5mg (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 50 | 皮膚筋炎／多発性筋炎 | 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 | ChiCTR-TRC-13003178 | 2013-05-01 | 2013-01-03 | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Polymyositis/Dermatomyositis | group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.; | Department of rheumatology, China-Japan Friendship hospital | NULL | Recruiting | 18 | 70 | Both | group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94; | China | |
| 2 | EUCTR2007-004410-13-SE (EUCTR) | 06/08/2008 | 18/06/2008 | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | active polymyositis, dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis | Trade Name: Methotrexate Wyeth 2,5mg Product Name: Methotrexate Wyeth 2,5mg tbl. INN or Proposed INN: metotrexat Trade Name: Prednisolon Pfizer Product Name: prednisolon INN or Proposed INN: prednisolon Trade Name: Metoject 10 mg/ml Product Name: metotrexat INN or Proposed INN: metotrexat | Institute od Rheumatology Prague | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;Sweden | |||
| 3 | EUCTR2007-004410-13-CZ (EUCTR) | 12/03/2008 | 25/10/2007 | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | active polymyositis, dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis | Trade Name: Methotrexat Lachema 2,5mg Product Name: Methotrexat Lachema 2,5mg tbl. Product Code: 44/154/85-C INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate Trade Name: Prednison 5, 20 Léciva por. tablet nob. Product Name: Prednison 5, 20 Léciva por. tablet nob. Product Code: 56/104/75-C INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob Trade Name: Methotrexat Lachema 5 inj. sol Product Name: Methotrexate Lachema 5inj. sol Product Code: 44/196/81-C INN or Proposed INN: methotrexate Trade Name: Solu-medrol inj. PSO LQF 40mg Product Name: Solu-medrol inj. PSO lqf 40mg INN or Proposed INN: methylprednisoloni natrii succinas | Institute od Rheumatology Prague | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;Sweden |