836 (ClinicalTrials.gov) | November 2013 | 4/11/2013 | Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine | The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis;Cellular Immune Response | Biological: Seasonal influenza vaccine | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 18 Years | N/A | Both | 40 | Phase 4 | Israel |
| 1428 | NCT02005757 (ClinicalTrials.gov) | November 2013 | 4/12/2013 | Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED) | Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug | Rheumatoid Arthritis | Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg | Chong Kun Dang Pharmaceutical | NULL | Recruiting | 20 Years | 80 Years | Both | 60 | Phase 2 | Korea, Republic of |
| 1429 | NCT01951170 (ClinicalTrials.gov) | November 2013 | 23/9/2013 | An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis | An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 52 | Phase 3 | Australia |
| 1430 | NCT02254655 (ClinicalTrials.gov) | November 2013 | 18/11/2013 | The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis | The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial | Rheumatoid Arthritis | Drug: Puerarin injection 400 mg;Drug: Control | Chengdu PLA General Hospital | NULL | Completed | 18 Years | 75 Years | All | 119 | Phase 2 | China |
| 1431 | NCT01855789 (ClinicalTrials.gov) | November 2013 | 14/5/2013 | A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 718 | Phase 3 | United States | |
| 1432 | EUCTR2012-001176-10-ES (EUCTR) | 31/10/2013 | 05/09/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 1433 | EUCTR2012-004074-25-DE (EUCTR) | 30/10/2013 | 29/07/2013 | Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis | Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA | Early rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon | Ruhr-Universität Bochum | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Germany | ||
| 1434 | EUCTR2013-001999-38-HU (EUCTR) | 30/10/2013 | 16/07/2013 | A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid | Neovacs SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Serbia;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of | ||
| 1435 | EUCTR2013-001999-38-CZ (EUCTR) | 30/10/2013 | 24/07/2013 | A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of | ||
| 1436 | EUCTR2013-002341-11-GB (EUCTR) | 25/10/2013 | 26/07/2013 | This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell | A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS | healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | Phase 4 | United Kingdom | |||
| 1437 | EUCTR2012-003686-17-GB (EUCTR) | 24/10/2013 | 06/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1438 | EUCTR2013-000342-19-NL (EUCTR) | 24/10/2013 | 08/10/2013 | A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug. | MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Nederland B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 1439 | EUCTR2013-000114-38-BG (EUCTR) | 23/10/2013 | 09/09/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1440 | EUCTR2013-002429-52-IE (EUCTR) | 23/10/2013 | 15/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab SC Other descriptive name: TOCILIZUMAB SC | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 1441 | EUCTR2013-000525-31-CZ (EUCTR) | 21/10/2013 | 17/07/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1442 | EUCTR2013-002429-52-PT (EUCTR) | 21/10/2013 | 08/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 1443 | EUCTR2012-003724-20-RO (EUCTR) | 14/10/2013 | 28/07/2014 | A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate. | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145 Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145 Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145 | Infinity Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 316 | Phase 2 | Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand | ||
| 1444 | EUCTR2013-000525-31-ES (EUCTR) | 12/10/2013 | 01/08/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1445 | NCT01894516 (ClinicalTrials.gov) | October 8, 2013 | 4/7/2013 | Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2) | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone | Rheumatoid Arthritis | Drug: GLPG0634;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 287 | Phase 2 | United States;Argentina;Australia;Austria;Bulgaria;Chile;Colombia;Germany;Guatemala;Hungary;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine |
| 1446 | EUCTR2013-001999-38-BE (EUCTR) | 07/10/2013 | 11/07/2013 | A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of | ||
| 1447 | EUCTR2013-000054-22-GB (EUCTR) | 01/10/2013 | 07/08/2013 | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R | Roche Products Limited | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom | |||
| 1448 | JPRN-UMIN000011891 | 2013/10/01 | 01/10/2013 | Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. | Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. - GLORIA study | Rheumatoid Arthritis | Golimumab | St.Marianna University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 50 | Not selected | Japan |
| 1449 | JPRN-JapicCTI-132277 | 01/10/2013 | AMG 162 Phase III study (DESIRABLE study) | A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) | rheumatoid arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection Control intervention name : Placebo Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection | DAIICHISANKYO Co.,Ltd. | NULL | 20 | BOTH | 642 | Phase 3 | NULL | |||
| 1450 | NCT01975610 (ClinicalTrials.gov) | October 2013 | 29/10/2013 | Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis | A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CC-292;Drug: Placebo | Celgene | NULL | Completed | 18 Years | 80 Years | Female | 47 | Phase 2 | United States |
| 1451 | NCT01773681 (ClinicalTrials.gov) | October 2013 | 16/1/2013 | Novel Imaging Markers for Rheumatoid Arthritis | Novel Imaging Markers for Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Cimzia;Device: Magnetic Resonance Imaging (MRI);Device: High-resolution peripheral quantitative computed tomography (HR-pQCT) | University of California, San Francisco | NULL | Completed | 18 Years | N/A | All | 30 | United States | |
| 1452 | NCT01985464 (ClinicalTrials.gov) | October 2013 | 31/10/2013 | Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis | Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Umbilical cord mesenchymal stem cells | Translational Biosciences | NULL | Unknown status | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Panama |
| 1453 | NCT01966718 (ClinicalTrials.gov) | October 2013 | 14/10/2013 | Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies. | Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action | Rheumatoid Arthritis | Drug: Repository corticotropin injection | Arthritis Treatment Center, Maryland | NULL | Completed | 18 Years | 80 Years | All | 8 | Phase 4 | United States |
| 1454 | NCT01960855 (ClinicalTrials.gov) | October 2013 | 9/10/2013 | A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 276 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Hungary;Netherlands;New Zealand;Poland;Puerto Rico;Spain;United Kingdom;United States |
| 1455 | NCT01962337 (ClinicalTrials.gov) | October 2013 | 10/10/2013 | A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis | A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis | Healthy;Rheumatoid Arthritis | Drug: FPA008;Drug: Placebo | Five Prime Therapeutics, Inc. | NULL | Terminated | 21 Years | 70 Years | All | 66 | Phase 1 | Hungary;Netherlands;Poland |
| 1456 | NCT01973569 (ClinicalTrials.gov) | October 2013 | 25/10/2013 | AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment | A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III) | Rheumatoid Arthritis | Drug: denosumab;Drug: placebo | Daiichi Sankyo, Inc. | NULL | Completed | 20 Years | N/A | All | 679 | Phase 3 | Japan |
| 1457 | NCT01962974 (ClinicalTrials.gov) | October 2013 | 11/10/2013 | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | Arthritis, Rheumatoid | Biological: Golimumab 2 mg/kg IV | Janssen Biotech, Inc. | NULL | Terminated | 18 Years | 76 Years | All | 7 | Phase 3 | United States;Canada;Argentina;Brazil;Colombia;Mexico |
| 1458 | NCT01970475 (ClinicalTrials.gov) | October 2013 | 23/10/2013 | Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: ABP 501;Biological: Adalimumab | Amgen | NULL | Completed | 18 Years | 80 Years | All | 526 | Phase 3 | United States;Canada;Germany;United Kingdom;Bulgaria;Czech Republic;Hungary;Mexico;Poland;Romania;Russian Federation;Spain |
| 1459 | EUCTR2012-003635-31-BG (EUCTR) | 27/09/2013 | 25/09/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1460 | EUCTR2013-000525-31-HU (EUCTR) | 26/09/2013 | 30/09/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1461 | EUCTR2012-003654-86-DE (EUCTR) | 26/09/2013 | 03/06/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1462 | EUCTR2013-000114-38-SK (EUCTR) | 25/09/2013 | 03/07/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1463 | EUCTR2013-000114-38-HU (EUCTR) | 19/09/2013 | 12/06/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1464 | EUCTR2013-000944-25-HU (EUCTR) | 19/09/2013 | 16/07/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis | A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan | |||
| 1465 | EUCTR2012-005733-37-GB (EUCTR) | 18/09/2013 | 23/07/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 1466 | EUCTR2012-005674-61-LV (EUCTR) | 13/09/2013 | 13/09/2013 | Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis | A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS | Mesoblast, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Serbia;Hungary;Estonia;Czech Republic;Belgium;Poland;Croatia;Latvia | |||
| 1467 | EUCTR2013-000359-42-GR (EUCTR) | 12/09/2013 | 27/08/2013 | Not applicable | Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 | ROCHE HELLAS S.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Greece | |||
| 1468 | EUCTR2012-005674-61-EE (EUCTR) | 12/09/2013 | 02/09/2013 | Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis | A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS | Mesoblast, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Serbia;Hungary;Czech Republic;Estonia;Belgium;Poland;Croatia;Latvia | ||
| 1469 | EUCTR2012-005674-61-BE (EUCTR) | 11/09/2013 | 30/08/2013 | Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis | A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS | Mesoblast, Inc | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia | ||
| 1470 | EUCTR2012-001984-66-NO (EUCTR) | 11/09/2013 | 17/10/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | Phase 3 | United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Germany;Norway;New Zealand | ||
| 1471 | NCT01907230 (ClinicalTrials.gov) | September 10, 2013 | 14/7/2013 | Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients | Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial | Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus | Drug: Entecavir | Taipei Veterans General Hospital, Taiwan | NULL | Active, not recruiting | 20 Years | 90 Years | All | 115 | Phase 4 | Taiwan |
| 1472 | EUCTR2012-001176-10-LT (EUCTR) | 09/09/2013 | 20/06/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 1473 | EUCTR2013-000114-38-LT (EUCTR) | 09/09/2013 | 02/07/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1474 | EUCTR2012-003635-31-DE (EUCTR) | 05/09/2013 | 30/04/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1475 | NCT01941940 (ClinicalTrials.gov) | September 5, 2013 | 2/9/2013 | A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants | A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: DMARDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 227 | Phase 3 | Italy |
| 1476 | EUCTR2013-000114-38-CZ (EUCTR) | 04/09/2013 | 12/06/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1477 | EUCTR2012-003654-86-ES (EUCTR) | 03/09/2013 | 12/07/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Germany;Latvia;New Zealand | ||
| 1478 | EUCTR2012-003635-31-LV (EUCTR) | 02/09/2013 | 06/08/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1479 | JPRN-JapicCTI-132209 | 01/9/2013 | Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E) | A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : Secukinumab Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c. Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | 454 | Phase 3 | NULL | |||
| 1480 | ChiCTR-ONRC-13003578 | 2013-09-01 | 2013-09-09 | Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study | Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study | Rheumatoid arthritis | The water decoction group of Agkistrodon:Taking the water decoction of Agkistrodon;Agkistrodon liquor:Taking Agkistrodon liquor agents;Agkistrodon pulvis:Taking the Agkistrodon pulvis;Control group:Taking placebo; | Zhejiang Chinese Medical University | NULL | Completed | 18 | 65 | Both | The water decoction group of Agkistrodon:30;Agkistrodon liquor:30;Agkistrodon pulvis:30;Control group:30; | I (Phase 1 study) | China |
| 1481 | NCT01955603 (ClinicalTrials.gov) | September 2013 | 24/9/2013 | A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis | A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0215-0384;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | Both | 24 | Phase 1 | Germany;Hungary;Poland;Russian Federation |
| 1482 | NCT01787149 (ClinicalTrials.gov) | September 2013 | 6/2/2013 | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis | Combination With DMARDs | Drug: DMARDs | Mycenax Biotech Inc. | NULL | Unknown status | 20 Years | N/A | All | 98 | Phase 3 | Taiwan |
| 1483 | NCT02600468 (ClinicalTrials.gov) | September 2013 | 6/11/2015 | Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg | Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Completed | 18 Years | N/A | All | 671 | N/A | NULL |
| 1484 | NCT01783015 (ClinicalTrials.gov) | September 2013 | 31/1/2013 | Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate | A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate | Rheumatoid Arthritis | Drug: Etanercept;Drug: Placebo | Pfizer | NULL | Terminated | 18 Years | 79 Years | All | 16 | Phase 4 | Australia;Belgium;France;Hong Kong;Israel;Russian Federation;Spain;Netherlands |
| 1485 | NCT01901900 (ClinicalTrials.gov) | September 2013 | 10/7/2013 | Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA. | A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Secukinumab (AIN457) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 196 | Phase 3 | United States;Argentina;Canada;Guatemala;Hungary;India;Italy;Japan;Mexico;Thailand;Colombia;Panama;Puerto Rico |
| 1486 | NCT01995201 (ClinicalTrials.gov) | September 2013 | 1/11/2013 | A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis | A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | Both | 401 | Phase 3 | Ireland;Portugal;Spain |
| 1487 | NCT01948388 (ClinicalTrials.gov) | September 2013 | 9/9/2013 | The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients | Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging | Rheumatoid Arthritis | Drug: corticotrophin 80 units | Gaylis, Norman B., M.D. | NULL | Completed | 18 Years | N/A | All | 20 | Phase 4 | United States |
| 1488 | NCT01911234 (ClinicalTrials.gov) | September 2013 | 23/7/2013 | Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Biological: TNF-Kinoid;Other: Placebo | Neovacs | NULL | Completed | 18 Years | 75 Years | All | 143 | Phase 2 | Belgium;Georgia;Hungary;Lebanon;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Poland;Russian Federation;Serbia;Ukraine;Czech Republic |
| 1489 | NCT02072200 (ClinicalTrials.gov) | September 2013 | 14/2/2014 | Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) | A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness | Rheumatoid Arthritis | Drug: Lodotra® | Mundipharma Korea Ltd | NULL | Completed | 20 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 1490 | NCT02275299 (ClinicalTrials.gov) | September 2013 | 23/10/2014 | Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Leflunomide;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | Both | 240 | Phase 4 | China |
| 1491 | EUCTR2012-003635-31-CZ (EUCTR) | 28/08/2013 | 31/05/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1492 | EUCTR2013-000525-31-GB (EUCTR) | 27/08/2013 | 02/07/2013 | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany | ||
| 1493 | EUCTR2012-004342-14-DK (EUCTR) | 27/08/2013 | 19/04/2013 | A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2;Phase 3 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1494 | EUCTR2013-002429-52-ES (EUCTR) | 23/08/2013 | 12/07/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 1495 | EUCTR2012-004090-16-NL (EUCTR) | 20/08/2013 | 02/05/2013 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 | Boehringer Ingelheim B.V | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Poland;Spain;Germany;Netherlands;New Zealand | |||
| 1496 | EUCTR2011-005649-10-DE (EUCTR) | 19/08/2013 | 18/07/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1497 | EUCTR2012-002181-12-SE (EUCTR) | 19/08/2013 | 09/07/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden | ||
| 1498 | EUCTR2012-005733-37-CZ (EUCTR) | 16/08/2013 | 15/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 1499 | EUCTR2012-003654-86-HU (EUCTR) | 15/08/2013 | 17/05/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1500 | EUCTR2012-005026-30-HU (EUCTR) | 15/08/2013 | 20/02/2013 | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||
| 1501 | EUCTR2012-002181-12-AT (EUCTR) | 08/08/2013 | 25/06/2013 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 Other descriptive name: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck) | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden | ||
| 1502 | EUCTR2011-005689-39-CZ (EUCTR) | 07/08/2013 | 23/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 1503 | EUCTR2013-000114-38-EE (EUCTR) | 06/08/2013 | 13/06/2013 | A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) | A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b) | Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden | ||
| 1504 | EUCTR2010-020892-22-NL (EUCTR) | 03/08/2013 | 10/08/2011 | Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X) | A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 2000 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | |||
| 1505 | EUCTR2012-000439-17-LV (EUCTR) | 02/08/2013 | 05/06/2013 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: MK-8457 Product Code: MK-8457 | MERCK SHARP & DOHME CORP. | NULL | Not Recruiting | Female: yes Male: yes | 434 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan | ||
| 1506 | EUCTR2012-005733-37-LV (EUCTR) | 02/08/2013 | 22/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 1507 | EUCTR2013-000944-25-IT (EUCTR) | 02/08/2013 | 06/06/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis | A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 454 | Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan | |||
| 1508 | EUCTR2013-001569-17-IT (EUCTR) | 02/08/2013 | 04/06/2013 | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients. | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | Roche S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Italy | ||
| 1509 | NCT01936181 (ClinicalTrials.gov) | August 2013 | 2/9/2013 | A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab) | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 584 | Phase 3 | Bulgaria;Lithuania |
| 1510 | NCT01925157 (ClinicalTrials.gov) | August 2013 | 15/8/2013 | A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA) | A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: LY3090106 - SQ;Biological: LY3090106 - IV;Biological: Placebo - SQ | Eli Lilly and Company | NULL | Completed | 18 Years | 80 Years | Both | 43 | Phase 1 | Bulgaria;Moldova, Republic of;Poland;Romania;Hungary;United States |
| 1511 | NCT01905735 (ClinicalTrials.gov) | August 2013 | 19/7/2013 | A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis | A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis . | Rheumatoid Arthritis. | Drug: Rhustoxicodendron 30;Drug: placebo | Healthcare Homoeo Charitable Society | NULL | Recruiting | 25 Years | 60 Years | Both | 60 | Phase 2 | India |
| 1512 | NCT01394913 (ClinicalTrials.gov) | August 2013 | 12/7/2011 | Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis | A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Reumatocept (etanercept);Drug: Enbrel (etanercept) | EMS | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 3 | Brazil |
| 1513 | NCT01932372 (ClinicalTrials.gov) | July 26, 2013 | 30/7/2013 | Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis | XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE) | Rheumatoid Arthritis | Drug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc | Pfizer | NULL | Completed | N/A | N/A | All | 9968 | Japan | |
| 1514 | EUCTR2012-003686-17-LV (EUCTR) | 24/07/2013 | 05/07/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1515 | EUCTR2012-003686-17-PL (EUCTR) | 24/07/2013 | 04/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 1516 | EUCTR2012-003635-31-ES (EUCTR) | 23/07/2013 | 10/06/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | Latvia;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru | ||
| 1517 | EUCTR2012-003686-17-BE (EUCTR) | 18/07/2013 | 31/05/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia | ||
| 1518 | NCT01888874 (ClinicalTrials.gov) | July 17, 2013 | 26/6/2013 | Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: GLPG0634;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 599 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Russian Federation;Spain;Ukraine;Czech Republic;Peru;Puerto Rico |
| 1519 | EUCTR2012-002323-15-HR (EUCTR) | 17/07/2013 | 30/03/2015 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1520 | EUCTR2011-005648-93-GB (EUCTR) | 12/07/2013 | 30/05/2013 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Protocol Ref: CD-IA-CAM-3001-1109 - An Open-label of Mavrilimumab in Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany | ||
| 1521 | EUCTR2012-003686-17-HU (EUCTR) | 11/07/2013 | 07/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1522 | EUCTR2012-005733-37-LT (EUCTR) | 11/07/2013 | 20/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 1523 | EUCTR2012-005733-37-BG (EUCTR) | 10/07/2013 | 21/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 1524 | EUCTR2012-003635-31-HU (EUCTR) | 09/07/2013 | 22/04/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1525 | EUCTR2012-003644-71-BE (EUCTR) | 08/07/2013 | 06/02/2013 | Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure | A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand | ||
| 1526 | EUCTR2011-005648-93-PT (EUCTR) | 05/07/2013 | 03/04/2013 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany | |||
| 1527 | EUCTR2011-005649-10-GB (EUCTR) | 05/07/2013 | 11/03/2013 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1528 | EUCTR2012-003686-17-ES (EUCTR) | 04/07/2013 | 26/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 3000 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1529 | EUCTR2012-003686-17-DK (EUCTR) | 04/07/2013 | 07/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1530 | EUCTR2012-003686-17-DE (EUCTR) | 04/07/2013 | 13/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 1531 | EUCTR2012-001984-66-LV (EUCTR) | 03/07/2013 | 25/04/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1532 | EUCTR2012-001984-66-IT (EUCTR) | 02/07/2013 | 07/05/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1533 | JPRN-JapicCTI-153073 | 01/7/2013 | 18/11/2015 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) | Rheumatoid arthritis | Intervention name : Sirukumab Dosage And administration of the intervention : 100 mg Intervention name : Sirukuma Dosage And administration of the intervention : 50mg Control intervention name : null | Janssen Pharmaceutical K.K. | NULL | 18 | BOTH | 280 | Phase 3 | NULL | ||
| 1534 | EUCTR2012-003223-38-DE (EUCTR) | 01/07/2013 | 08/04/2013 | Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials. | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 | RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 157 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | ||
| 1535 | NCT01853033 (ClinicalTrials.gov) | July 2013 | 10/5/2013 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis | A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122 | Rheumatoid Arthritis | Biological: ABT-122;Biological: Placebo | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 19 | Phase 1 | United States |
| 1536 | NCT01864265 (ClinicalTrials.gov) | July 2013 | 21/5/2013 | Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain | Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain. A Multi-center, Randomized Double-blind Controlled Study Prediction of Response to Certolizumab-Pegol in RA (PreCePRA) | Rheumatoid Arthritis | Drug: Certolizumab Pegol;Drug: Placebo | University of Erlangen-Nürnberg Medical School | NULL | Completed | 18 Years | N/A | All | 156 | Phase 3 | Germany;Portugal;Serbia;Belgium;United Kingdom;United States |
| 1537 | NCT02519387 (ClinicalTrials.gov) | July 2013 | 15/7/2015 | Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity | Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia | Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain | Drug: Buprenorphine Transdermal Patch | Mundipharma Pharmaceuticals Sdn. Bhd. | NULL | Completed | 40 Years | N/A | All | 78 | Phase 4 | Malaysia |
| 1538 | NCT01890473 (ClinicalTrials.gov) | July 2013 | 27/6/2013 | Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe | Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 356 | Phase 1 | United States;Argentina;Mexico;Peru;South Africa |
| 1539 | NCT01927263 (ClinicalTrials.gov) | July 2013 | 9/8/2013 | A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis | A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study? | Rheumatoid Arthritis | Biological: NI-071;Biological: Infliximab | Nichi-Iko Pharmaceutical Co.,Ltd. | NULL | Completed | 20 Years | 75 Years | Both | 242 | Phase 3 | Japan |
| 1540 | NCT02236481 (ClinicalTrials.gov) | July 2013 | 8/9/2014 | Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes | No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study | Diabetes Mellitus, Type 2;Arthritis, Rheumatoid | Drug: Anakinra;Drug: TNF alpha inhibitors | Prof. Roberto Giacomelli | NULL | Terminated | 18 Years | N/A | All | 41 | Phase 4 | Italy |
| 1541 | NCT02894047 (ClinicalTrials.gov) | July 2013 | 5/9/2016 | Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years | Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years | Arthritis, Rheumatoid | Biological: blood | Centre Hospitalier Universitaire, Amiens | NULL | Completed | 18 Years | N/A | Both | 42 | N/A | France |
| 1542 | NCT01862224 (ClinicalTrials.gov) | July 2013 | 2/5/2013 | A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: JNJ-38518168;Drug: Placebo;Drug: Placebo / JNJ-38518168 | Janssen Research & Development, LLC | NULL | Terminated | 18 Years | 65 Years | Both | 21 | Phase 2 | United States;Moldova, Republic of |
| 1543 | EUCTR2011-005689-39-HU (EUCTR) | 27/06/2013 | 22/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 1544 | EUCTR2012-004090-16-CZ (EUCTR) | 27/06/2013 | 14/02/2013 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 INN or Proposed INN: BI 655064 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 1;Phase 2 | Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand | ||
| 1545 | NCT01885078 (ClinicalTrials.gov) | June 27, 2013 | 19/6/2013 | An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 2877 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Czech Republic |
| 1546 | EUCTR2011-005689-39-ES (EUCTR) | 26/06/2013 | 24/06/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 1547 | EUCTR2012-003635-31-BE (EUCTR) | 26/06/2013 | 03/04/2013 | Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone | Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone. | moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 595 | Phase 2 | United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 1548 | EUCTR2012-001984-66-DE (EUCTR) | 26/06/2013 | 06/03/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand | |||
| 1549 | EUCTR2012-003686-17-NL (EUCTR) | 26/06/2013 | 25/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3000 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 1550 | EUCTR2012-001984-66-LT (EUCTR) | 20/06/2013 | 23/04/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1551 | EUCTR2012-004482-40-ES (EUCTR) | 18/06/2013 | 16/05/2013 | Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized. | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: ENBREL Product Name: Etanercept INN or Proposed INN: ETANERCEPT Trade Name: CIMZIA Product Name: Certolizumab Pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: SIMPONI Product Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | FRANCISCO J. BLANCO GARCÍA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 1552 | EUCTR2012-003686-17-CZ (EUCTR) | 17/06/2013 | 31/05/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1553 | EUCTR2012-003724-20-DE (EUCTR) | 13/06/2013 | 04/02/2013 | A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate. | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 | Infinity Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 316 | Phase 2 | Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Colombia;Germany;New Zealand | ||
| 1554 | EUCTR2012-003686-17-PT (EUCTR) | 12/06/2013 | 14/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 1555 | EUCTR2012-003686-17-AT (EUCTR) | 11/06/2013 | 07/06/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3350 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1556 | NCT01901185 (ClinicalTrials.gov) | June 11, 2013 | 17/5/2013 | Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept | A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Etanercept / Autoinjector A | Amgen | NULL | Completed | 18 Years | N/A | All | 77 | Phase 3 | United States |
| 1557 | EUCTR2012-003686-17-FR (EUCTR) | 07/06/2013 | 21/09/2015 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3000 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 1558 | EUCTR2012-001984-66-HU (EUCTR) | 06/06/2013 | 14/03/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - SARIL-RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1559 | EUCTR2012-003686-17-SK (EUCTR) | 05/06/2013 | 02/05/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 3000 | Phase 3 | Croatia;Germany;Japan;Sweden;Canada;Argentina;Brazil;Belgium;Poland;Romania;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico | ||
| 1560 | EUCTR2012-003536-23-PL (EUCTR) | 05/06/2013 | 22/04/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden | |||
| 1561 | NCT01875991 (ClinicalTrials.gov) | June 5, 2013 | 10/6/2013 | Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept | An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept | Rheumatoid Arthritis;Plaque Psoriasis | Drug: Etanercept via Autoinjector A;Drug: Etanercept via Autoinjector B | Amgen | NULL | Completed | 18 Years | N/A | All | 217 | Phase 4 | United States;Canada |
| 1562 | NCT01895309 (ClinicalTrials.gov) | June 2013 | 3/7/2013 | A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Enbrel (etanercept);Drug: SB4 (proposed biosimilar to etanercept) | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 596 | Phase 3 | Poland;United Kingdom |
| 1563 | NCT01909427 (ClinicalTrials.gov) | June 2013 | 10/7/2013 | An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: CNTO 6785 200 mg;Drug: CNTO 6785 100 mg;Drug: CNTO 6785 50 mg;Drug: CNTO 6785 15 mg | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 80 Years | Both | 257 | Phase 2 | Argentina;Colombia;Czech Republic;Philippines;Poland;Russian Federation;Thailand |
| 1564 | NCT01885819 (ClinicalTrials.gov) | June 2013 | 18/6/2013 | Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis | Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Autologous stromal vascular fraction cells | Translational Biosciences | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | Panama |
| 1565 | NCT01878318 (ClinicalTrials.gov) | June 2013 | 6/6/2013 | A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs | Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs | Rheumatoid Arthritis | Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Venezuela |
| 1566 | NCT01955733 (ClinicalTrials.gov) | May 31, 2013 | 30/9/2013 | Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis | Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial | Arthritis, Rheumatoid | Drug: BI 695500 | Boehringer Ingelheim | NULL | Terminated | 18 Years | 82 Years | All | 91 | Phase 3 | United States;Belgium;Bulgaria;Germany;Greece;Netherlands;Poland;Portugal;Spain;Argentina;Brazil;Canada;Chile;Hungary;Ireland;Mexico;United Kingdom |
| 1567 | EUCTR2012-003686-17-IT (EUCTR) | 29/05/2013 | 04/04/2013 | A Phase 3 Study in Rheumatoid Arthritis | A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3000 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 1568 | JPRN-UMIN000014485 | 2013/05/24 | 01/12/2014 | Golimumab study for development of tight control and biologics-free condition. | Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study | rheumatoid arthritis | Treatment with Golimumab for patients with rheumatoid arthritis | Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 1569 | EUCTR2012-000610-11-CZ (EUCTR) | 22/05/2013 | 20/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 298 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1570 | EUCTR2012-000609-58-CZ (EUCTR) | 22/05/2013 | 21/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1571 | EUCTR2012-003536-23-GB (EUCTR) | 21/05/2013 | 15/03/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | ||
| 1572 | EUCTR2012-003724-20-BG (EUCTR) | 20/05/2013 | 20/03/2013 | A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate. | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 | Infinity Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 316 | Phase 2 | Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand | ||
| 1573 | EUCTR2012-001984-66-FI (EUCTR) | 17/05/2013 | 24/04/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1574 | EUCTR2012-005026-30-PL (EUCTR) | 17/05/2013 | 08/03/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 1575 | EUCTR2012-002339-27-ES (EUCTR) | 16/05/2013 | 16/05/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1576 | EUCTR2012-001984-66-GR (EUCTR) | 15/05/2013 | 23/04/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1577 | EUCTR2012-005026-30-CZ (EUCTR) | 15/05/2013 | 22/02/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 1578 | EUCTR2012-003223-38-GB (EUCTR) | 14/05/2013 | 12/02/2013 | Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials. | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 | RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 157 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | ||
| 1579 | EUCTR2012-003439-41-NL (EUCTR) | 14/05/2013 | 27/03/2013 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1580 | EUCTR2012-001984-66-CZ (EUCTR) | 13/05/2013 | 27/03/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand | |||
| 1581 | EUCTR2013-000337-13-DE (EUCTR) | 13/05/2013 | 12/02/2013 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Serbia;Portugal;Germany | ||
| 1582 | EUCTR2012-005026-30-LT (EUCTR) | 10/05/2013 | 21/02/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 1583 | NCT01927757 (ClinicalTrials.gov) | May 6, 2013 | 5/6/2013 | Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab | A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent | Moderate to Severe Rheumatoid Arthritis | Biological: Etanercept;Drug: Methotrexate | Amgen | NULL | Terminated | 18 Years | N/A | All | 90 | Phase 4 | United States;Canada;Puerto Rico |
| 1584 | EUCTR2010-019262-86-SK (EUCTR) | 02/05/2013 | 04/03/2013 | Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2100 | Phase 3 | Portugal;United States;Belarus;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;New Zealand;Sweden | ||
| 1585 | EUCTR2012-003536-23-NL (EUCTR) | 01/05/2013 | 22/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary | |||
| 1586 | NCT01357759 (ClinicalTrials.gov) | May 2013 | 18/5/2011 | Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MORAb-022 | Morphotek | NULL | Completed | 18 Years | 75 Years | Both | 20 | Phase 1 | United States;Netherlands |
| 1587 | NCT01873443 (ClinicalTrials.gov) | May 2013 | 22/5/2013 | Long-Term Efficacy and Safety of CT-P10 in Patients With RA | An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1 | Rheumatoid Arthritis | Drug: Rituximab, MTX, folic acid | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 87 | Phase 1 | Korea, Republic of |
| 1588 | NCT02468791 (ClinicalTrials.gov) | May 2013 | 9/6/2015 | MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | Mabion SA | NULL | Completed | 18 Years | 80 Years | All | 709 | Phase 3 | Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine |
| 1589 | EUCTR2012-001984-66-ES (EUCTR) | 25/04/2013 | 09/04/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | |||
| 1590 | EUCTR2012-001984-66-GB (EUCTR) | 25/04/2013 | 04/03/2013 | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate | A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 5910 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand | ||
| 1591 | EUCTR2010-022243-38-NL (EUCTR) | 23/04/2013 | 13/12/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy - SIRROUND-T | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | |||
| 1592 | EUCTR2012-004090-16-DE (EUCTR) | 23/04/2013 | 06/11/2012 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand | |||
| 1593 | EUCTR2011-003538-16-PL (EUCTR) | 23/04/2013 | 08/03/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | |||
| 1594 | EUCTR2012-002322-73-LT (EUCTR) | 16/04/2013 | 28/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1595 | EUCTR2012-002323-15-GR (EUCTR) | 15/04/2013 | 29/03/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3Study Evaluating the Efficacy and Safety of Baricitinib(LY3009104) in Patients with Moderately to Severely ActiveRheumatoid Arthritis Who Have Had an InadequateResponse to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1596 | EUCTR2011-002894-48-NO (EUCTR) | 11/04/2013 | 06/09/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1597 | EUCTR2012-003439-41-LT (EUCTR) | 11/04/2013 | 31/12/2012 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1598 | EUCTR2012-004342-14-LT (EUCTR) | 11/04/2013 | 29/01/2013 | A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2/3 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1599 | EUCTR2012-005026-30-BG (EUCTR) | 10/04/2013 | 05/03/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 1600 | EUCTR2012-003536-23-NO (EUCTR) | 09/04/2013 | 12/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden | ||
| 1601 | EUCTR2012-003881-42-RO (EUCTR) | 09/04/2013 | 23/07/2014 | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Puerto Rico;Romania;Germany | ||
| 1602 | EUCTR2011-004017-17-GB (EUCTR) | 08/04/2013 | 11/01/2013 | Tocilizumab and Remission in early rheumatoid arthritis | Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RoActemra | The University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1603 | EUCTR2012-003536-23-SE (EUCTR) | 08/04/2013 | 07/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | |||
| 1604 | EUCTR2012-003536-23-BE (EUCTR) | 04/04/2013 | 07/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden | |||
| 1605 | EUCTR2012-003439-41-DK (EUCTR) | 04/04/2013 | 22/03/2013 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1606 | EUCTR2012-003057-29-CZ (EUCTR) | 02/04/2013 | 12/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Hungary;Czech Republic;Slovakia | ||
| 1607 | JPRN-JapicCTI-132121 | 01/4/2013 | Abatacept Post-marketing Clinical Study in Japan | A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Intervention name : Abatacept Dosage And administration of the intervention : 10 mg/kg IV / month Control intervention name : Placebo Dosage And administration of the control intervention : 0 mg/kg IV / month | Bristol-Myers Squibb K.K. | Ono Pharmaceutical Co.,LTD. | 20 | BOTH | 400 | Phase 4 | NULL | |||
| 1608 | JPRN-UMIN000009887 | 2013/04/01 | 01/04/2013 | Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 | Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 - Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 | Rheumatoid Arthritis | When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg. When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg. | Department of Orthopaedic surgery, Tohoku University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 1609 | EUCTR2012-003536-23-ES (EUCTR) | 01/04/2013 | 04/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden | |||
| 1610 | NCT01844895 (ClinicalTrials.gov) | April 2013 | 5/4/2013 | Methotrexate-Inadequate Response Autoinjector Device Sub Study | Substudy-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 120 | Phase 3 | NULL |
| 1611 | NCT01851707 (ClinicalTrials.gov) | April 2013 | 8/5/2013 | A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of Duvelisib With Background Methotrexate in Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: IPI-145;Drug: Placebo | SecuraBio | NULL | Completed | 18 Years | 70 Years | All | 322 | Phase 2 | Bulgaria;Colombia;Germany;Hungary;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Ukraine |
| 1612 | NCT01547091 (ClinicalTrials.gov) | April 2013 | 22/2/2012 | Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis | Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II | Rheumatoid Arthritis | Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDS | Alliancells Bioscience Corporation Limited | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 1/Phase 2 | China |
| 1613 | NCT01830985 (ClinicalTrials.gov) | April 2013 | 10/4/2013 | A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis | A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 65 Years | Both | 39 | Phase 2/Phase 3 | United States;Estonia;Lithuania;South Africa |
| 1614 | EUCTR2011-003538-16-CZ (EUCTR) | 29/03/2013 | 08/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 1615 | EUCTR2012-003536-23-IT (EUCTR) | 29/03/2013 | 05/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden | ||
| 1616 | EUCTR2011-002896-40-PL (EUCTR) | 29/03/2013 | 11/02/2013 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 | RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | ||
| 1617 | EUCTR2012-002324-32-SE (EUCTR) | 27/03/2013 | 20/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1618 | EUCTR2012-002322-73-SI (EUCTR) | 26/03/2013 | 19/03/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1619 | EUCTR2011-003538-16-DE (EUCTR) | 26/03/2013 | 10/12/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Czech Republic;Hungary;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | ||
| 1620 | EUCTR2010-019262-86-CZ (EUCTR) | 26/03/2013 | 30/03/2011 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2025 | Phase 3 | United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1621 | EUCTR2011-002840-29-RO (EUCTR) | 25/03/2013 | 16/06/2016 | A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of | ||
| 1622 | EUCTR2012-002339-27-DE (EUCTR) | 21/03/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1623 | JPRN-UMIN000010286 | 2013/03/21 | 21/03/2013 | Maintenance Trial by Orencia in Rheumatoid Arthritis | Maintenance Trial by Orencia in Rheumatoid Arthritis - MATADOR Study | Rheumatoid Arthritis | Patients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept. | Hokkaido University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 150 | Not selected | Japan |
| 1624 | EUCTR2012-002323-15-GB (EUCTR) | 21/03/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1625 | EUCTR2012-002322-73-DE (EUCTR) | 21/03/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Taiwan;Mexico;South Africa;Israel;Australia;Germany;Russian Federation;United States;Portugal;Greece;Latvia;Netherlands;China;Korea, Republic of;Poland;Slovakia;Slovenia;France;Lithuania;Croatia;Argentina | ||
| 1626 | EUCTR2012-002339-27-GB (EUCTR) | 21/03/2013 | 04/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Romania;Germany;Japan;Korea, Republic of | ||
| 1627 | EUCTR2012-005275-14-NO (EUCTR) | 19/03/2013 | 04/02/2013 | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND | Rheumatoid arthritis (RA) MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte | Diakonhjemmet Hospital AS | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 4 | Norway | ||
| 1628 | EUCTR2011-003538-16-PT (EUCTR) | 14/03/2013 | 13/12/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 1629 | EUCTR2012-003536-23-FI (EUCTR) | 13/03/2013 | 19/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden | |||
| 1630 | EUCTR2012-003536-23-EE (EUCTR) | 13/03/2013 | 12/02/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden | |||
| 1631 | EUCTR2012-003881-42-DE (EUCTR) | 13/03/2013 | 09/01/2013 | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Romania;Germany | ||
| 1632 | EUCTR2012-002324-32-GR (EUCTR) | 12/03/2013 | 26/02/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Sweden;Korea, Republic of | ||
| 1633 | EUCTR2012-003644-71-ES (EUCTR) | 12/03/2013 | 21/12/2012 | Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure | A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 168 | France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia | |||
| 1634 | EUCTR2011-005648-93-SK (EUCTR) | 11/03/2013 | 06/02/2013 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany | ||
| 1635 | EUCTR2012-002339-27-BE (EUCTR) | 11/03/2013 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1636 | EUCTR2012-003629-40-CZ (EUCTR) | 11/03/2013 | 23/11/2012 | An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: CNTO6785 Product Code: CNTO6785 INN or Proposed INN: CNTO6785 | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India | ||
| 1637 | EUCTR2011-005649-10-SK (EUCTR) | 11/03/2013 | 06/02/2013 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1638 | EUCTR2011-003538-16-IT (EUCTR) | 08/03/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab | SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand | |||
| 1639 | EUCTR2012-003536-23-HU (EUCTR) | 07/03/2013 | 16/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden | |||
| 1640 | EUCTR2011-006021-23-PL (EUCTR) | 05/03/2013 | 04/01/2013 | . | A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 2 | Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany | ||
| 1641 | EUCTR2011-006020-20-PL (EUCTR) | 05/03/2013 | 19/11/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria | ||
| 1642 | EUCTR2011-006058-94-DE (EUCTR) | 04/03/2013 | 27/08/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 1643 | EUCTR2011-006018-15-PL (EUCTR) | 01/03/2013 | 16/11/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia | ||
| 1644 | NCT02036931 (ClinicalTrials.gov) | March 2013 | 14/1/2014 | A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System | A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System | Noninflammatory Degenerative Joint Disease;Rheumatoid Arthritis | Device: Metal on Polyethylene articulation;Drug: Ceramic on Polyethylene articulation;Device: Ceramic on Ceramic articulation | Zimmer Biomet | NULL | Active, not recruiting | 18 Years | N/A | All | 315 | United States;France;Germany;Ireland;Netherlands;Spain | |
| 1645 | NCT02843789 (ClinicalTrials.gov) | March 2013 | 19/7/2016 | Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy | Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy | Arthritis, Rheumatoid | Drug: Tocilizumab | Centre Hospitalier Universitaire de Besancon | NULL | Completed | 18 Years | 80 Years | All | 109 | Phase 4 | France |
| 1646 | NCT01558089 (ClinicalTrials.gov) | March 2013 | 15/2/2012 | Good EULAR Response In Patients With Early Rheumatoid Arthritis | Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece | Rheumatoid Arthritis | Drug: etanercept;Drug: methotrexate | Pfizer | NULL | Completed | 18 Years | N/A | All | 76 | N/A | Greece |
| 1647 | NCT01715896 (ClinicalTrials.gov) | March 2013 | 16/10/2012 | A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Golimumab 50 mg;Biological: Mavrilimumab 100 mg | MedImmune LLC | NULL | Completed | 18 Years | 80 Years | All | 215 | Phase 2 | Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey |
| 1648 | EUCTR2012-003223-38-ES (EUCTR) | 27/02/2013 | 04/03/2013 | Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials. | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04 | RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 157 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany | |||
| 1649 | EUCTR2012-004342-14-EE (EUCTR) | 26/02/2013 | 31/01/2013 | A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2/3 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1650 | JPRN-UMIN000010126 | 2013/02/25 | 26/02/2013 | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD | Interstitial lung disease related to rheumatoid arthritis | In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases. | Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 34 | Not applicable | Japan |
| 1651 | EUCTR2012-002324-32-BE (EUCTR) | 25/02/2013 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1652 | EUCTR2012-002322-73-ES (EUCTR) | 20/02/2013 | 06/03/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1653 | EUCTR2012-000609-58-BE (EUCTR) | 20/02/2013 | 14/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany | ||
| 1654 | EUCTR2012-003536-23-CZ (EUCTR) | 20/02/2013 | 03/01/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden | |||
| 1655 | EUCTR2012-000610-11-BE (EUCTR) | 20/02/2013 | 14/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany | ||
| 1656 | EUCTR2012-003724-20-HU (EUCTR) | 19/02/2013 | 20/12/2012 | A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate. | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 | Infinity Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 316 | Phase 2 | Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand | ||
| 1657 | EUCTR2012-004090-16-ES (EUCTR) | 19/02/2013 | 29/11/2012 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 INN or Proposed INN: BI 655064 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand | |||
| 1658 | EUCTR2011-003538-16-AT (EUCTR) | 19/02/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 1659 | EUCTR2012-005370-62-IT (EUCTR) | 18/02/2013 | 11/01/2013 | clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes. | No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study. | rheumatoid arthritis and type 2 diabetes mellitus as comorbidity. MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859 MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: ANAKINRA | OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Italy | ||
| 1660 | EUCTR2011-003538-16-GR (EUCTR) | 18/02/2013 | 14/01/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand | |||
| 1661 | EUCTR2011-005649-10-CZ (EUCTR) | 18/02/2013 | 11/12/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Brazil;Germany | ||
| 1662 | EUCTR2012-002322-73-GB (EUCTR) | 15/02/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1663 | JPRN-UMIN000010033 | 2013/02/14 | 14/02/2013 | To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy | To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy - To investigate the efficacy of tocilizumab in RA patients with moderate disease activity | Rheumatoid Arthritis | Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks. | Daihei Kida | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 20 | Not selected | Japan |
| 1664 | EUCTR2011-003538-16-HU (EUCTR) | 14/02/2013 | 14/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 1665 | EUCTR2012-002339-27-CZ (EUCTR) | 13/02/2013 | 04/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1666 | EUCTR2012-002322-73-SK (EUCTR) | 12/02/2013 | 05/02/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1667 | EUCTR2012-002339-27-SK (EUCTR) | 12/02/2013 | 05/02/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1668 | EUCTR2012-002323-15-DK (EUCTR) | 08/02/2013 | 08/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1669 | EUCTR2011-006344-71-DE (EUCTR) | 08/02/2013 | 25/04/2012 | Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate | Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Trichuris suis ova Product Name: Trichuris suis ova Product Code: TSO INN or Proposed INN: Trichuris suis ova Other descriptive name: Pig whipworm eggs | Immanuel Krankenhaus Berlin | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 1670 | EUCTR2010-022242-24-BG (EUCTR) | 07/02/2013 | 11/12/2012 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of | ||
| 1671 | EUCTR2011-006018-15-HU (EUCTR) | 06/02/2013 | 30/11/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Czech Republic;Hungary;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia | ||
| 1672 | EUCTR2011-002894-48-BG (EUCTR) | 06/02/2013 | 20/11/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1673 | EUCTR2012-002324-32-IT (EUCTR) | 06/02/2013 | 11/01/2013 | A phase 3 study in moderate to severe rheumatoid arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Trade Name: Maxtrex INN or Proposed INN: METHOTREXATE Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Trade Name: Maxtrex INN or Proposed INN: METHOTREXATE | ELI LILLY AND COMPANY | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1674 | EUCTR2012-000439-17-HU (EUCTR) | 05/02/2013 | 20/11/2012 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc. | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of | ||
| 1675 | EUCTR2011-005649-10-HU (EUCTR) | 05/02/2013 | 27/11/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1676 | EUCTR2012-003194-25-LT (EUCTR) | 04/02/2013 | 24/09/2012 | Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB | Mabion S.A. | NULL | Not Recruiting | Female: yes Male: yes | 863 | Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia | |||
| 1677 | EUCTR2011-003538-16-LT (EUCTR) | 04/02/2013 | 05/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | |||
| 1678 | EUCTR2012-002339-27-PT (EUCTR) | 01/02/2013 | 02/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1679 | EUCTR2011-006021-23-CZ (EUCTR) | 01/02/2013 | 06/12/2012 | . | A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 2 | Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany | ||
| 1680 | NCT01724931 (ClinicalTrials.gov) | February 2013 | 7/11/2012 | Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid Arthritis | A Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LD-aminopterin;Drug: placebo | Syntrix Biosystems, Inc. | NULL | Completed | 18 Years | N/A | Both | 175 | Phase 2 | Ukraine |
| 1681 | EUCTR2012-002324-32-GB (EUCTR) | 31/01/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1682 | EUCTR2011-003538-16-SK (EUCTR) | 29/01/2013 | 08/03/2013 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand | |||
| 1683 | EUCTR2012-002323-15-BE (EUCTR) | 28/01/2013 | 20/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1684 | NCT01712399 (ClinicalTrials.gov) | January 28, 2013 | 19/10/2012 | A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Mavrilimumab 100 mg | MedImmune LLC | NULL | Terminated | 19 Years | 79 Years | All | 409 | Phase 2 | Argentina;Bulgaria;Chile;Colombia;Czechia;Estonia;Germany;Greece;Hungary;Israel;Mexico;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 1685 | EUCTR2011-002894-48-DE (EUCTR) | 25/01/2013 | 24/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1686 | EUCTR2012-002323-15-PL (EUCTR) | 25/01/2013 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1687 | EUCTR2011-006021-23-BG (EUCTR) | 25/01/2013 | 13/12/2012 | A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015K | A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 2 | Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia | ||
| 1688 | EUCTR2012-002322-73-GR (EUCTR) | 24/01/2013 | 13/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1689 | EUCTR2012-003439-41-EE (EUCTR) | 24/01/2013 | 02/01/2013 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Estonia;Lithuania;Denmark;South Africa;Netherlands | ||
| 1690 | EUCTR2012-003881-42-BE (EUCTR) | 24/01/2013 | 18/12/2012 | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Puerto Rico;Belgium;Romania;Germany | ||
| 1691 | EUCTR2012-003881-42-SK (EUCTR) | 23/01/2013 | 27/04/2016 | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Slovakia;Puerto Rico;Belgium;Romania;Germany | ||
| 1692 | EUCTR2012-002324-32-DE (EUCTR) | 23/01/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1693 | EUCTR2012-002322-73-CZ (EUCTR) | 22/01/2013 | 04/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1694 | EUCTR2012-002535-28-GB (EUCTR) | 21/01/2013 | 14/12/2012 | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra | Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 1695 | EUCTR2012-002322-73-BE (EUCTR) | 21/01/2013 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1696 | EUCTR2012-002760-27-BG (EUCTR) | 21/01/2013 | 09/11/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 1697 | EUCTR2011-001122-18-BG (EUCTR) | 18/01/2013 | 28/08/2012 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria | ||
| 1698 | EUCTR2012-002322-73-PT (EUCTR) | 18/01/2013 | 02/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1699 | EUCTR2012-002324-32-PT (EUCTR) | 18/01/2013 | 02/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1700 | EUCTR2011-002894-48-ES (EUCTR) | 18/01/2013 | 29/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1701 | EUCTR2012-002323-15-NL (EUCTR) | 17/01/2013 | 17/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 1702 | EUCTR2012-002322-73-NL (EUCTR) | 17/01/2013 | 17/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1703 | EUCTR2011-003538-16-ES (EUCTR) | 16/01/2013 | 29/11/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists - SARIL-RA-TARGET | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand | ||
| 1704 | EUCTR2012-004631-22-BE (EUCTR) | 15/01/2013 | 11/12/2012 | TapERA:Tapering Etanercept in Reumatoid Artritis. | TapERA:Maintaining remission in RA while tapering Etanercept. - TapERA | reumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Enbrel Product Name: Enbrel Product Code: EMEA/H/C000262 | University Hospitals Leuven | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Belgium | ||
| 1705 | NCT01715831 (ClinicalTrials.gov) | January 15, 2013 | 25/10/2012 | A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 | A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment | Arthritis, Rheumatoid | Drug: DMARDs;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 26 | Phase 4 | Brazil |
| 1706 | EUCTR2012-002322-73-HU (EUCTR) | 14/01/2013 | 27/11/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 1707 | EUCTR2012-002181-12-HU (EUCTR) | 14/01/2013 | 28/11/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 Other descriptive name: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden | ||
| 1708 | EUCTR2012-002323-15-AT (EUCTR) | 14/01/2013 | 08/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1709 | EUCTR2012-002324-32-AT (EUCTR) | 14/01/2013 | 09/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 1710 | EUCTR2012-002339-27-HU (EUCTR) | 14/01/2013 | 22/11/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of | ||
| 1711 | EUCTR2012-002322-73-LV (EUCTR) | 11/01/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis. | A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1712 | EUCTR2011-006020-20-BG (EUCTR) | 11/01/2013 | 04/01/2013 | A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria | ||
| 1713 | EUCTR2011-006018-15-BG (EUCTR) | 10/01/2013 | 28/12/2012 | A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who are having insufficient relief from methotrexate | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia | ||
| 1714 | EUCTR2011-002067-20-GR (EUCTR) | 10/01/2013 | 13/12/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1715 | EUCTR2012-000439-17-PL (EUCTR) | 10/01/2013 | 13/11/2012 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457 (free acid) Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457 (free acid) | Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan | ||
| 1716 | EUCTR2012-002181-12-IT (EUCTR) | 10/01/2013 | 06/11/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti- TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;Hungary;Brazil;Australia;Peru;Denmark;South Africa;New Zealand;Sweden | ||
| 1717 | EUCTR2012-002323-15-ES (EUCTR) | 09/01/2013 | 09/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 1718 | EUCTR2012-003644-71-NL (EUCTR) | 07/01/2013 | 07/01/2013 | Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure | A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate. | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands | |||
| 1719 | EUCTR2012-000609-58-IT (EUCTR) | 07/01/2013 | 25/09/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics - NN8226-3612 | Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: 0109-0012A 100 mg/ml Product Name: NA Product Code: 0109-0012A 50 mg/ml Product Name: NA Product Code: 0109-0012A 25 mg/ml | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1720 | ChiCTR-TRC-13002981 | 2013-01-07 | 2013-01-07 | Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy | Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy | rheumatoid arthritis;M06.991 | A:GTT tablets, 10 mg 3 times a day after meals. Yi Shen Juan Bi (YSJB) ,1 pocket (8 g) 3 times a day after meals;B:Methotrexate (MTX)10 mg/week and Sulfasalazine (SSZ),at an initial dose of 0.5 g three times a day in the first week, from the second week the dose was 1.0g twice a day; | Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences | NULL | Completed | 18 | 70 | Both | A:110;B:110; | NULL | |
| 1721 | EUCTR2012-002339-27-IT (EUCTR) | 07/01/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib | ELI LILLY AND COMPANY | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Portugal;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Germany;Japan;Korea, Republic of | ||
| 1722 | NCT02089087 (ClinicalTrials.gov) | January 7, 2013 | 13/3/2014 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: CFZ533;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 75 | Phase 1 | United States;Taiwan |
| 1723 | EUCTR2012-000610-11-IT (EUCTR) | 07/01/2013 | 25/09/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: 0109-0012A 100 mg/ml Product Name: NA Product Code: 0109-0012A 50 mg/ml Product Name: NA Product Code: 0109-0012A 25 mg/ml | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1724 | EUCTR2012-001618-40-PL (EUCTR) | 04/01/2013 | 31/10/2012 | Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate. | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tabalumab Product Code: LY2127399 Other descriptive name: TABALUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Czech Republic;Argentina;Poland;Russian Federation | |||
| 1725 | EUCTR2011-005649-10-PT (EUCTR) | 04/01/2013 | 10/09/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1726 | EUCTR2011-006021-23-HU (EUCTR) | 04/01/2013 | 24/10/2012 | . | A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 2 | Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany | ||
| 1727 | NCT01965132 (ClinicalTrials.gov) | January 1, 2013 | 11/10/2013 | Korean College of Rheumatology Biologics Registry | Korean College of Rheumatology Biologics Registry | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Biologic DMARD | Seoul National University Hospital | NULL | Recruiting | 18 Years | N/A | All | 7000 | Korea, Republic of | |
| 1728 | JPRN-UMIN000007404 | 2013/01/01 | 01/03/2012 | Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. | Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. - Comparison between concomitant therapy of non-biologic anti-rheumatic drugs and therapy with MTX dose escalation aiming for remission on RA patient (CONAMON Study) | Rheumatoid arthritis | Dose escalation of methotrexate Concomitant therapy of methotrexate and bucillamine | KONAMON Study Group | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 90 | Not applicable | Japan |
| 1729 | ChiCTR-TRC-13003948 | 2013-01-01 | 2013-12-05 | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | rheumatoid arthritis | Control:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ; | Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine | NULL | Completed | 18 | 70 | Both | Control:60;EA combined with medicine group:60; | China | |
| 1730 | NCT01389388 (ClinicalTrials.gov) | January 2013 | 16/4/2010 | Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease | Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases | Carotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid Arthritis | Drug: Rosuvastatin | Diakonhjemmet Hospital | NULL | Completed | 35 Years | 80 Years | Both | 114 | N/A | Norway |
| 1731 | NCT01721044 (ClinicalTrials.gov) | January 2013 | 1/11/2012 | A Moderate to Severe Rheumatoid Arthritis Study | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 527 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India |
| 1732 | NCT01754935 (ClinicalTrials.gov) | January 2013 | 18/12/2012 | A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX-509 Using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects With Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: VX-509;Drug: VX-509 matching placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 2 | United States;Denmark;Estonia;Lithuania;Netherlands;South Africa |
| 1733 | NCT01765478 (ClinicalTrials.gov) | January 2013 | 7/1/2013 | Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers | A Phase1 Study, to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered HM71224 in Healthy, Adult Male Volunteers | Rheumatoid Arthritis | Drug: HM71224 single ascending dose;Drug: HM71224 food effect;Drug: HM71224 Multiple ascending dose | Hanmi Pharmaceutical Company Limited | NULL | Completed | 18 Years | 65 Years | Male | 62 | Phase 1 | Netherlands |
| 1734 | NCT01767844 (ClinicalTrials.gov) | January 2013 | 8/1/2013 | Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? | Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial | Rheumatoid Arthritis | Dietary Supplement: Creatine;Dietary Supplement: Placebo | Bangor University | NULL | Active, not recruiting | 18 Years | N/A | Both | 43 | N/A | United Kingdom |
| 1735 | EUCTR2012-002323-15-IT (EUCTR) | 18/12/2012 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON | Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib | ELI LILLY AND COMPANY | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of | ||
| 1736 | EUCTR2011-006018-15-CZ (EUCTR) | 12/12/2012 | 03/08/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia | ||
| 1737 | EUCTR2011-006020-20-CZ (EUCTR) | 12/12/2012 | 03/08/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria | ||
| 1738 | EUCTR2011-006058-94-PT (EUCTR) | 11/12/2012 | 23/10/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 1739 | EUCTR2011-005634-19-PL (EUCTR) | 11/12/2012 | 06/11/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany | ||
| 1740 | EUCTR2010-020992-21-GR (EUCTR) | 11/12/2012 | 06/12/2012 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India | ||
| 1741 | JPRN-UMIN000009425 | 2012/12/06 | 01/12/2012 | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient - Go-Go trial | Rheumatoid Arthritis | The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year. | Osaka City University Medical School | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 4 | Japan |
| 1742 | EUCTR2010-022243-38-BE (EUCTR) | 04/12/2012 | 06/09/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | Portugal;Serbia;United States;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | |||
| 1743 | EUCTR2011-006058-94-GR (EUCTR) | 04/12/2012 | 23/10/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of | ||
| 1744 | EUCTR2011-005376-42-BG (EUCTR) | 03/12/2012 | 28/08/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;Hungary;Spain;Poland;Russian Federation;Bulgaria;Latvia | |||
| 1745 | ChiCTR-DDT-12002658 | 2012-12-01 | 2012-11-04 | Validation of early rheumatoid arthritis classification criteria | Validation of early rheumatoid arthritis classification criteria | rheumatoid arthritis | Gold Standard:;Index test:; | Peking University People's Hospital | NULL | Completed | 16 | 100 | Both | Target condition:0;Difficult condition:0 | China | |
| 1746 | JPRN-UMIN000013885 | 2012/12/01 | 05/05/2014 | Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study | Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study - Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study | rheumatoid arthiritis | RA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples. | Itabashi Chuo Medical Center | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 1747 | NCT01759030 (ClinicalTrials.gov) | December 2012 | 20/12/2012 | Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis | Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies | Rheumatoid Arthritis | Drug: Rituximab | Biocad | NULL | Completed | 18 Years | 80 Years | All | 181 | Phase 3 | Belarus;India;Russian Federation;Ukraine;Colombia |
| 1748 | NCT01772316 (ClinicalTrials.gov) | December 2012 | 17/1/2013 | A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 47 | Phase 3 | Spain |
| 1749 | NCT01752855 (ClinicalTrials.gov) | December 2012 | 17/12/2012 | Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab | Rheumatoid Arthritis | Biological: New formulation adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 88 | Phase 2 | United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia |
| 1750 | NCT01751776 (ClinicalTrials.gov) | December 2012 | 14/12/2012 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy | A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy | Arthritis, Rheumatoid;Healthy | Drug: BI 655064 medium dose;Drug: BI 655064 high dose;Drug: Placebo;Drug: BI 655064 low dose | Boehringer Ingelheim | NULL | Completed | 18 Years | 70 Years | Both | 107 | Phase 1 | Czech Republic;Germany;Netherlands;New Zealand;Poland;Spain;Romania |
| 1751 | NCT01770106 (ClinicalTrials.gov) | December 2012 | 3/1/2013 | RA Denosumab on Bone Microstructure Study | Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Denosumab;Drug: Alendronate | Chinese University of Hong Kong | NULL | Completed | 18 Years | 80 Years | Female | 40 | Phase 4 | Hong Kong |
| 1752 | NCT01721057 (ClinicalTrials.gov) | December 2012 | 1/11/2012 | A Study in Moderate to Severe Rheumatoid Arthritis Participants | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 684 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic |
| 1753 | EUCTR2012-002181-12-ES (EUCTR) | 27/11/2012 | 23/08/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-alpha Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden | ||
| 1754 | EUCTR2010-022243-38-GB (EUCTR) | 21/11/2012 | 29/06/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | ||
| 1755 | EUCTR2011-006021-23-BE (EUCTR) | 19/11/2012 | 25/10/2012 | . | A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study | Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 2 | Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany | ||
| 1756 | JPRN-UMIN000011181 | 2012/11/19 | 12/07/2013 | Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial | Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial - Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial | Osteoarthritis of knee, rheumatoid arthritis | A continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral total knee arthroplasty | Nekoyama miyao hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 1757 | EUCTR2012-002181-12-GR (EUCTR) | 16/11/2012 | 08/10/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden | ||
| 1758 | EUCTR2011-002894-48-GR (EUCTR) | 16/11/2012 | 19/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1759 | EUCTR2011-001122-18-CZ (EUCTR) | 15/11/2012 | 10/07/2012 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Korea, Democratic People's Republic of;Turkey;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Argentina;Singapore;Peru;Bulgaria | ||
| 1760 | EUCTR2010-022243-38-IT (EUCTR) | 14/11/2012 | 11/12/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | JANSSEN-CILAG INTERNATIONAL N.V. | NULL | Not Recruiting | Female: yes Male: yes | 990 | Portugal;United States;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;Canada;Argentina;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 1761 | EUCTR2012-002760-27-ES (EUCTR) | 14/11/2012 | 23/01/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 1762 | EUCTR2012-003057-29-HU (EUCTR) | 13/11/2012 | 19/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Czech Republic;Hungary;Slovakia | ||
| 1763 | EUCTR2012-003057-29-SK (EUCTR) | 12/11/2012 | 19/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Hungary;Czech Republic;Slovakia | ||
| 1764 | EUCTR2012-002181-12-GB (EUCTR) | 12/11/2012 | 21/08/2012 | A Phase IIa Proof Of Concept study to evaluate Safety, Tolerability and Efficacy in Subjects with Rheumatoid Arthritis | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden | ||
| 1765 | EUCTR2012-002760-27-SK (EUCTR) | 12/11/2012 | 11/10/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 1766 | EUCTR2011-005648-93-BG (EUCTR) | 09/11/2012 | 16/08/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany | ||
| 1767 | EUCTR2010-019262-86-PT (EUCTR) | 09/11/2012 | 09/08/2012 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | Poland;Belgium;Brazil;Belarus;Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Ecuador;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1768 | EUCTR2011-002894-48-PT (EUCTR) | 09/11/2012 | 09/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1769 | EUCTR2012-002760-27-IT (EUCTR) | 08/11/2012 | 30/10/2012 | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis. | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 1770 | EUCTR2012-002760-27-DE (EUCTR) | 06/11/2012 | 25/09/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | Romania;Bulgaria;Germany;United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil | |||
| 1771 | EUCTR2012-001618-40-CZ (EUCTR) | 05/11/2012 | 03/08/2012 | Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate. | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tabalumab Product Code: LY2127399 Other descriptive name: TABALUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Czech Republic;Argentina;Poland;Russian Federation | |||
| 1772 | EUCTR2012-001760-30-IT (EUCTR) | 05/11/2012 | 25/07/2012 | Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent. | Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB | OSSERVATORIO EPIDEMIOLOGICO GISEA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1773 | JPRN-UMIN000009088 | 2012/11/01 | 12/10/2012 | Bio Logic MateTM clinical performance test for IFX Efficacy prediction | Bio Logic MateTM clinical performance test for IFX Efficacy prediction - Bio Logic MateTM clinical performance test for IFX Efficacy prediction | rheumatoid arthritis | IFX plus methotrexate | Bio Logic Mate Study Group | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 150 | Not selected | Japan |
| 1774 | EUCTR2012-000609-58-GB (EUCTR) | 01/11/2012 | 20/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1775 | NCT01725230 (ClinicalTrials.gov) | November 2012 | 7/11/2012 | Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib | An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 42 | Phase 1 | United States |
| 1776 | NCT01749787 (ClinicalTrials.gov) | November 2012 | 6/12/2012 | Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis | A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcg | Protalex, Inc. | NULL | Completed | 18 Years | N/A | Both | 61 | Phase 1 | United States |
| 1777 | NCT01741493 (ClinicalTrials.gov) | November 2012 | 3/12/2012 | A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494 | A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494 | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo;Drug: Tofacitinib | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 67 | Phase 1 | United States |
| 1778 | NCT01711359 (ClinicalTrials.gov) | November 2012 | 18/10/2012 | A Study in Participants With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic Acid | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 588 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom |
| 1779 | NCT01709760 (ClinicalTrials.gov) | November 2012 | 16/10/2012 | A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: ENIA11;Drug: Placebo | Mycenax Biotech Inc. | NULL | Unknown status | 20 Years | N/A | All | 91 | Phase 3 | Taiwan |
| 1780 | EUCTR2011-002840-29-CZ (EUCTR) | 31/10/2012 | 05/09/2012 | A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of | ||
| 1781 | NCT01679951 (ClinicalTrials.gov) | October 31, 2012 | 3/9/2012 | A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Dose Range Finding Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: JNJ-38518168 (3 mg);Drug: JNJ-38518168 (10 mg);Drug: JNJ-38518168 (30 mg);Drug: Methotrexate | Janssen Research & Development, LLC | NULL | Terminated | 18 Years | 80 Years | All | 272 | Phase 2 | United States;Argentina;Chile;Colombia;Czechia;Hungary;Japan;Korea, Republic of;Latvia;Mexico;Poland;Romania;Russian Federation;Taiwan;Thailand;Ukraine;Czech Republic |
| 1782 | NCT01636843 (ClinicalTrials.gov) | October 30, 2012 | 6/7/2012 | A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: placebo | Novo Nordisk A/S | NULL | Terminated | 18 Years | 75 Years | All | 298 | Phase 2 | United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic |
| 1783 | NCT01741688 (ClinicalTrials.gov) | October 26, 2012 | 30/11/2012 | An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis | A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 16 | N/A | Peru |
| 1784 | EUCTR2011-002840-29-HU (EUCTR) | 25/10/2012 | 04/09/2012 | A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of | ||
| 1785 | EUCTR2011-005634-19-BG (EUCTR) | 24/10/2012 | 19/10/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany | ||
| 1786 | EUCTR2010-021146-22-GB (EUCTR) | 23/10/2012 | 25/10/2012 | Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system | Alemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome) Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994) | The Newcastle upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | United Kingdom | ||
| 1787 | EUCTR2011-002896-40-DE (EUCTR) | 23/10/2012 | 02/07/2012 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01 | RHEUMATOID ARTHRITIS MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US | NULL | Not Recruiting | Female: yes Male: yes | 195 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany | |||
| 1788 | EUCTR2011-002840-29-LV (EUCTR) | 22/10/2012 | 25/10/2012 | A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of | ||
| 1789 | EUCTR2010-022243-38-ES (EUCTR) | 22/10/2012 | 21/08/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 990 | United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of | |||
| 1790 | EUCTR2011-005649-10-ES (EUCTR) | 22/10/2012 | 19/07/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 1791 | EUCTR2012-000535-36-PL (EUCTR) | 18/10/2012 | 13/09/2012 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany | |||
| 1792 | EUCTR2012-000610-11-ES (EUCTR) | 17/10/2012 | 09/07/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1793 | EUCTR2011-002894-48-HU (EUCTR) | 16/10/2012 | 16/08/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1794 | EUCTR2010-022243-38-PT (EUCTR) | 15/10/2012 | 27/08/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | |||
| 1795 | EUCTR2012-002573-62-SE (EUCTR) | 12/10/2012 | 14/08/2012 | Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab | Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab | Rheumatoid arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Humira | The Karolinska Institute, ClinTRID | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Sweden | ||
| 1796 | NCT01736189 (ClinicalTrials.gov) | October 11, 2012 | 27/11/2012 | Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice | Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX) | Rheumatoid Arthritis | Drug: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 16 Years | 99 Years | All | 346 | Japan | |
| 1797 | NCT01636557 (ClinicalTrials.gov) | October 11, 2012 | 6/7/2012 | A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis | A Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: Caffeine | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 65 Years | All | 12 | Phase 1 | Germany;Korea, Republic of;Moldova, Republic of;South Africa |
| 1798 | EUCTR2007-002066-35-SK (EUCTR) | 10/10/2012 | 15/04/2008 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy | ||
| 1799 | EUCTR2011-005648-93-HU (EUCTR) | 09/10/2012 | 17/04/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany | |||
| 1800 | EUCTR2012-002760-27-HU (EUCTR) | 09/10/2012 | 03/09/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 1801 | EUCTR2011-002894-48-EE (EUCTR) | 08/10/2012 | 08/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1802 | EUCTR2011-005648-93-GR (EUCTR) | 03/10/2012 | 05/10/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany | ||
| 1803 | EUCTR2011-005649-10-GR (EUCTR) | 03/10/2012 | 05/10/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Czech Republic;Mexico;Argentina;Brazil;Germany;Hungary;Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France | ||
| 1804 | JPRN-UMIN000018101 | 2012/10/01 | 26/06/2015 | Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study | Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study - Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study | Osteoarthritis, rheumatoid arthritis, osteonecrosis | To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7. Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14. | Yokohama City University School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan |
| 1805 | JPRN-JapicCTI-132091 | 01/10/2012 | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : subcutaneously 75mg, 150mg Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | 234 | Phase 3 | NULL | |||
| 1806 | JPRN-UMIN000008812 | 2012/10/01 | 01/10/2012 | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity | NULL | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 1807 | NCT01730456 (ClinicalTrials.gov) | October 2012 | 15/11/2012 | A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926 | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 13 | Phase 3 | Macedonia, The Former Yugoslav Republic of |
| 1808 | NCT02915094 (ClinicalTrials.gov) | October 2012 | 23/9/2016 | Kineret in the Treatment of Rheumatoid Arthritis | Kineret in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Anakinra | Swedish Orphan Biovitrum | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Germany |
| 1809 | NCT01710358 (ClinicalTrials.gov) | October 2012 | 17/10/2012 | A Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 1307 | Phase 3 | United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands |
| 1810 | NCT01770379 (ClinicalTrials.gov) | October 2012 | 16/10/2012 | Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents. | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents | Rheumatoid Arthritis | Biological: Secukinumab (AIN457);Biological: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 242 | Phase 3 | United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico |
| 1811 | NCT01734993 (ClinicalTrials.gov) | October 2012 | 19/11/2012 | A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA). | A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 11 | Phase 3 | France |
| 1812 | EUCTR2011-004419-22-BG (EUCTR) | 29/09/2012 | 22/06/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1813 | JPRN-jRCTs032180245 | 28/09/2012 | 12/03/2019 | Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study | Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study | Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis | Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE) | Kume Shinichiro | NULL | Not Recruiting | >= 20age old | <= 75age old | Both | 352 | Phase 4 | Japan |
| 1814 | EUCTR2012-002760-27-CZ (EUCTR) | 27/09/2012 | 13/08/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 1815 | EUCTR2011-006058-94-CZ (EUCTR) | 26/09/2012 | 19/07/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 1816 | EUCTR2012-000609-58-DE (EUCTR) | 25/09/2012 | 27/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1817 | EUCTR2012-000610-11-DE (EUCTR) | 25/09/2012 | 03/07/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1818 | EUCTR2012-002181-12-DK (EUCTR) | 24/09/2012 | 24/09/2012 | A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - RADIUS-010 | Active rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Denmark;Peru;Australia;South Africa;New Zealand;Sweden | ||
| 1819 | JPRN-UMIN000015297 | 2012/09/19 | 01/10/2014 | The feasibility study of accelated infliximab infusion from initial administration | The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | NULL | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan |
| 1820 | EUCTR2011-005634-19-DE (EUCTR) | 19/09/2012 | 02/05/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1821 | EUCTR2011-005648-93-DE (EUCTR) | 19/09/2012 | 11/05/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany | ||
| 1822 | EUCTR2011-002894-48-GB (EUCTR) | 14/09/2012 | 06/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1823 | JPRN-JapicCTI-152782 | 12/9/2012 | 29/01/2015 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : Kolbet INN of the intervention : Iguratimod Dosage And administration of the intervention : Oral | Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.) | NULL | BOTH | 2000 | NA | NULL | |||
| 1824 | JPRN-JapicCTI-132051 | 12/9/2012 | 23/01/2013 | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis | Rheumatoid Arthritis | Intervention name : iguratimod (Careram) Dosage And administration of the intervention : Oral | Eisai Co., Ltd. | NULL | BOTH | 2000 | NA | NULL | |||
| 1825 | NCT01850966 (ClinicalTrials.gov) | September 12, 2012 | 8/5/2013 | Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis | Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod | Eisai Co., Ltd. | NULL | Completed | N/A | N/A | All | 2747 | Japan | |
| 1826 | EUCTR2011-005648-93-ES (EUCTR) | 10/09/2012 | 24/05/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany | ||
| 1827 | EUCTR2011-002894-48-NL (EUCTR) | 10/09/2012 | 14/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1828 | EUCTR2011-006020-20-HU (EUCTR) | 07/09/2012 | 29/06/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Rheumatoid Arthritis MedDRA version: 15.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Czech Republic;Hungary;Mexico;Poland;Ukraine;Bulgaria | ||
| 1829 | EUCTR2010-022243-38-DE (EUCTR) | 05/09/2012 | 21/06/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | |||
| 1830 | EUCTR2012-000535-36-DE (EUCTR) | 05/09/2012 | 15/06/2012 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany | |||
| 1831 | NCT01682512 (ClinicalTrials.gov) | September 5, 2012 | 10/8/2012 | Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis | Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial. | Arthritis, Rheumatoid | Drug: BI 695500;Drug: Rituxan®;Drug: MabThera® | Boehringer Ingelheim | NULL | Terminated | 18 Years | 80 Years | All | 294 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden |
| 1832 | EUCTR2011-006058-94-IT (EUCTR) | 04/09/2012 | 13/09/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of | ||
| 1833 | EUCTR2010-022243-38-AT (EUCTR) | 04/09/2012 | 01/08/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | |||
| 1834 | NCT01635686 (ClinicalTrials.gov) | September 2012 | 4/7/2012 | Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers | A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers | Rheumatoid Arthritis | Drug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ. | Daewoong Pharmaceutical Co. LTD. | NULL | Not yet recruiting | 20 Years | 45 Years | Male | 38 | Phase 1 | Korea, Republic of |
| 1835 | NCT01647451 (ClinicalTrials.gov) | September 2012 | 19/7/2012 | A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis | A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 62 | Phase 2 | Bulgaria;Hungary;Latvia;Poland;Russian Federation;Serbia;Spain |
| 1836 | NCT01640938 (ClinicalTrials.gov) | September 2012 | 12/7/2012 | Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis | A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Secukinumab (AIN457) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 259 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania |
| 1837 | NCT01676701 (ClinicalTrials.gov) | September 2012 | 29/8/2012 | Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA) | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled Syringe | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 3 | United States;Argentina;Czechia;Poland;Puerto Rico;Russian Federation;Czech Republic |
| 1838 | NCT01661140 (ClinicalTrials.gov) | September 2012 | 7/8/2012 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage | Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX | Rheumatoid Arthritis | Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose) | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 427 | Phase 4 | United Kingdom |
| 1839 | EUCTR2012-000535-36-BE (EUCTR) | 28/08/2012 | 05/06/2012 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany | ||
| 1840 | EUCTR2011-006070-73-DE (EUCTR) | 28/08/2012 | 24/02/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany | |||
| 1841 | EUCTR2011-002067-20-IT (EUCTR) | 23/08/2012 | 13/09/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira INN or Proposed INN: ADALIMUMAB | UCB PHARMA SA/NV. | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1842 | EUCTR2012-000535-36-SK (EUCTR) | 23/08/2012 | 14/06/2012 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany | |||
| 1843 | NCT01643928 (ClinicalTrials.gov) | August 16, 2012 | 6/7/2012 | Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04) | EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS | Rheumatoid Arthritis | Biological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses | Pfizer | NULL | Completed | 18 Years | N/A | All | 185 | N/A | United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine |
| 1844 | EUCTR2012-000439-17-DE (EUCTR) | 15/08/2012 | 10/04/2012 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: NA Other descriptive name: MK-8457 Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: NA Other descriptive name: MK-8457 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 434 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan | ||
| 1845 | EUCTR2011-002896-40-GB (EUCTR) | 14/08/2012 | 11/06/2012 | A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 195 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany | ||
| 1846 | NCT04704492 (ClinicalTrials.gov) | August 14, 2012 | 6/1/2021 | A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis | An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Biological: SM03 | SinoMab Pty Ltd | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 1 | China |
| 1847 | EUCTR2012-000610-11-HU (EUCTR) | 13/08/2012 | 18/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1848 | EUCTR2012-000609-58-HU (EUCTR) | 13/08/2012 | 18/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 1849 | EUCTR2011-002894-48-BE (EUCTR) | 02/08/2012 | 18/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 1;Phase 3 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1850 | EUCTR2012-000535-36-CZ (EUCTR) | 02/08/2012 | 18/06/2012 | A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety. | Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany | |||
| 1851 | EUCTR2011-005648-93-CZ (EUCTR) | 01/08/2012 | 24/04/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany | |||
| 1852 | EUCTR2011-005634-19-CZ (EUCTR) | 01/08/2012 | 24/04/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1853 | NCT01645280 (ClinicalTrials.gov) | August 2012 | 6/6/2012 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Placebo + methotrexate (MTX) (Group 1);Drug: Ustekinumab + MTX (Group 2);Drug: Ustekinumab + MTX (Group 3);Drug: CNTO 1959 + MTX (Group 4);Drug: CNTO 1959 + MTX (Group 5) | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 80 Years | All | 274 | Phase 2 | United States;Argentina;Bulgaria;Chile;Colombia;Czech Republic;Hungary;Poland;Russian Federation;Singapore;Ukraine;Korea, Republic of;Mexico;Peru;Turkey |
| 1854 | NCT01870908 (ClinicalTrials.gov) | August 2012 | 4/6/2013 | Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients | Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings | Rheumatoid Arthritis | Drug: tacrolimus;Drug: biological agents | Astellas Pharma Inc | NULL | Completed | N/A | N/A | Both | 664 | N/A | Japan |
| 1855 | NCT01651936 (ClinicalTrials.gov) | August 2012 | 25/7/2012 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010) | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects With Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy | Rheumatoid Arthritis | Drug: MK-8457 100 mg;Drug: Methotrexate;Drug: Dose-match placebo | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 56 | Phase 2 | Australia;Colombia;Denmark;France;Greece;Hungary;Italy;Korea, Republic of;New Zealand;Poland;South Africa;Spain;United Kingdom;United States |
| 1856 | NCT01636817 (ClinicalTrials.gov) | August 2012 | 6/7/2012 | A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: placebo | Novo Nordisk A/S | NULL | Terminated | 18 Years | 75 Years | All | 239 | Phase 2 | United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic |
| 1857 | NCT01652937 (ClinicalTrials.gov) | August 2012 | 19/7/2012 | BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: BIIB057;Drug: Placebo | Biogen Idec | NULL | Withdrawn | 18 Years | N/A | Female | 0 | Phase 2 | Canada |
| 1858 | NCT01662063 (ClinicalTrials.gov) | August 2012 | 30/7/2012 | A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA) | A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Genentech, Inc. | NULL | Completed | 18 Years | N/A | All | 218 | Phase 3 | United States;Puerto Rico |
| 1859 | NCT01746680 (ClinicalTrials.gov) | August 2012 | 4/12/2012 | Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis | Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tacrolimus with Methotrexate | Chong Kun Dang Pharmaceutical | NULL | Completed | 20 Years | N/A | Both | 111 | Phase 4 | Korea, Republic of |
| 1860 | NCT01705730 (ClinicalTrials.gov) | July 31, 2012 | 10/10/2012 | A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy | Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy | Rheumatoid Arthritis | Drug: tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 71 | Belgium | |
| 1861 | EUCTR2011-006018-15-BE (EUCTR) | 28/07/2012 | 02/07/2012 | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide | Astellas Pharma Global Development, Inc. (APGD) | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Poland;Belgium;Ukraine;Bulgaria;Colombia | ||
| 1862 | EUCTR2011-005634-19-ES (EUCTR) | 27/07/2012 | 24/04/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1863 | EUCTR2011-004529-28-CZ (EUCTR) | 25/07/2012 | 03/04/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of | ||
| 1864 | EUCTR2011-002067-20-GB (EUCTR) | 23/07/2012 | 13/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1865 | EUCTR2011-005648-93-EE (EUCTR) | 19/07/2012 | 16/04/2012 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany | |||
| 1866 | EUCTR2012-000439-17-GB (EUCTR) | 17/07/2012 | 16/04/2012 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 | Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck) | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan | ||
| 1867 | EUCTR2010-019262-86-AT (EUCTR) | 12/07/2012 | 06/06/2012 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - SARIL-RA-EXTEND | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Other descriptive name: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden | ||
| 1868 | EUCTR2010-022243-38-LT (EUCTR) | 11/07/2012 | 29/05/2012 | A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 840 | United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand | |||
| 1869 | JPRN-UMIN000010902 | 2012/07/11 | 07/06/2013 | A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty | A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty - A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty | Osteoarthritis of knee, rheumatoid arthritis, avascular necrosis | An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty | Nekoyama miyao hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 1870 | EUCTR2010-022242-24-LT (EUCTR) | 11/07/2012 | 29/05/2012 | A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of | ||
| 1871 | NCT01554696 (ClinicalTrials.gov) | July 6, 2012 | 13/3/2012 | A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate | A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo;Drug: methotrexate | Astellas Pharma Inc | NULL | Completed | 18 Years | N/A | All | 379 | Phase 2 | United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic |
| 1872 | EUCTR2011-005376-42-LV (EUCTR) | 06/07/2012 | 13/03/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0114-0006B | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia | |||
| 1873 | EUCTR2011-002067-20-PT (EUCTR) | 06/07/2012 | 21/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1874 | JPRN-UMIN000008404 | 2012/07/01 | 12/07/2012 | Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. | Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. - Extension of Tocilizumab Dose Intervals in Patients with Rheumatoid Arthritis using IL-6 Serum Level Criteria. | rheumatoid arthritis | Extension of Tocilizumab Dose Intervals | Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 1875 | JPRN-UMIN000033222 | 2012/07/01 | 02/07/2018 | Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases | Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases - Prophylactic Iodine-supported Primary TKA | Osteoarthritis, Rheumatoid arthritis of knee joint | prophylactic iodine-suported primaru TKA | Fukui General Hospital | NULL | Complete: follow-up complete | 50years-old | 90years-old | Male and Female | 30 | Not selected | Japan |
| 1876 | NCT01665430 (ClinicalTrials.gov) | July 2012 | 13/8/2012 | A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-Label, Single Arm, Long-Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 38 | Phase 3 | Poland |
| 1877 | NCT01793259 (ClinicalTrials.gov) | July 2012 | 14/2/2013 | Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA) | An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe | medac GmbH | NULL | Completed | 18 Years | 75 Years | Both | 120 | Phase 3 | Germany |
| 1878 | NCT01597739 (ClinicalTrials.gov) | July 2012 | 10/5/2012 | A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy | Arthritis, Rheumatoid | Drug: JNJ-40346527;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 80 Years | Both | 96 | Phase 2 | Argentina;Bulgaria;Chile;Czech Republic;Hungary;Korea, Republic of;Poland;Russian Federation;Singapore;Ukraine |
| 1879 | NCT01659242 (ClinicalTrials.gov) | July 2012 | 3/8/2012 | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging Study | Rheumatoid Arthritis | Drug: Methotrexate plus sulfasalazine;Drug: Leflunomide | Singapore General Hospital | NULL | Terminated | 21 Years | 65 Years | Both | 1 | Phase 4 | Singapore |
| 1880 | NCT01649804 (ClinicalTrials.gov) | July 2012 | 23/7/2012 | A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG-TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 12 | Phase 3 | Hungary |
| 1881 | NCT01640054 (ClinicalTrials.gov) | July 2012 | 2/7/2012 | A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia | Rheumatoid Arthritis | Drug: Fostamatinib | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam |
| 1882 | NCT01893151 (ClinicalTrials.gov) | July 2012 | 2/7/2013 | Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI | A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI) | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Iguratimod placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | Both | 200 | Phase 4 | China |
| 1883 | NCT01578850 (ClinicalTrials.gov) | July 2012 | 12/4/2012 | Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening | A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s) | Rheumatoid Arthritis | Drug: Etanercept;Drug: placebo | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 491 | Phase 4 | Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia |
| 1884 | EUCTR2010-018485-24-HU (EUCTR) | 29/06/2012 | 02/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Czech Republic;Hungary;Spain;Latvia;Germany | |||
| 1885 | EUCTR2011-002067-20-BG (EUCTR) | 28/06/2012 | 11/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1886 | EUCTR2011-005260-20-GB (EUCTR) | 28/06/2012 | 10/05/2012 | RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor. | Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER | Adult Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium | Roche Products Limited | NULL | Not Recruiting | Female: yes Male: yes | 618 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1887 | EUCTR2011-002067-20-ES (EUCTR) | 26/06/2012 | 10/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1888 | EUCTR2011-002067-20-AT (EUCTR) | 26/06/2012 | 27/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1889 | EUCTR2011-005204-15-AT (EUCTR) | 20/06/2012 | 15/05/2012 | Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped? | Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop | biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT | Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | Austria | ||
| 1890 | EUCTR2011-002067-20-CZ (EUCTR) | 19/06/2012 | 25/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1891 | NCT01565655 (ClinicalTrials.gov) | June 19, 2012 | 27/3/2012 | A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo | Astellas Pharma Global Development, Inc. | NULL | Completed | 18 Years | N/A | All | 289 | Phase 2 | United States;Bulgaria;Czechia;Hungary;Mexico;Poland;Czech Republic |
| 1892 | EUCTR2011-005376-42-ES (EUCTR) | 18/06/2012 | 29/03/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0114-0006B | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Hungary;Poland;Spain;Russian Federation;Bulgaria;Latvia | ||
| 1893 | EUCTR2010-018485-24-LV (EUCTR) | 15/06/2012 | 14/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | Hungary;Czech Republic;Spain;Germany;Latvia | ||
| 1894 | EUCTR2011-001122-18-HU (EUCTR) | 13/06/2012 | 02/05/2012 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria | ||
| 1895 | NCT01638013 (ClinicalTrials.gov) | June 13, 2012 | 9/7/2012 | A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K | Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K | Arthritis, Rheumatoid | Drug: Peficitinib | Astellas Pharma Inc | NULL | Completed | 20 Years | N/A | All | 843 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 1896 | EUCTR2011-005634-19-EE (EUCTR) | 13/06/2012 | 16/04/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany | ||
| 1897 | EUCTR2011-002067-20-DE (EUCTR) | 13/06/2012 | 16/02/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Ireland;Austria;Italy;United States;Portugal;Greece;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1898 | EUCTR2011-001729-25-NL (EUCTR) | 11/06/2012 | 05/03/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1899 | EUCTR2011-005448-87-CZ (EUCTR) | 11/06/2012 | 12/04/2012 | A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S) | A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 320 | United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China | |||
| 1900 | EUCTR2009-017998-37-BE (EUCTR) | 08/06/2012 | 11/04/2012 | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease. MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL | Ghent University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium | ||
| 1901 | EUCTR2011-005021-48-NL (EUCTR) | 07/06/2012 | 05/06/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 1902 | EUCTR2011-004419-22-SK (EUCTR) | 06/06/2012 | 12/04/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1903 | EUCTR2011-004419-22-HU (EUCTR) | 06/06/2012 | 21/03/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1904 | EUCTR2011-004419-22-CZ (EUCTR) | 06/06/2012 | 13/03/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1905 | NCT01611688 (ClinicalTrials.gov) | June 4, 2012 | 1/6/2012 | First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0215-0384;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 1 | Germany |
| 1906 | EUCTR2011-002067-20-IE (EUCTR) | 01/06/2012 | 10/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 1907 | JPRN-UMIN000008281 | 2012/06/01 | 28/06/2012 | Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab | Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab - Study of dose-escalation therapy in IFX-treated RA | rheumatoid arthritis | Dose-escalation of MTX or IFX | Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 1908 | JPRN-UMIN000007806 | 2012/06/01 | 01/05/2012 | The feasibility study of accelated infliximab infusion during maintenance phase | The feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan |
| 1909 | EUCTR2011-001729-25-GB (EUCTR) | 01/06/2012 | 19/04/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 1910 | EUCTR2011-004529-28-BG (EUCTR) | 01/06/2012 | 07/05/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Bulgaria | ||
| 1911 | NCT01602302 (ClinicalTrials.gov) | June 2012 | 16/5/2012 | Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept) | Medical University of Graz | NULL | Terminated | 18 Years | 90 Years | All | 40 | Phase 4 | Austria |
| 1912 | NCT01664104 (ClinicalTrials.gov) | June 2012 | 7/8/2012 | A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting | CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 151 | N/A | Italy |
| 1913 | NCT02015520 (ClinicalTrials.gov) | June 2012 | 6/12/2013 | Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis | A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors | Rheumatoid Arthritis | Drug: Clazakizumab;Drug: Placebo (Matching with Clazakizumab) | CSL Behring | NULL | Completed | 18 Years | N/A | All | 143 | Phase 2 | United States;Argentina;Canada;France;Hungary;Italy;Japan;Mexico;South Africa;Australia |
| 1914 | NCT02052375 (ClinicalTrials.gov) | June 2012 | 30/1/2014 | A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis;Pharmacokinetics of ASP2408 | Drug: ASP2408;Drug: Placebo | Astellas Pharma Global Development, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 24 | Phase 1 | United States |
| 1915 | NCT01712178 (ClinicalTrials.gov) | June 2012 | 14/6/2012 | A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety | Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Adalimumab, current formulation;Biological: Adalimumab, new formulation | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia |
| 1916 | EUCTR2012-000222-21-DE (EUCTR) | 31/05/2012 | 16/03/2012 | Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection. | An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Code: 70930.00.00 INN or Proposed INN: Methotrexate disodium Product Name: methotrexate pre-filled pen INN or Proposed INN: Methotrexate disodium | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1917 | NCT01559103 (ClinicalTrials.gov) | May 31, 2012 | 19/3/2012 | Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients | A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6) | Rheumatoid Arthritis | Biological: MEDI5117;Biological: MEDI5117 Placebo | Novo Nordisk A/S | NULL | Terminated | 20 Years | 75 Years | All | 39 | Phase 1 | United States;Germany;United Kingdom |
| 1918 | EUCTR2011-002067-20-HU (EUCTR) | 30/05/2012 | 20/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 1919 | EUCTR2011-005634-19-HU (EUCTR) | 30/05/2012 | 11/04/2012 | A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany | ||
| 1920 | EUCTR2011-005376-42-HU (EUCTR) | 30/05/2012 | 11/04/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: 0114-0006B | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia | |||
| 1921 | EUCTR2011-004720-35-SE (EUCTR) | 28/05/2012 | 22/12/2011 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Sweden | |||
| 1922 | EUCTR2011-006040-79-DK (EUCTR) | 25/05/2012 | 25/05/2012 | A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth | The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early | Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® | Aarhus University Hospital, Department of Rheumatology U | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Denmark | ||
| 1923 | EUCTR2011-001729-25-IT (EUCTR) | 23/05/2012 | 19/03/2012 | Study designed to demonstrate the efficacy and safety of certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan INN or Proposed INN: METHOTREXATE | UCB PHARMA SA/NV. | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1924 | EUCTR2011-005021-48-CZ (EUCTR) | 23/05/2012 | 15/02/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands | |||
| 1925 | EUCTR2011-004419-22-DE (EUCTR) | 23/05/2012 | 01/03/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1926 | NCT01569152 (ClinicalTrials.gov) | May 22, 2012 | 30/3/2012 | Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008) | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: Methotrexate | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 82 | Phase 2 | Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States |
| 1927 | EUCTR2011-006070-73-BG (EUCTR) | 22/05/2012 | 07/05/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany | |||
| 1928 | EUCTR2011-001729-25-SE (EUCTR) | 22/05/2012 | 22/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 1929 | EUCTR2011-006070-73-CZ (EUCTR) | 16/05/2012 | 29/02/2012 | Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany | |||
| 1930 | EUCTR2011-004529-28-PL (EUCTR) | 14/05/2012 | 28/03/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Bulgaria | ||
| 1931 | EUCTR2011-005021-48-ES (EUCTR) | 14/05/2012 | 21/02/2012 | A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO | Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 1932 | EUCTR2012-000139-21-AT (EUCTR) | 14/05/2012 | 23/04/2012 | Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB | Medizinische Universität Wien, Universitätsklinik für Innere Medizin III | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Czech Republic;Slovakia;Austria;Russian Federation;Switzerland | |||
| 1933 | EUCTR2011-005448-87-HU (EUCTR) | 14/05/2012 | 21/03/2012 | A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S) | A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 320 | United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China | |||
| 1934 | EUCTR2012-000439-17-LT (EUCTR) | 11/05/2012 | 15/03/2012 | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis | active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457 Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457 | MERCK SHARP & DOHME CORP. | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of | ||
| 1935 | EUCTR2011-005008-14-HU (EUCTR) | 10/05/2012 | 28/02/2012 | Not applicable | Randomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 Product Name: GLPG0634 Product Name: GLPG0634 Product Name: GLPG0634 | Galapagos SASU | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;European Union;Ukraine;Russian Federation;Moldova, Republic of | ||
| 1936 | EUCTR2011-005021-48-BG (EUCTR) | 09/05/2012 | 20/04/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands | |||
| 1937 | EUCTR2011-006125-14-HU (EUCTR) | 04/05/2012 | 08/03/2012 | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE | A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: RoActemra Product Code: RO4877533 | Roche (Magyarország) Kft. | NULL | Not Recruiting | Female: yes Male: yes | 241 | Hungary | |||
| 1938 | EUCTR2011-005021-48-HU (EUCTR) | 04/05/2012 | 15/02/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland | |||
| 1939 | EUCTR2011-004419-22-EE (EUCTR) | 02/05/2012 | 21/03/2012 | Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: VX-509 Product Code: VX-509 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany | ||
| 1940 | JPRN-UMIN000014484 | 2012/05/01 | 01/12/2014 | Saitama Actemra study for QOL in patients with Rheumatoid arthritis | Saitama Actemra study for QOL in patients with Rheumatoid arthritis - SAQRA study | rheumatoid arthritis | Treatment with Tocilizumab | Juntendo University, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 1941 | JPRN-UMIN000007786 | 2012/05/01 | 19/04/2012 | "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " | "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " - Effect examination of infliximab to an anti-TNF invalid example | Rheumatoid Arthritis | infliximab plus methotrexate | Saitama Medical Center. Saitama Medical University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 40 | Not applicable | Japan |
| 1942 | NCT01618968 (ClinicalTrials.gov) | May 2012 | 4/6/2012 | Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device | Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Drug: MTX | Antares Pharma Inc. | NULL | Completed | 18 Years | N/A | All | 49 | Phase 2 | United States |
| 1943 | NCT01638715 (ClinicalTrials.gov) | May 2012 | 3/7/2012 | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | Rheumatoid Arthritis | Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera | Medical University of Vienna | NULL | Completed | 18 Years | 75 Years | All | 115 | Phase 4 | Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia |
| 1944 | NCT01613079 (ClinicalTrials.gov) | May 2012 | 4/6/2012 | Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis | Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety. | Arthritis, Rheumatoid | Drug: Tripterygium wilfordii Hook F;Drug: Methotrexate | Peking Union Medical College Hospital | NULL | Completed | 18 Years | 65 Years | Both | 201 | Phase 2/Phase 3 | China |
| 1945 | NCT01617590 (ClinicalTrials.gov) | May 2012 | 28/5/2012 | Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research | A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: leflunomide;Drug: methotrexate | Shanxi Medical University | NULL | Recruiting | 18 Years | 75 Years | Both | 500 | N/A | China |
| 1946 | NCT01724268 (ClinicalTrials.gov) | May 2012 | 7/11/2012 | Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient | Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study | RHEUMATOID ARTHRITIS | Drug: Pred + Meth;Drug: Anti TNF + Meth | Hamad Medical Corporation | NULL | Recruiting | 18 Years | N/A | Both | 80 | Phase 3 | Qatar |
| 1947 | NCT01664598 (ClinicalTrials.gov) | May 2012 | 10/8/2012 | An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 49 | Phase 3 | Russian Federation |
| 1948 | NCT01554917 (ClinicalTrials.gov) | May 2012 | 12/3/2012 | A Study of Iguratimod in Patients With Active Rheumatoid Arthritis | A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Iguratimod | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 1759 | Phase 4 | China |
| 1949 | NCT01617005 (ClinicalTrials.gov) | May 2012 | 8/6/2012 | A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs) | Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 50 | N/A | Montenegro |
| 1950 | NCT01668641 (ClinicalTrials.gov) | May 2012 | 14/8/2012 | Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: GLPG0634;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 70 Years | Both | 91 | Phase 2 | Hungary;Moldova, Republic of;Russian Federation;Ukraine |
| 1951 | NCT01548001 (ClinicalTrials.gov) | May 2012 | 5/3/2012 | Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 910 | Phase 4 | China |
| 1952 | NCT01576549 (ClinicalTrials.gov) | May 2012 | 10/4/2012 | A Study of LY2127399 in Rheumatoid Arthritis | An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States |
| 1953 | JPRN-UMIN000009535 | 2012/04/25 | 12/12/2012 | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate - SCRUM study | rheumatoid arthritis | We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation . MTX increase group was increased to 16mg, it will continue to increase as much as possible. We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation . MTX increase group was increased to 16mg, it will continue to increase as much as possible. We observe the patients if there is no positive joint power Doppler signal. | Osaka City University Medical School | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 120 | Not selected | Japan |
| 1954 | JPRN-UMIN000018017 | 2012/04/23 | 22/06/2015 | Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy | Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy - Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy | rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection | The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis. | Department of general internal medicine, Kyushu-University hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 70 | Not selected | Japan |
| 1955 | EUCTR2011-004529-28-HU (EUCTR) | 18/04/2012 | 01/03/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of | ||
| 1956 | EUCTR2011-001729-25-DE (EUCTR) | 11/04/2012 | 10/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1957 | JPRN-UMIN000011087 | 2012/04/11 | 01/07/2013 | Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates | Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates - Efficacy of monthly minodronate for osteoporosis in RA | Osteoporosis | Minodronic acid (50mg/month or 1mg/day) | Osaka University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 1958 | EUCTR2011-005021-48-PL (EUCTR) | 10/04/2012 | 14/03/2012 | A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX) | A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO | adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Teva Pharmaceutical Industries | NULL | Not Recruiting | Female: yes Male: yes | 544 | Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of | |||
| 1959 | EUCTR2011-002392-41-BG (EUCTR) | 09/04/2012 | 07/02/2012 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | ||
| 1960 | EUCTR2011-001729-25-CZ (EUCTR) | 03/04/2012 | 03/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1961 | JPRN-UMIN000007432 | 2012/04/01 | 02/03/2012 | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. - PRISM Study | rheumatoid arthritis | Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. | Keio University | NULL | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 100 | Not selected | Japan |
| 1962 | JPRN-UMIN000007380 | 2012/04/01 | 01/05/2012 | Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis | Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis - Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis | rheumatoid arthritis | tocilizumab + methotrexate (10mg/week) high-dose methotrexate (stepwisely increased to 16mg/week) | Kinki University Faculty of Medicine, Division of Hematology and Rheumatology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 1963 | NCT01484561 (ClinicalTrials.gov) | April 2012 | 30/11/2011 | A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis | A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550 or Placebo;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 148 | Phase 1 | United States;Czech Republic;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Spain |
| 1964 | NCT01569074 (ClinicalTrials.gov) | April 2012 | 30/3/2012 | Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis | (OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Fostamatinib;Drug: Placebo | AstraZeneca | NULL | Terminated | 18 Years | N/A | All | 163 | Phase 2 | Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam |
| 1965 | NCT01655381 (ClinicalTrials.gov) | April 2012 | 30/7/2012 | A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis | A Multicenter, Open-label, Single Arm, Long-term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 15 | Phase 3 | France |
| 1966 | NCT01579890 (ClinicalTrials.gov) | April 2012 | 16/4/2012 | Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis | A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis | Osteoarthritis of the Hand | Drug: Diclofenac | Mallinckrodt | Nuvo Research Inc. | Approved for marketing | N/A | N/A | Both | N/A | NULL | |
| 1967 | NCT01583959 (ClinicalTrials.gov) | April 2012 | 15/3/2012 | Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Folic Acid;Drug: Placebo | Postgraduate Institute of Medical Education and Research | NULL | Completed | 18 Years | 75 Years | Both | 100 | Phase 4 | India |
| 1968 | NCT01590459 (ClinicalTrials.gov) | April 2012 | 27/4/2012 | 24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate | A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension | Rheumatoid Arthritis | Drug: VX-509;Drug: VX-509 matching placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 80 Years | Both | 359 | Phase 2 | United States;Argentina;Bulgaria;Czech Republic;Estonia;Germany;Hungary;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine |
| 1969 | NCT01563978 (ClinicalTrials.gov) | April 2012 | 23/3/2012 | Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis | OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: fostamatinib;Drug: placebo | AstraZeneca | NULL | Completed | 18 Years | N/A | All | 266 | Phase 2 | United States;Bulgaria;Czech Republic;Germany;Poland;South Africa;Ukraine;Argentina;Mexico;Peru |
| 1970 | NCT02171143 (ClinicalTrials.gov) | April 2012 | 18/6/2014 | A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis;Pharmacokinetics of ASP2409 | Drug: ASP2409;Drug: Placebo | Astellas Pharma Global Development, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 58 | Phase 1 | United States |
| 1971 | NCT02818361 (ClinicalTrials.gov) | April 2012 | 15/6/2016 | Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis | Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Topical tripterygium gel;Drug: Placebo gel | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 70 | N/A | China |
| 1972 | EUCTR2011-004171-36-ES (EUCTR) | 30/03/2012 | 30/01/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of | |||
| 1973 | EUCTR2011-004171-36-PL (EUCTR) | 29/03/2012 | 22/02/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 1974 | EUCTR2011-002392-41-HU (EUCTR) | 28/03/2012 | 16/12/2011 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | ||
| 1975 | EUCTR2010-021184-32-EE (EUCTR) | 23/03/2012 | 08/03/2012 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 1976 | EUCTR2011-001729-25-HU (EUCTR) | 22/03/2012 | 26/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1977 | NCT01526057 (ClinicalTrials.gov) | March 20, 2012 | 1/2/2012 | A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01) | A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES | Rheumatoid Arthritis | Biological: PF-05280586;Biological: MabThera;Biological: Rituxan | Pfizer | NULL | Completed | 18 Years | N/A | All | 220 | Phase 2 | United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan |
| 1978 | EUCTR2011-006001-10-IT (EUCTR) | 19/03/2012 | 14/03/2012 | Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response | Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response - | Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA*EV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA Trade Name: MABTHERA*EV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA | A.O. UNIVERSITARIA INTEGRATA DI VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Italy | |||
| 1979 | EUCTR2011-001729-25-ES (EUCTR) | 16/03/2012 | 27/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1980 | EUCTR2011-002275-41-CZ (EUCTR) | 15/03/2012 | 28/12/2011 | A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis. | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Czech Republic;Belgium | |||
| 1981 | EUCTR2011-004468-31-LT (EUCTR) | 14/03/2012 | 05/01/2012 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | |||
| 1982 | EUCTR2009-011791-30-HU (EUCTR) | 14/03/2012 | 19/01/2012 | A multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis | A randomised, double-blind, placebo-controlled, multiple dose trial of NNC0151-0000-0000 in subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 48 | Czech Republic;Hungary;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom | |||
| 1983 | EUCTR2011-003953-25-DE (EUCTR) | 13/03/2012 | 04/01/2012 | A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis. | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab Product Code: L04 AB04 INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Canada;Australia;Germany | |||
| 1984 | EUCTR2011-001729-25-IE (EUCTR) | 09/03/2012 | 12/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 1985 | EUCTR2011-001729-25-AT (EUCTR) | 08/03/2012 | 08/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 1986 | NCT01649999 (ClinicalTrials.gov) | March 1, 2012 | 23/7/2012 | A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects | Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: peficitinib;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 20 Years | 75 Years | All | 281 | Phase 2 | Japan |
| 1987 | JPRN-UMIN000017230 | 2012/03/01 | 22/04/2015 | Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) | Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) - Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) | Rheumatoid arthritis | Biologic treatment (tocilizumab) | Kyushu University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 1988 | NCT01612377 (ClinicalTrials.gov) | March 2012 | 22/2/2012 | Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis | A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone | Zalicus | NULL | Terminated | 18 Years | N/A | Both | 18 | Phase 2 | Serbia |
| 1989 | NCT01561313 (ClinicalTrials.gov) | March 2012 | 21/3/2012 | Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab. | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis. | Rheumatoid Arthritis | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 64 | Phase 2 | Belgium;Czech Republic |
| 1990 | NCT01582880 (ClinicalTrials.gov) | March 2012 | 10/4/2012 | Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis | The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis | Chemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune Diseases | Drug: Riboflavin | Joseph B. Ciolino, MD | NULL | Completed | 18 Years | N/A | All | 1 | Phase 1/Phase 2 | United States |
| 1991 | NCT01626573 (ClinicalTrials.gov) | March 2012 | 3/5/2012 | A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis | A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Itacitinib;Drug: Itacitinib Placebo | Incyte Corporation | NULL | Completed | 18 Years | 75 Years | All | 106 | Phase 2 | United States;Puerto Rico |
| 1992 | NCT01571219 (ClinicalTrials.gov) | March 2012 | 23/3/2012 | An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis | Biological: Infliximab | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 302 | Phase 3 | Korea, Republic of;United Kingdom |
| 1993 | NCT01565408 (ClinicalTrials.gov) | March 2012 | 21/3/2012 | Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis | Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 32 | Phase 1 | Germany;Russian Federation |
| 1994 | NCT01670045 (ClinicalTrials.gov) | March 2012 | 17/8/2012 | A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 43 | N/A | Indonesia;Greece |
| 1995 | EUCTR2011-004171-36-GB (EUCTR) | 24/02/2012 | 15/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 1996 | EUCTR2011-004171-36-HU (EUCTR) | 23/02/2012 | 16/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 1997 | EUCTR2011-002024-40-ES (EUCTR) | 16/02/2012 | 14/10/2011 | Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CCR1 Antagonist Product Code: BMS-817399 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2 | United States;Mexico;Argentina;Spain;South Africa;Russian Federation;Korea, Republic of | ||
| 1998 | EUCTR2011-004171-36-CZ (EUCTR) | 15/02/2012 | 30/11/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 1999 | EUCTR2011-004468-31-ES (EUCTR) | 10/02/2012 | 07/12/2011 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||
| 2000 | EUCTR2011-004468-31-PL (EUCTR) | 07/02/2012 | 10/02/2012 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | |||
| 2001 | EUCTR2011-004468-31-LV (EUCTR) | 06/02/2012 | 30/12/2011 | Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 2002 | EUCTR2011-000311-34-IT (EUCTR) | 03/02/2012 | 06/12/2011 | GO-AHEAD | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD | Active Axial Spondyloarthritis (SpA) MedDRA version: 14.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy | ||
| 2003 | EUCTR2011-004468-31-IT (EUCTR) | 02/02/2012 | 02/03/2012 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Other descriptive name: NA | CELLTRION, INC. | NULL | Not Recruiting | Female: yes Male: yes | 617 | Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina | |||
| 2004 | JPRN-UMIN000007205 | 2012/02/01 | 02/02/2012 | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis - The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis | Rheumatoid arthritis | 1) Tacrolimus Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained. The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on. However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects. | Juntendo University | NULL | Pending | 65years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 2005 | JPRN-UMIN000007019 | 2012/02/01 | 01/02/2012 | Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease | Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease - Treatment of AOSD by tocilizumab mono-therapy | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity | NULL | Complete: follow-up complete | 16years-old | 70years-old | Male and Female | 40 | Not selected | Japan |
| 2006 | NCT01534884 (ClinicalTrials.gov) | February 2012 | 8/2/2012 | Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis | Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: rituximab | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 154 | Phase 1 | Korea, Republic of |
| 2007 | NCT01395251 (ClinicalTrials.gov) | February 2012 | 12/7/2011 | Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis | Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone | Rheumazentrum Ruhrgebiet | NULL | Completed | 18 Years | N/A | Both | 130 | Phase 2/Phase 3 | Germany |
| 2008 | NCT01646385 (ClinicalTrials.gov) | February 2012 | 12/4/2012 | Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry | Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data | Rheumatoid Arthritis | Drug: etanercept;Drug: non-biologic anti-rheumatic drugs | Pfizer | NULL | Completed | 18 Years | N/A | All | 6393 | N/A | NULL |
| 2009 | NCT01567358 (ClinicalTrials.gov) | February 2012 | 23/3/2012 | Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate | Rheumatoid Arthritis | Biological: Infliximab | Nichi-Iko Pharmaceutical Co.,Ltd. | NULL | Completed | 20 Years | 75 Years | Both | 14 | Phase 1 | Japan |
| 2010 | NCT01613027 (ClinicalTrials.gov) | February 2012 | 25/5/2012 | An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis | A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi) | Rheumatoid Arthritis | Biological: Rituximab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 135 | N/A | Greece |
| 2011 | NCT01438892 (ClinicalTrials.gov) | February 2012 | 20/9/2011 | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Rheumatoid Arthritis | Drug: tDMARDs;Drug: biodmards | Pfizer | NULL | Completed | 18 Years | N/A | Both | 396 | N/A | United States |
| 2012 | NCT01562327 (ClinicalTrials.gov) | February 2012 | 21/3/2012 | A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis | A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 50 | N/A | Argentina |
| 2013 | NCT01587989 (ClinicalTrials.gov) | February 2012 | 12/3/2012 | A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate | A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6) | Rheumatoid Arthritis | Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 77 | Phase 3 | Austria |
| 2014 | NCT01940926 (ClinicalTrials.gov) | February 2012 | 9/9/2013 | 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis | Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 68Ga-BNOTA-PRGD2 | Peking Union Medical College Hospital | NULL | Unknown status | 18 Years | N/A | All | 50 | Early Phase 1 | China |
| 2015 | NCT01623752 (ClinicalTrials.gov) | February 2012 | 18/6/2012 | Prospective Evaluation of the Radiographic Efficacy of Enbrel | A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS. | Rheumatoid Arthritis;Psoriasis Arthritis | Drug: Etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 1821 | NULL | |
| 2016 | EUCTR2011-002275-41-BE (EUCTR) | 31/01/2012 | 06/01/2012 | A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis. | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis. | Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Czech Republic;Belgium | |||
| 2017 | EUCTR2011-004468-31-AT (EUCTR) | 26/01/2012 | 30/11/2011 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland | |||
| 2018 | EUCTR2010-023782-22-SK (EUCTR) | 25/01/2012 | 07/10/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 2019 | EUCTR2011-002849-36-LV (EUCTR) | 12/01/2012 | 22/11/2011 | A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-39758979-AAC - enteric coated tablet - 10 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 30 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 100 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan | ||
| 2020 | EUCTR2011-004468-31-GB (EUCTR) | 06/01/2012 | 25/11/2011 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Phase 3 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||
| 2021 | JPRN-UMIN000012613 | 2012/01/01 | 20/12/2013 | Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. | Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. - Reduction of etanercept after remission in RA patients. | rheumatoid arthritis | etanercept50mg/wk or25mg twice/wk reduction of etanercept to 25mg/wk arfter 3 months from remission | Dept. of orthopedic surgery, Osaka Medical College | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 30 | Not selected | Japan |
| 2022 | ChiCTR-TRC-12001859 | 2012-01-01 | 2012-01-04 | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | coronary heart disease in rheumatoid arthritis | 1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo; | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | NULL | Completed | 18 | 65 | Both | 1:30;2:30; | China | |
| 2023 | NCT02922192 (ClinicalTrials.gov) | January 1, 2012 | 28/9/2016 | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis | Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics | Biologics & Biosimilars Collective Intelligence Consortium | HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of Pittsburgh | Completed | 18 Years | N/A | All | 90360 | NULL | |
| 2024 | NCT01474291 (ClinicalTrials.gov) | January 2012 | 15/11/2011 | An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice | Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 608 | N/A | France;Monaco |
| 2025 | NCT01506661 (ClinicalTrials.gov) | January 2012 | 5/1/2012 | Safety of Zostavax Vaccination in Rheumatoid Arthritis | Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis;Varicella Zoster | Drug: Zostavax (varicella zoster virus) vaccine | Oklahoma Medical Research Foundation | NULL | Completed | 50 Years | 80 Years | All | 20 | Phase 1 | United States |
| 2026 | NCT01519791 (ClinicalTrials.gov) | January 2012 | 19/1/2012 | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol;Other: Placebo;Biological: Methotrexate | UCB Pharma SA | NULL | Completed | 18 Years | N/A | All | 880 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic |
| 2027 | NCT01521923 (ClinicalTrials.gov) | January 2012 | 19/1/2012 | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 359 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic |
| 2028 | NCT01502423 (ClinicalTrials.gov) | January 2012 | 1/12/2011 | A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab | A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 61 | Phase 2 | Australia;Canada;Germany |
| 2029 | EUCTR2011-004468-31-SK (EUCTR) | 30/12/2011 | 04/01/2012 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||||
| 2030 | EUCTR2010-023782-22-BG (EUCTR) | 21/12/2011 | 21/05/2012 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 2031 | EUCTR2011-002633-19-DE (EUCTR) | 21/12/2011 | 02/08/2011 | Prednisolone test for patients with an inflammatory joint disease | Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort | rheumatoid arthritis MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Product Name: Paracetamol INN or Proposed INN: PARACETAMOL | Rheumazentrum Ruhrgebiet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 2032 | EUCTR2010-023782-22-ES (EUCTR) | 16/12/2011 | 20/07/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer, S.L.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland | ||
| 2033 | EUCTR2010-023782-22-DE (EUCTR) | 13/12/2011 | 16/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 2034 | EUCTR2009-016266-90-PT (EUCTR) | 09/12/2011 | 29/01/2010 | Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients | A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1740 | Belarus;United States;Portugal;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand | |||
| 2035 | EUCTR2011-000436-28-PL (EUCTR) | 07/12/2011 | 20/06/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation | ||
| 2036 | EUCTR2010-020065-24-GR (EUCTR) | 05/12/2011 | 04/11/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2800 | Phase 4 | United States;Serbia;Philippines;Greece;Ecuador;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany | ||
| 2037 | EUCTR2010-022208-36-PL (EUCTR) | 05/12/2011 | 08/04/2011 | An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P) | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1505 | Phase 3 | Germany;Malaysia;France;Bulgaria;Brazil;Australia;South Africa;New Zealand;Peru;Korea, Republic of;United States;Greece;Croatia;Poland;Hungary;Colombia;Italy;Lithuania;India;Russian Federation;Slovakia;Ukraine;Taiwan;Sri Lanka;Argentina;Mexico;Romania;Spain;Japan | ||
| 2038 | NCT01480388 (ClinicalTrials.gov) | December 2011 | 23/11/2011 | A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate | A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy | Active Rheumatoid Arthritis; Rheumatoid Arthritis | Drug: Placebo/JNJ-39758979 (300 mg/d);Drug: JNJ-39758979 (10 mg);Drug: JNJ-39758979 (30 mg);Drug: JNJ-39758979 (100 mg);Drug: JNJ-39758979 (300 mg) | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 2 | United States |
| 2039 | NCT01443364 (ClinicalTrials.gov) | December 2011 | 27/9/2011 | Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis | Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: Certolizumab pegol | UCB Italy s.p.a. | NULL | Completed | 18 Years | N/A | All | 132 | Phase 4 | Italy |
| 2040 | EUCTR2011-001220-38-DE (EUCTR) | 30/11/2011 | 21/07/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Belgium;Russian Federation;Germany;United Kingdom | |||
| 2041 | NCT01326962 (ClinicalTrials.gov) | November 30, 2011 | 7/3/2011 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF | Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 28 | Phase 3 | Saudi Arabia |
| 2042 | EUCTR2010-023956-99-CZ (EUCTR) | 29/11/2011 | 17/06/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014) | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil | ||
| 2043 | EUCTR2011-000275-13-BE (EUCTR) | 29/11/2011 | 20/10/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 2044 | EUCTR2011-005036-26-GB (EUCTR) | 29/11/2011 | 31/10/2011 | A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases | An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease | AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10003553;Term: Asthma;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FX125L | Funxional Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 2045 | EUCTR2010-023782-22-HU (EUCTR) | 22/11/2011 | 27/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 2046 | ChiCTR-TRC-11001789 | 2011-11-14 | 2011-12-12 | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Rheumatoid Arthritis | Treatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF); | Anhui Provincial Hospital Department of Rheumatism | NULL | Completed | 18 | 65 | Both | Treatment:140;Control:140; | China | |
| 2047 | EUCTR2010-024516-34-BG (EUCTR) | 09/11/2011 | 07/09/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Slovakia;Canada;Bulgaria;Italy | |||
| 2048 | EUCTR2011-000102-21-BG (EUCTR) | 09/11/2011 | 01/09/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 2049 | JPRN-UMIN000006653 | 2011/11/01 | 04/11/2011 | Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US- | Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US- - TM Stem Registry Study -Multicenter clinical research in Japan and US | Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc. | Trabecular Metal Primary Hip Prosthesis by THA | Shonan Kamakura Joint Reconstruction Center | NULL | Complete: follow-up continuing | 18years-old | Not applicable | Male and Female | 100 | Not applicable | Japan,North America |
| 2050 | NCT01592292 (ClinicalTrials.gov) | November 2011 | 11/4/2012 | An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy | A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent | Rheumatoid Arthritis | Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab | Hoffmann-La Roche | NULL | Completed | 20 Years | N/A | All | 90 | N/A | Korea, Republic of |
| 2051 | NCT01251120 (ClinicalTrials.gov) | November 2011 | 30/11/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis | A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 4 | Finland |
| 2052 | NCT01468077 (ClinicalTrials.gov) | November 2011 | 7/11/2011 | A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment | Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 47 | Phase 2 | Denmark;Iceland |
| 2053 | NCT01469013 (ClinicalTrials.gov) | November 2011 | 8/11/2011 | Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Baricitinib;Drug: Methotrexate | Eli Lilly and Company | NULL | Completed | 20 Years | 75 Years | All | 145 | Phase 2 | Japan |
| 2054 | EUCTR2010-020992-21-SK (EUCTR) | 26/10/2011 | 06/12/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany | ||
| 2055 | EUCTR2009-016266-90-BE (EUCTR) | 25/10/2011 | 22/08/2011 | Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients | A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1594 | Phase 2;Phase 3 | Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Romania;Germany;New Zealand | ||
| 2056 | EUCTR2011-000102-21-DE (EUCTR) | 20/10/2011 | 09/08/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NARTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 2057 | EUCTR2010-020992-21-ES (EUCTR) | 17/10/2011 | 28/05/2012 | Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide | Estudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos - AB1010 en tratamiento de pacientes con artritis reumatoide activa. | Atritis Reumatoide MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: no aplica Trade Name: Methotrexate Product Name: Methotrexate Product Code: no aplica INN or Proposed INN: METHOTREXATE Other descriptive name: no aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic | |||
| 2058 | EUCTR2010-020992-21-CZ (EUCTR) | 12/10/2011 | 18/07/2011 | Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis | A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis. | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India | ||
| 2059 | EUCTR2011-000436-28-BG (EUCTR) | 07/10/2011 | 06/10/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 2060 | EUCTR2010-019912-18-BG (EUCTR) | 03/10/2011 | 25/08/2011 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand | |||
| 2061 | NCT01359943 (ClinicalTrials.gov) | October 2011 | 19/5/2011 | Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate | A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate | Rheumatoid Arthritis | Biological: secukinumab (AIN457);Drug: placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 221 | Phase 2 | United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia |
| 2062 | NCT01436370 (ClinicalTrials.gov) | October 2011 | 15/9/2011 | TIV and High Dose TIV in Subjects With Rheumatoid Arthritis | A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels | Influenza | Biological: Trivalent inactivated influenza vaccine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 64 Years | All | 102 | Phase 2 | United States |
| 2063 | NCT01463059 (ClinicalTrials.gov) | October 2011 | 27/10/2011 | Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy | Rheumatoid Arthritis | Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg | UCB Japan Co. Ltd. | NULL | Completed | 20 Years | N/A | Both | 119 | Phase 2 | Japan;Korea, Republic of;Taiwan |
| 2064 | NCT01961505 (ClinicalTrials.gov) | October 2011 | 23/9/2013 | Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis | A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis. | Active Rheumatoid Arthritis | Drug: Topical compound tripterygium;Drug: Placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 70 | N/A | NULL |
| 2065 | NCT01292616 (ClinicalTrials.gov) | October 2011 | 8/2/2011 | Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement | Rheumatoid Arthritis | Drug: therapy with disease-modifying anti rheumatic drugs (DMARD) | University of Zurich | NULL | Recruiting | 18 Years | N/A | Both | 15 | N/A | Switzerland | |
| 2066 | NCT01557322 (ClinicalTrials.gov) | October 2011 | 8/2/2012 | Characterize Patients With Moderately Active Rheumatoid Arthritis (RA) | Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: etanercept;Drug: methotrexate (MTX) | Pfizer | NULL | Completed | 18 Years | N/A | All | 1754 | N/A | NULL |
| 2067 | NCT01641952 (ClinicalTrials.gov) | October 2011 | 13/7/2012 | An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent | Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program | Rheumatoid Arthritis | Drug: Rituximab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 505 | N/A | Romania |
| 2068 | NCT01439204 (ClinicalTrials.gov) | October 2011 | 21/9/2011 | Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb | A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects | Rheumatoid Arthritis | Biological: Abatacept (BMS-188667) | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 223 | Phase 1 | United States |
| 2069 | EUCTR2010-024516-34-SK (EUCTR) | 29/09/2011 | 13/04/2012 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Slovakia;Canada;Bulgaria;Italy | |||
| 2070 | EUCTR2010-020065-24-BE (EUCTR) | 26/09/2011 | 16/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | United States;Serbia;Philippines;Greece;Ecuador;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany | ||
| 2071 | EUCTR2010-023956-99-DE (EUCTR) | 22/09/2011 | 01/06/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 2072 | EUCTR2011-000102-21-SK (EUCTR) | 22/09/2011 | 28/06/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 2073 | EUCTR2010-023782-22-CZ (EUCTR) | 21/09/2011 | 01/08/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 2074 | EUCTR2011-001220-38-BE (EUCTR) | 19/09/2011 | 30/08/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 2075 | EUCTR2010-023692-26-SK (EUCTR) | 09/09/2011 | 13/09/2011 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands | ||
| 2076 | EUCTR2010-023587-40-NL (EUCTR) | 06/09/2011 | 11/05/2011 | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain | |||
| 2077 | EUCTR2010-020065-24-DE (EUCTR) | 06/09/2011 | 30/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2800 | Phase 4 | United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany | ||
| 2078 | NCT01404585 (ClinicalTrials.gov) | September 2011 | 27/7/2011 | Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: BMS-817399 | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 123 | Phase 2 | United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain |
| 2079 | NCT01544101 (ClinicalTrials.gov) | September 2011 | 27/2/2012 | A Nutritional Intervention for Arthritis | A Nutritional Intervention for Arthritis | Rheumatoid Arthritis | Other: Vegan Diet;Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins | Physicians Committee for Responsible Medicine | NULL | Completed | 18 Years | N/A | Both | 32 | N/A | United States |
| 2080 | NCT01245439 (ClinicalTrials.gov) | September 2011 | 17/11/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 65 | Phase 3 | Turkey |
| 2081 | NCT01399697 (ClinicalTrials.gov) | September 2011 | 20/7/2011 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2) | Rheumatoid Arthritis | Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 261 | Phase 4 | Spain |
| 2082 | NCT01462162 (ClinicalTrials.gov) | September 2011 | 27/10/2011 | A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis | A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 122 | N/A | Spain |
| 2083 | NCT01417052 (ClinicalTrials.gov) | September 2011 | 12/8/2011 | A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis | A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: 50 mg LX3305 QD;Drug: 100 mg LX3305 QD;Drug: 150 mg LX3305 QD;Drug: 200 mg LX3305 QD;Drug: 250 mg LX3305 QD;Drug: 300 mg LX3305 QD;Drug: 400 mg LX3305 QD;Drug: 250 mg LX3305 BID;Drug: 500 mg LX3305 QD;Drug: Placebo | Lexicon Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 10 | Phase 1 | United States |
| 2084 | NCT01350804 (ClinicalTrials.gov) | September 2011 | 9/5/2011 | Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1) | A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1) | Rheumatoid Arthritis | Biological: AIN457;Biological: Placebo;Biological: Abatacept | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 551 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain |
| 2085 | NCT02076659 (ClinicalTrials.gov) | September 2011 | 24/2/2014 | Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients | A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: F8IL10;Drug: Methotrexate | Philogen S.p.A. | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 1 | Italy |
| 2086 | NCT01359150 (ClinicalTrials.gov) | September 2011 | 11/5/2011 | A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo | A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate | Rheumatoid Arthritis | Drug: CP-690,550;Drug: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 223 | Phase 2 | United States;Poland |
| 2087 | NCT01446978 (ClinicalTrials.gov) | September 2011 | 3/10/2011 | Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs | Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate | Vaccine Response Impaired | Biological: hepatitis A vaccine | Sormland County Council, Sweden | NULL | Active, not recruiting | 18 Years | N/A | Both | 150 | Phase 2 | Sweden |
| 2088 | NCT02164214 (ClinicalTrials.gov) | September 2011 | 4/7/2013 | Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)? | DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)? | Inflammatory Rheumatism;Psoriatic Arthritis;Rheumatoid Arthritis | Drug: etanercept Treatment | Assistance Publique Hopitaux De Marseille | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 3 | France |
| 2089 | NCT01393639 (ClinicalTrials.gov) | September 2011 | 13/6/2011 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug. | Rheumatoid Arthritis | Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 323 | Phase 2 | United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic |
| 2090 | EUCTR2010-019912-18-HU (EUCTR) | 31/08/2011 | 08/06/2011 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa | Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand | |||
| 2091 | EUCTR2010-020745-27-HU (EUCTR) | 31/08/2011 | 11/07/2011 | Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3) | A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany | ||
| 2092 | EUCTR2010-024516-34-HU (EUCTR) | 31/08/2011 | 29/06/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Canada;Bulgaria;Italy | |||
| 2093 | EUCTR2010-020065-24-NL (EUCTR) | 31/08/2011 | 06/07/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2094 | NCT01377012 (ClinicalTrials.gov) | August 30, 2011 | 17/6/2011 | Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa Agents | A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1) | Rheumatoid Arthritis | Biological: Secukinumab (AIN457);Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 637 | Phase 3 | United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania |
| 2095 | EUCTR2010-020065-24-ES (EUCTR) | 25/08/2011 | 01/07/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R. Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2800 | Phase 4 | United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany | ||
| 2096 | EUCTR2011-000385-35-IT (EUCTR) | 19/08/2011 | 27/02/2012 | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY - CZP-SPEED | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: CIMZIA INN or Proposed INN: CERTOLUZIMAB PEGOL Other descriptive name: NA | UCB PHARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 2097 | EUCTR2011-000102-21-CZ (EUCTR) | 19/08/2011 | 27/05/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 2098 | EUCTR2010-022378-15-GB (EUCTR) | 18/08/2011 | 10/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 2099 | EUCTR2010-023956-99-HU (EUCTR) | 17/08/2011 | 18/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 2100 | EUCTR2011-000102-21-ES (EUCTR) | 17/08/2011 | 04/07/2011 | Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfa | Estudio aleatorizado, doble ciego, controlado con placebo y con control activo de secukinumab para demostrar la eficacia en 24 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo durante 1 año en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada a anti-TNFalfa | ARTRITIS REUMATOIDE MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: NO APLICA Trade Name: ORENCIA 250 mg polvo para concentrado para sol. para perfusión INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 2101 | EUCTR2011-002363-15-IS (EUCTR) | 17/08/2011 | 22/06/2011 | A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis. | Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST | Adult Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 56 | Denmark;Iceland | |||
| 2102 | EUCTR2011-002363-15-DK (EUCTR) | 16/08/2011 | 27/07/2011 | A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis. | Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST | Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 56 | Denmark;Iceland | |||
| 2103 | EUCTR2010-020065-24-GB (EUCTR) | 15/08/2011 | 08/04/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2104 | EUCTR2010-021184-32-IT (EUCTR) | 03/08/2011 | 02/02/2011 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies | Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany | ||
| 2105 | NCT01331837 (ClinicalTrials.gov) | August 2, 2011 | 7/4/2011 | A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors | A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 3080 | Phase 4 | United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Canada;Chile;Croatia;Czechia;Ecuador;France;Germany;Greece;Hungary;India;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;United Kingdom;Brazil;China;Czech Republic |
| 2106 | EUCTR2011-000436-28-HU (EUCTR) | 02/08/2011 | 10/08/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 2107 | NCT01426789 (ClinicalTrials.gov) | August 2011 | 12/8/2011 | A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients | A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension | Rheumatoid Arthritis | Drug: Placebo;Drug: Secukinumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | United States;Belgium;Germany;Russian Federation;United Kingdom |
| 2108 | NCT01295151 (ClinicalTrials.gov) | August 2011 | 11/2/2011 | SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. | Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug | Rheumatoid Arthritis | Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab | Julia Brown | NULL | Completed | 18 Years | N/A | Both | 122 | Phase 4 | United Kingdom |
| 2109 | NCT01442545 (ClinicalTrials.gov) | August 2011 | 23/8/2011 | A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | A Study to Investigate the Effect of Multiple Doses of JNJ 39758979 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Patients on a Stable Methotrexate Dose | Rheumatoid Arthritis | Drug: JNJ-39758979 / MTX | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 18 Years | 75 Years | Both | 21 | Phase 1 | United States;Germany |
| 2110 | NCT01414101 (ClinicalTrials.gov) | August 2011 | 21/7/2011 | Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ISIS CRP Rx or Placebo | Isis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 51 | Phase 2 | Canada;Russian Federation |
| 2111 | NCT01390545 (ClinicalTrials.gov) | August 2011 | 5/7/2011 | VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis | VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate. | Rheumatoid Arthritis | Drug: Veltuzumab | Takeda | NULL | Terminated | 18 Years | N/A | Both | 300 | Phase 2 | United States;Argentina;Canada;Czech Republic;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom |
| 2112 | JPRN-UMIN000013750 | 2011/07/31 | 21/04/2014 | Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis | Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis - Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis | Rheumatoid arthritis, Periodontitis | IL-6 receptor inhibition group: Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. TNF inhibition group: Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. | Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 80 | Not selected | Japan |
| 2113 | EUCTR2011-000275-13-HU (EUCTR) | 29/07/2011 | 10/06/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 2114 | EUCTR2010-023956-99-NL (EUCTR) | 28/07/2011 | 30/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011) | RHEUMATOID ARTHRITIS,NOS MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2115 | EUCTR2011-001863-39-AT (EUCTR) | 28/07/2011 | 15/06/2011 | A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX. | A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE | Mild to moderate rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexat Lederle 2.5mg tablets Product Name: Methotrexat Product Code: RO0029893 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium | Roche Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 2116 | EUCTR2010-020065-24-AT (EUCTR) | 28/07/2011 | 17/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2117 | EUCTR2010-020065-24-CZ (EUCTR) | 26/07/2011 | 27/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2118 | NCT01382940 (ClinicalTrials.gov) | July 26, 2011 | 24/6/2011 | A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis | A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamine | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 351 | Phase 4 | United States |
| 2119 | EUCTR2010-022206-40-PL (EUCTR) | 26/07/2011 | 11/04/2011 | A Rheumatoid Arthritis Study in Patients (FLEX-O) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 3 | United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of | ||
| 2120 | EUCTR2010-020065-24-LT (EUCTR) | 25/07/2011 | 25/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | |||
| 2121 | EUCTR2010-024516-34-IT (EUCTR) | 25/07/2011 | 29/12/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F Other descriptive name: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Canada;Bulgaria;Italy | |||
| 2122 | EUCTR2010-022207-22-PL (EUCTR) | 22/07/2011 | 11/04/2011 | A Study in Patients With Rheumatoid Arthritis(FLEX-V) | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | Germany;Colombia;Malaysia;Italy;Australia;Brazil;Russian Federation;New Zealand;Argentina;Mexico;Taiwan;Korea, Republic of;Spain;Japan;Greece;United States;Poland | ||
| 2123 | EUCTR2010-023956-99-BE (EUCTR) | 20/07/2011 | 24/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 2124 | EUCTR2011-000275-13-GB (EUCTR) | 20/07/2011 | 18/07/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 2125 | EUCTR2010-023956-99-ES (EUCTR) | 20/07/2011 | 03/11/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) - | RHEUMATOID ARTHRITIS,NOS MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 677 | Phase 2 | Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States | ||
| 2126 | EUCTR2010-022205-17-PL (EUCTR) | 19/07/2011 | 08/04/2011 | A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy(FLEX-M) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Trade Name: Boostrix® Product Name: Boostrix® Product Code: - Other descriptive name: DIPHTHERIA TOXOID Other descriptive name: TETANUS TOXOID Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE Trade Name: PNEUMOVAX® 23 Product Name: PNEUMOVAX® 23 Product Code: - Other descriptive name: pneumococcal serotypes | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 990 | Phase 3 | Hungary;Colombia;Malaysia;Bulgaria;South Africa;Australia;Brazil;Lithuania;India;Slovakia;Russian Federation;Ukraine;New Zealand;Peru;Taiwan;Sri Lanka;Mexico;Argentina;Romania;Korea, Republic of;Japan;United States;Croatia;Poland | ||
| 2127 | EUCTR2011-000102-21-HU (EUCTR) | 14/07/2011 | 08/06/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 2128 | EUCTR2011-001220-38-GB (EUCTR) | 12/07/2011 | 17/05/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 2129 | EUCTR2010-023956-99-IT (EUCTR) | 11/07/2011 | 01/03/2012 | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate | RHEUMATOID ARTHRITIS,NOS MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-Interleukin-6 Monoclonal Product Code: BMS-945429 INN or Proposed INN: NA Other descriptive name: anti IL 6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: NA Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE | BRISTOL-M.SQUIBB | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2130 | JPRN-jRCTs032180273 | 11/07/2011 | 14/03/2019 | Wear of OXINIUM on XLPE: Multicenter RCT Study | Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study | Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis | Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE) | Akiyama Haruhiko | NULL | Not Recruiting | >= 20age old | <= 75age old | Both | 1308 | Phase 4 | Japan |
| 2131 | EUCTR2009-016266-90-AT (EUCTR) | 06/07/2011 | 31/05/2011 | Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients | A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1594 | Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand | |||
| 2132 | JPRN-JapicCTI-111628 | 01/7/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate. | Rheumatoid Arthritis | Intervention name : Clazakizumab Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg Control intervention name : Methotrexate,Adalimumab Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg | Bristol-Myers K.K. | NULL | 18 | BOTH | 406 | Phase 2 | NULL | |||
| 2133 | NCT02433184 (ClinicalTrials.gov) | July 2011 | 23/4/2015 | Very Early Versus Delayed Etanercept in Patients With RA | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine | University of Leeds | NULL | Completed | 18 Years | 80 Years | All | 120 | Phase 4 | United Kingdom |
| 2134 | NCT01390441 (ClinicalTrials.gov) | July 2011 | 7/7/2011 | A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002) | A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 65 Years | All | 100 | Phase 1 | Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States |
| 2135 | NCT01410695 (ClinicalTrials.gov) | July 2011 | 4/8/2011 | Masitinib in Refractory Active Rheumatoid Arthritis | A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs | Rheumatoid Arthritis (RA) | Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib) | AB Science | NULL | Terminated | 18 Years | N/A | All | 324 | Phase 2/Phase 3 | Czechia;Czech Republic;France;United States |
| 2136 | EUCTR2010-021283-14-HU (EUCTR) | 29/06/2011 | 27/04/2011 | A randomised, double blind, placebo-controlled trial with multiple doses of Anti-IL-20 in subjects with rheumatoid arthritis | A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 66 | Portugal;Hungary;United Kingdom;Spain;Italy | |||
| 2137 | EUCTR2011-000102-21-IT (EUCTR) | 28/06/2011 | 09/01/2012 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: Secukinumab Trade Name: ORENCIA*IV 2FL 250MG+2SIR INN or Proposed INN: ABATACEPT | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 2138 | EUCTR2011-000275-13-IT (EUCTR) | 28/06/2011 | 23/02/2012 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs. | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 2139 | EUCTR2010-019262-86-ES (EUCTR) | 22/06/2011 | 21/04/2010 | Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) | Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) | Artritis Reumatoide_______________________Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Netherlands;Germany;Norway;Sweden | ||
| 2140 | EUCTR2010-022208-36-GR (EUCTR) | 21/06/2011 | 16/05/2011 | An Open Label Study for Patients With Rheumatoid Arthritis | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1505 | Phase 3 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;Malaysia;Australia;Peru;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 2141 | EUCTR2010-019262-86-IT (EUCTR) | 17/06/2011 | 06/09/2011 | Long term evaluation of SAR153191 (REGN88) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SAR153191 | SANOFI-AVENTIS S.P.A | NULL | Not Recruiting | Female: yes Male: yes | 1696 | Phase 3 | Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Australia;Peru;South Africa;Netherlands;Finland;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Norway;Germany;New Zealand;Sweden | ||
| 2142 | EUCTR2011-000107-40-GB (EUCTR) | 16/06/2011 | 10/03/2011 | A 12 weeks study to evaluate effect of revamilst in addition tomethotrexate in rheumatiod arthritis patients. | A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate. | Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast | Glenmark Pharmaceuticals SA | NULL | Not Recruiting | Female: yes Male: yes | 406 | Phase 2 | Philippines;Poland;Sri Lanka;United Kingdom;India | ||
| 2143 | EUCTR2010-020065-24-HU (EUCTR) | 15/06/2011 | 02/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2144 | EUCTR2010-023587-40-DE (EUCTR) | 14/06/2011 | 02/03/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden | |||
| 2145 | ChiCTR-DDT-12002268 | 2011-06-11 | 2012-06-11 | Early diagnosis of rheumatoid arthritis | Study on the clinical application of imaging in early rheumatoid | rheumatoid arthritis | Gold Standard:;Index test:; | Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical University | NULL | Completed | 18 | 65 | Both | Target condition:0;Difficult condition:0 | China | |
| 2146 | EUCTR2008-001523-57-NO (EUCTR) | 10/06/2011 | 23/09/2008 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Denmark;Germany;Norway;France;Hungary;Spain;Italy;United Kingdom | ||
| 2147 | EUCTR2010-022207-22-DE (EUCTR) | 08/06/2011 | 03/12/2010 | A Study in Patients With Rheumatoid Arthritis (FLEX-V) | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V) | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Other descriptive name: not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Other descriptive name: not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 555 | Phase 3 | United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of | ||
| 2148 | EUCTR2010-021184-32-BE (EUCTR) | 08/06/2011 | 14/04/2011 | GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy | A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti- TNF therapies | Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the US Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Hexal AG | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 2 | Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany | ||
| 2149 | EUCTR2010-020065-24-LV (EUCTR) | 08/06/2011 | 11/05/2011 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 3080 | Phase 4 | Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany | ||
| 2150 | EUCTR2010-022208-36-DE (EUCTR) | 08/06/2011 | 03/12/2010 | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1505 | Phase 3 | Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 2151 | EUCTR2011-000215-79-FR (EUCTR) | 07/06/2011 | 24/02/2011 | Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA | Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA | Polyarthrite rhumatoïde | Trade Name: Roactemra Other descriptive name: TOCILIZUMAB | CHU de Clermont Ferrand | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 2152 | EUCTR2010-022504-42-GB (EUCTR) | 07/06/2011 | 16/11/2010 | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibtor Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibtor | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Hungary;United Kingdom | ||
| 2153 | JPRN-UMIN000005590 | 2011/06/01 | 12/05/2011 | Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis | Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis - Maintenance of remission by tocilizumab mono-therapy | Rheumatoid arthritis | Cessation of MTX (tocilizumab monotherapy) Continue MTX with tocilizumab | Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 40 | Not selected | Japan |
| 2154 | EUCTR2007-000012-90-NL (EUCTR) | 01/06/2011 | 18/10/2010 | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid | Trade Name: Celebrex Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses | University of Dundee | NULL | Not Recruiting | Female: yes Male: yes | Denmark;Netherlands;United Kingdom | ||||
| 2155 | JPRN-UMIN000005773 | 2011/06/01 | 14/06/2011 | Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis | Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis - Quantification of knee cartilage in rheumatoid arthritis by MRI analysis | rheumatoid arthritis | ETN+MTX MTX | 22nd Century Medical & Research Center, the University of Tokyo | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan |
| 2156 | NCT01369745 (ClinicalTrials.gov) | June 2011 | 7/6/2011 | A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo | Zalicus | NULL | Completed | 18 Years | N/A | All | 294 | Phase 2 | United States |
| 2157 | NCT01405118 (ClinicalTrials.gov) | June 2011 | 7/7/2011 | Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers | A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers | Rheumatoid Arthritis | Drug: Metformin/CP-690,550 | Pfizer | NULL | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | Belgium |
| 2158 | NCT01355354 (ClinicalTrials.gov) | June 2011 | 17/5/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects | An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Healthy Volunteers;Rheumatoid Arthritis | Drug: Digoxin;Drug: Fostamatinib | AstraZeneca | NULL | Completed | 18 Years | 45 Years | Both | 21 | Phase 1 | United Kingdom |
| 2159 | NCT01384422 (ClinicalTrials.gov) | June 2011 | 27/6/2011 | Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: GLPG0634 | Galapagos NV | NULL | Completed | 18 Years | 70 Years | Both | 36 | Phase 2 | Moldova, Republic of | |
| 2160 | NCT01450982 (ClinicalTrials.gov) | June 2011 | 13/6/2011 | A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose | Rheumatoid Arthritis | Drug: JNJ-38518168 / MTX | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 18 Years | 75 Years | Both | 20 | Phase 1 | United States |
| 2161 | NCT01373151 (ClinicalTrials.gov) | June 2011 | 13/6/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate. | Rheumatoid Arthritis | Drug: BMS-945429 Placebo;Biological: BMS-945429;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Adalimumab Placebo;Drug: Adalimumab | CSL Behring | NULL | Completed | 18 Years | N/A | All | 418 | Phase 2 | United States;Argentina;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Czech Republic;Peru |
| 2162 | NCT01215942 (ClinicalTrials.gov) | June 2011 | 5/10/2010 | An Open Label Study for Participants With Rheumatoid Arthritis | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 1086 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;France;Germany;Greece;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sri Lanka;Taiwan;Ukraine;Italy;Peru |
| 2163 | EUCTR2010-022378-15-DE (EUCTR) | 25/05/2011 | 09/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 2164 | EUCTR2010-022378-15-ES (EUCTR) | 19/05/2011 | 21/02/2011 | A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 2165 | EUCTR2010-018485-24-DE (EUCTR) | 18/05/2011 | 28/01/2011 | To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 176 | Hungary;Czech Republic;Spain;Latvia;Germany | |||
| 2166 | EUCTR2010-021283-14-PT (EUCTR) | 13/05/2011 | 07/12/2010 | A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis | A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom | ||
| 2167 | JPRN-UMIN000024507 | 2011/05/12 | 21/10/2016 | Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis | Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis - Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis | rheumatoid arthritis | In these patients, who had received SASP/MTX combination therapy for at least 12 weeks, SASP was discontinued, and the patients received MTX monotherapy for the next 24 weeks. | Japan Community Healthcare Organization | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 10 | Not selected | Japan |
| 2168 | EUCTR2011-003016-23-IT (EUCTR) | 11/05/2011 | 07/03/2012 | Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy | Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY | Rheumatoid Arthritis MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guna-Anti Interleukin 1 Product Code: NA INN or Proposed INN: NA Other descriptive name: Guna-Antiinterleukin 1 alfa INN or Proposed INN: NA Other descriptive name: Guna-Antiinterleukin 1 beta Product Name: Interleukin 10 Product Code: NA INN or Proposed INN: NA Other descriptive name: Guna-Interleukin 10 Product Name: Interleukin 4 Product Code: NA INN or Proposed INN: NA Other descriptive name: Guna-Interleukin 4 | GUNA SPA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 2169 | EUCTR2010-022224-77-BE (EUCTR) | 10/05/2011 | 14/01/2011 | Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 2170 | EUCTR2010-020839-39-BE (EUCTR) | 10/05/2011 | 25/11/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc. A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Belgium;United Kingdom | ||
| 2171 | EUCTR2010-023587-40-GR (EUCTR) | 10/05/2011 | 16/05/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden | |||
| 2172 | EUCTR2010-019871-31-CZ (EUCTR) | 10/05/2011 | 01/03/2011 | Etoricoxib and placebo in patients with rheumatoid arthritis | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou | Rheumatoid Arthritis (RA) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 2173 | EUCTR2009-013758-33-NL (EUCTR) | 10/05/2011 | 16/09/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 2174 | EUCTR2009-015019-42-DE (EUCTR) | 10/05/2011 | 20/08/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | |||
| 2175 | EUCTR2010-023587-40-SE (EUCTR) | 04/05/2011 | 14/03/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor | A randomized, open-label, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 96 | United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden | |||
| 2176 | EUCTR2009-016266-90-ES (EUCTR) | 03/05/2011 | 16/12/2009 | Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY | Artritis Reumatoide_____________________________________Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 1740 | Phase 2 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands | ||
| 2177 | EUCTR2010-019871-31-SK (EUCTR) | 02/05/2011 | 28/02/2011 | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis | A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term: | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom | ||
| 2178 | NCT01262118 (ClinicalTrials.gov) | May 2011 | 15/11/2010 | Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis | An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550 (tasocitinib) | Pfizer | NULL | Completed | 18 Years | N/A | All | 69 | Phase 1 | United States;Hungary |
| 2179 | NCT01329991 (ClinicalTrials.gov) | May 2011 | 4/4/2011 | Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate | A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate | Rheumatoid Arthritis | Drug: PLX5622;Drug: Placebo | Plexxikon | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 1 | United States |
| 2180 | NCT01347983 (ClinicalTrials.gov) | May 2011 | 3/5/2011 | Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Tocilizumab+Methotrexate(MTX) | Chugai Pharma Taiwan | NULL | Completed | 20 Years | 75 Years | Both | 72 | Phase 3 | Taiwan |
| 2181 | NCT01370902 (ClinicalTrials.gov) | May 2011 | 31/5/2011 | Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | Inflammation;Rheumatoid Arthritis | Drug: NNC 0141-0000-0100;Drug: placebo | Innate Pharma | NULL | Completed | 18 Years | 75 Years | Both | 92 | Phase 1 | Germany |
| 2182 | NCT01283971 (ClinicalTrials.gov) | May 2011 | 25/1/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor | A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folate | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 96 | Phase 4 | United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom |
| 2183 | NCT01404429 (ClinicalTrials.gov) | May 2011 | 26/7/2011 | Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis | Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate | Postgraduate Institute of Medical Education and Research | NULL | Completed | 18 Years | 65 Years | All | 100 | Phase 4 | India |
| 2184 | EUCTR2010-020065-24-IT (EUCTR) | 29/04/2011 | 20/03/2012 | A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease. | A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® INN or Proposed INN: TOCILIZUMAB Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 2800 | Phase 4 | United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany | ||
| 2185 | EUCTR2010-023587-40-DK (EUCTR) | 28/04/2011 | 12/04/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 4 | United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden | ||
| 2186 | EUCTR2010-022224-77-GB (EUCTR) | 27/04/2011 | 21/12/2010 | Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 2187 | EUCTR2010-019262-86-DE (EUCTR) | 26/04/2011 | 20/08/2010 | Long term evaluation of sarilumab in rheumatoid arthritis patients | A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 2025 | Phase 3 | Philippines;Taiwan;Estonia;United States;Portugal;Belarus;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden | ||
| 2188 | EUCTR2010-019514-24-CZ (EUCTR) | 21/04/2011 | 06/12/2010 | Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA) | A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO | Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX Goldshield Tablets INN or Proposed INN: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 380 | United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany | |||
| 2189 | EUCTR2010-019912-18-GR (EUCTR) | 18/04/2011 | 01/04/2011 | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis | Rheumatoid arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6; | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Greece;Spain;Bulgaria | |||
| 2190 | EUCTR2010-023587-40-FI (EUCTR) | 15/04/2011 | 24/02/2011 | A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 96 | Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden | |||
| 2191 | EUCTR2010-023587-40-ES (EUCTR) | 13/04/2011 | 17/02/2011 | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF. | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF. | Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 4 | Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden | ||
| 2192 | EUCTR2010-018485-24-ES (EUCTR) | 12/04/2011 | 04/11/2010 | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | Hungary;Czech Republic;Spain;Latvia;Germany | ||
| 2193 | EUCTR2010-021020-94-HU (EUCTR) | 08/04/2011 | 05/10/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SAR153191 Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 2194 | EUCTR2010-022378-15-HU (EUCTR) | 08/04/2011 | 21/02/2011 | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom | ||
| 2195 | EUCTR2010-023692-26-GB (EUCTR) | 07/04/2011 | 18/11/2010 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany | ||
| 2196 | EUCTR2008-007346-63-GB (EUCTR) | 05/04/2011 | 11/10/2010 | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP | Rheumatoid Arthritis | Product Name: bIAP Product Code: EC 3.1.3.1 INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP) Other descriptive name: bIAP | Alloksys Life Sciences B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 2197 | EUCTR2009-015019-42-BE (EUCTR) | 04/04/2011 | 06/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany | ||
| 2198 | EUCTR2010-019514-24-DE (EUCTR) | 04/04/2011 | 08/11/2010 | Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA) | A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO | Rheumatoid Arthritis. MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 380 | United States;Czech Republic;Puerto Rico;Canada;Argentina;Spain;Austria;Germany | |||
| 2199 | EUCTR2010-022206-40-LT (EUCTR) | 01/04/2011 | 28/12/2010 | A Rheumatoid Arthritis Study in Patients(FLEX-O) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 3 | United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand | ||
| 2200 | EUCTR2010-022208-36-LT (EUCTR) | 01/04/2011 | 28/12/2010 | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1505 | Phase 3 | Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 2201 | EUCTR2010-022205-17-LT (EUCTR) | 01/04/2011 | 28/12/2010 | A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 990 | Phase 3 | United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of | ||
| 2202 | JPRN-UMIN000005362 | 2011/04/01 | 01/04/2011 | Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). | Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). - Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs. | Patients with rheumatoid arthritis with anemia taking NSAIDs | Treatment with mesalazine | Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 13 | Not selected | Japan |
| 2203 | NCT01336218 (ClinicalTrials.gov) | April 2011 | 14/4/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects. | An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin | Rheumatoid Arthritis;Healthy Volunteers | Drug: fostamatinib;Drug: rifampicin | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United States |
| 2204 | EUCTR2010-023880-17-GB (EUCTR) | 31/03/2011 | 25/02/2011 | SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug | SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH | Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Mabthera Product Name: Rituximab Product Code: n/a INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of the world) Trade Name: Orencia Product Name: Abatacept Product Code: n/a INN or Proposed INN: abatacept Other descriptive name: Orencia Trade Name: Remicade Product Name: Infliximab Product Code: n/a INN or Proposed INN: infliximab Other descriptive name: n/a Trade Name: Enbrel Product Name: Etanercept Product Code: n/a INN or Proposed INN: etanercept Other descriptive name: n/a | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 477 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 2205 | EUCTR2010-022206-40-BG (EUCTR) | 30/03/2011 | 24/02/2011 | A Rheumatoid Arthritis Study in Patients (FLEX-O) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 3 | United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of | ||
| 2206 | EUCTR2010-022205-17-BG (EUCTR) | 29/03/2011 | 24/02/2011 | A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 Trade Name: Boostrix® Product Name: Boostrix® Product Code: - Other descriptive name: DIPHTHERIA TOXOID Other descriptive name: TETANUS TOXOID Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE Trade Name: PNEUMOVAX® 23 Product Name: PNEUMOVAX® 23 Product Code: - Other descriptive name: pneumococcal serotypes | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 990 | Phase 3 | United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of | ||
| 2207 | EUCTR2010-021558-21-GB (EUCTR) | 28/03/2011 | 08/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 | Asahi Kasei Pharma Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine | ||
| 2208 | EUCTR2010-021577-37-BG (EUCTR) | 24/03/2011 | 04/02/2011 | A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti Lymphotoxin Alpha Product Code: MLTA3698A Other descriptive name: Anti lymphotoxin alpha Trade Name: Humira INN or Proposed INN: ADALIMUMAB | GENENTECH, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany | ||
| 2209 | EUCTR2010-022208-36-BG (EUCTR) | 24/03/2011 | 24/02/2011 | An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P) | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P) | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1505 | Phase 3 | United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 2210 | EUCTR2010-023910-30-GB (EUCTR) | 23/03/2011 | 28/02/2011 | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA) | A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA) | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Enbrel 50mg pre-filled pen Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/020 INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Enbrel 50mg pre-filled syringe Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/017 INN or Proposed INN: Etanercept | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | United Kingdom | ||
| 2211 | EUCTR2010-021558-21-SK (EUCTR) | 23/03/2011 | 26/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 | Asahi Kasei Pharma Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine | ||
| 2212 | EUCTR2010-022208-36-ES (EUCTR) | 21/03/2011 | 29/12/2010 | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR) | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR) | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1505 | Phase 3 | Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 2213 | EUCTR2010-022207-22-ES (EUCTR) | 21/03/2011 | 29/12/2010 | A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa | A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa | Rheumatoid Arthritis Artritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 555 | Phase 3 | Greece;Poland;Spain;Germany;Italy | ||
| 2214 | EUCTR2010-023692-26-BG (EUCTR) | 17/03/2011 | 24/02/2011 | Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4) | (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4 | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 2 | Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany | ||
| 2215 | EUCTR2010-021577-37-DE (EUCTR) | 17/03/2011 | 29/10/2010 | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: N/A Product Code: MLTA3698A Trade Name: Humira INN or Proposed INN: ADALIMUMAB | GENENTECH, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Hungary;Spain;Bulgaria;Germany | ||
| 2216 | EUCTR2010-022378-15-CZ (EUCTR) | 16/03/2011 | 21/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 2217 | EUCTR2010-022207-22-GR (EUCTR) | 15/03/2011 | 20/01/2011 | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 555 | Phase 3 | Greece;Poland;Spain;Germany;Italy | ||
| 2218 | EUCTR2010-021020-94-DE (EUCTR) | 10/03/2011 | 15/09/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 2219 | EUCTR2010-023587-40-IT (EUCTR) | 10/03/2011 | 27/04/2011 | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND | A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra INN or Proposed INN: tocilizumab Trade Name: Humira INN or Proposed INN: Adalimumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden | |||
| 2220 | EUCTR2009-016055-22-SE (EUCTR) | 09/03/2011 | 11/01/2011 | Hepatitis A vaccine in patients with immunomodulative drugs | Hepatitis A vaccine in patients with immunomodulative drugs | Patients with rheumatoid arthritis treated with immunosuppressive medication MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy MedDRA version: 12.1;Classification code 10063430;Term: Hepatitis A immunisation | Trade Name: Epaxal Product Name: Epaxal Other descriptive name: Inactivated hepatitis A virus Trade Name: Havrix Product Name: Havrix Other descriptive name: inactivated hepatitis A virus | HY, HUS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 2221 | EUCTR2010-023469-22-NL (EUCTR) | 09/03/2011 | 02/12/2010 | A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA | A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: ARA290 Product Code: ARA290 | LUMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 2222 | EUCTR2010-022865-81-CZ (EUCTR) | 02/03/2011 | 22/12/2010 | Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis | A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 Other descriptive name: ALX-0061 Nanobody | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 1/2 | Hungary;Czech Republic | ||
| 2223 | NCT01313520 (ClinicalTrials.gov) | March 1, 2011 | 25/2/2011 | A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136) | A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136) | Arthritis, Rheumatoid | Drug: Infliximab;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 61 | Phase 2 | Moldova, Republic of;Romania |
| 2224 | NCT01309854 (ClinicalTrials.gov) | March 2011 | 21/2/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects | An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily | Rheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in Blood | Drug: fostamatinib;Drug: pioglitazone | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United States |
| 2225 | NCT01353859 (ClinicalTrials.gov) | March 2011 | 13/5/2011 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs | An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 39 | Phase 3 | Indonesia;Greece |
| 2226 | NCT01296711 (ClinicalTrials.gov) | March 2011 | 14/2/2011 | Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056 | A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056 | Rheumatoid Arthritis | Biological: CDP6038 | UCB BIOSCIENCES, Inc. | NULL | Completed | 18 Years | N/A | Both | 190 | Phase 2 | United States;Belgium;United Kingdom |
| 2227 | NCT01332994 (ClinicalTrials.gov) | March 2011 | 18/3/2011 | A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis | Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI) | Rheumatoid Arthritis | Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 519 | Phase 3 | Germany |
| 2228 | NCT01566201 (ClinicalTrials.gov) | March 2011 | 27/3/2012 | Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease | The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis | Rheumatoid Arthritis;Coronary Artery Disease;Inflammation | Drug: anakinra;Drug: placebo | University of Athens | NULL | Completed | 18 Years | N/A | Both | 80 | N/A | Greece |
| 2229 | NCT01301703 (ClinicalTrials.gov) | March 2011 | 21/2/2011 | Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis | The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 18 Years | 64 Years | Both | 100 | Phase 4 | Israel |
| 2230 | NCT01276262 (ClinicalTrials.gov) | March 2011 | 12/1/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects | A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects | Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction | Drug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 45 Years | Female | 22 | Phase 1 | United Kingdom |
| 2231 | NCT01317797 (ClinicalTrials.gov) | March 2011 | 18/2/2011 | A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis | A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate | Rheumatoid Arthritis | Drug: namilumab (MT203);Drug: Placebo | Takeda | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | Bulgaria;Netherlands |
| 2232 | NCT01313208 (ClinicalTrials.gov) | March 2011 | 10/3/2011 | Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy | Rheumatoid Arthritis | Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy | Amgen | NULL | Completed | 18 Years | 80 Years | All | 210 | Phase 4 | United States;Canada |
| 2233 | NCT01311622 (ClinicalTrials.gov) | March 2011 | 21/2/2011 | Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects | An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects | Rheumatoid Arthritis;Healthy Subjects | Drug: warfarin;Drug: fostamatinib | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Both | 15 | Phase 1 | United Kingdom |
| 2234 | NCT01232569 (ClinicalTrials.gov) | March 2011 | 1/11/2010 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab 162 mg;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 656 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru |
| 2235 | NCT01299961 (ClinicalTrials.gov) | March 2011 | 18/2/2011 | Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis | Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: abatacept | University of California, Los Angeles | NULL | Completed | 18 Years | N/A | All | 25 | Phase 3 | United States |
| 2236 | NCT01663116 (ClinicalTrials.gov) | March 2011 | 5/8/2011 | Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients | Phase Ib/IIa, Escalating Dose, Single Blind, Clinical Trial to Assess the Safety of the i.v Administration of Allogeneic Adipose-derived Mesenchymal Cells (eASCs) to Refractory Rheumatoid Arthritis (RA) Patients. | Rheumatoid Arthritis Aggravated | Genetic: Stem cells;Genetic: Placebo | Tigenix S.A.U. | NULL | Completed | 18 Years | N/A | All | 53 | Phase 1/Phase 2 |