Ro487-7533/f10-04 (DrugBank: -)
2 diseases| 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 | 2 |
| 51 | 全身性強皮症 | 3 |
| 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 | 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 | ||
| 2 | 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 |
| 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 | EUCTR2015-000424-28-HR (EUCTR) | 18/12/2015 | 01/02/2016 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | Portugal;United States;Greece;Spain;Lithuania;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Japan | ||
| 2 | EUCTR2015-000424-28-DE (EUCTR) | 02/11/2015 | 27/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 3 | EUCTR2015-000424-28-PT (EUCTR) | 31/07/2015 | 30/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan |