84. サルコイドーシス Sarcoidosis Clinical trials / Disease details
臨床試験数 : 149 / 薬物数 : 227 - (DrugBank : 81) / 標的遺伝子数 : 82 - 標的パスウェイ数 : 167
| 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 | EUCTR2009-010714-30-IT (EUCTR) | 18/01/2010 | 11/12/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis - ND | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486 | Product Name: Ustekinumab Product Code: CNTO1275 Product Name: Golimumab Product Code: CNTO148 | CENTOCOR | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Italy | |||
| 2 | EUCTR2009-010714-30-NL (EUCTR) | 22/12/2009 | 03/02/2011 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis - | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Italy | |||
| 3 | EUCTR2009-010714-30-FR (EUCTR) | 10/11/2009 | 15/10/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | NCT00955279 (ClinicalTrials.gov) | November 2009 | 6/8/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis | Sarcoidosis | Drug: Placebo;Drug: Golimumab;Drug: Ustekinumab | Centocor, Inc. | NULL | Completed | 18 Years | 85 Years | All | 173 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Norway;Romania;United Kingdom;Sweden |
| 5 | EUCTR2009-010714-30-DE (EUCTR) | 23/10/2009 | 08/07/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2009-010714-30-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 14.0;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Belgium;Romania;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2009-010714-30-BE (EUCTR) | 28/09/2009 | 08/07/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 13.1;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: Human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Belgium;Denmark;Germany;Norway;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2009-010714-30-GB (EUCTR) | 14/09/2009 | 20/07/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | 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 | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom |