CsDMARDs
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 75 |
46. 悪性関節リウマチ
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
Showing 1 to 10 of 75 trials
| 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 | NCT05165771 (ClinicalTrials.gov) | July 202220220700 | 8/12/202120211208 | 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 Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumato ... | 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 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evalu ... | Rheumatoid Arthritis | Drug: GS-5718;Drug: Placebo to match GS-5718;Drug: Tofacitinib 5 mg;Drug: Placebo to match Tofacitinib Drug: GS-5718;Drug: Placebo to match GS-5718;Drug: Tofacitinib 5 mg;Drug: Placebo to match Tofacitin ... | Gilead Sciences | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 2 | NCT05424393 (ClinicalTrials.gov) | March 4, 202220220304 | 15/6/202220220615 | 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 Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etaner ... | 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 | |
| 3 | ChiCTR2100048699 | 2021-05-2520210525 | 2021-07-1220210712 | 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 A multicentre, randomized, parallel-controlled clinical study of the efficacy and safety of Iguratim ... | Clinical cohort study of organ injury and repair in severe rheumatic diseases---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 | |
| 4 | JPRN-jRCTs071200107 | 25/05/202120210525 | 03/03/202120210303 | 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 ... | 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 ... | 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. In patients with active RA for whom continuous MTX treatment (including other concurrent csDMARDs) f ... | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 400 | N/A | Japan |
| 5 | ChiCTR2200055876 | 2020-12-0120201201 | 2022-01-2220220122 | 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 ... | 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 ... | 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 |
| 6 | JPRN-jRCTs041200048 | 02/10/202020201002 | 02/10/202020201002 | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Art ... | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Art ... | Rheumatoid arthritis | 1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued 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) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment 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. - Restoring, 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. 1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. ... | Asai Shuji | Kojima Toshihisa | Recruiting | >= 20age old | Not applicable | Both | 114 | N/A | Japan |
| 7 | NCT04333771 (ClinicalTrials.gov) | July 31, 202020200731 | 2/4/202020200402 | 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. A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the E ... | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | China |
| 8 | JPRN-jRCT1041190125 | 09/03/202020200309 | 09/03/202020200309 | 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 Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoi ... | 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. 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from week ... | Asai Shuji | NULL | Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 9 | NCT03970837 (ClinicalTrials.gov) | June 5, 201920190605 | 16/5/201920190516 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to ... | 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 A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3 ... | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDs Biological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Pla ... | GlaxoSmithKline | Iqvia Pty Ltd | Terminated | 18 Years | N/A | All | 1764 | Phase 3 | United States;Argentina;Australia;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom;Brazil United States;Argentina;Australia;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea ... |
| 10 | EUCTR2016-000933-37-BG (EUCTR) | 09/05/201820180509 | 12/01/201820180112 | 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) Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of C ... | 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) A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in ... | 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] Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classificatio ... | 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 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive na ... | 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 Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombi ... |