Ro 48-77533 (DrugBank: -)
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 | 2 |
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 | EUCTR2005-001138-33-IT (EUCTR) | 28/09/2005 | 01/02/2007 | A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis. | A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis. | rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 650 | Portugal;Denmark;Slovenia;Norway;Spain;Italy | |||
2 | EUCTR2005-000884-25-IT (EUCTR) | 02/05/2005 | 22/06/2005 | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. | A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy. | rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*2,5MG 25CPR INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*7,5MG/ML 4SIR. INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*10MG/1,33ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*20MG/2,66ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR INN or Proposed INN: Methotrexate | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 570 | United Kingdom;Germany;Iceland;Italy;Sweden |