107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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 | EUCTR2009-011593-15-NL (EUCTR) | 09/02/2010 | 30/09/2009 | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 2 | EUCTR2009-011593-15-FR (EUCTR) | 12/11/2009 | 04/12/2009 | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis | polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 3 | EUCTR2009-011593-15-BE (EUCTR) | 19/10/2009 | 23/09/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 3 | Canada;Argentina;Belgium;Poland;Brazil;Peru;Australia;Netherlands;Germany;Mexico;United States;Spain;Russian Federation;Italy;United Kingdom;France | ||
| 4 | EUCTR2009-011593-15-DE (EUCTR) | 08/09/2009 | 20/07/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;Peru;Germany;Netherlands | |||
| 5 | EUCTR2009-011593-15-GB (EUCTR) | 20/08/2009 | 06/07/2009 | A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints | A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic 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: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 185 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany |