Tru-015 (DrugBank: TRU-015)
3 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 | 7 |
49 | 全身性エリテマトーデス | 1 |
222 | 一次性ネフローゼ症候群 | 1 |
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 |
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1 | EUCTR2007-006150-25-DE (EUCTR) | 09/01/2009 | 26/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria | |||
2 | EUCTR2007-006150-25-AT (EUCTR) | 03/12/2008 | 07/10/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
3 | EUCTR2007-006150-25-NL (EUCTR) | 01/12/2008 | 02/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
4 | EUCTR2007-006150-25-BE (EUCTR) | 05/09/2008 | 24/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;Hungary;Belgium;Austria;Netherlands;Germany | ||
5 | EUCTR2007-006150-25-HU (EUCTR) | 04/07/2008 | 01/04/2009 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany | |||
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 |
6 | EUCTR2007-006150-25-FR (EUCTR) | 24/06/2008 | 05/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
7 | NCT00634933 (ClinicalTrials.gov) | March 2008 | 5/3/2008 | Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate | Arthritis, Rheumatoid | Drug: TRU-015;Drug: Methylprednisolone;Drug: Prednisone | Pfizer | Trubion Pharmaceuticals/Emergent BioSolutions Inc. | Terminated | 18 Years | N/A | All | 222 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Mexico;Netherlands;Romania;Serbia;Austria |
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 | NCT00479622 (ClinicalTrials.gov) | August 2007 | 25/5/2007 | Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: TRU-015 | Wyeth is now a wholly owned subsidiary of Pfizer | Emergent Product Development Seattle LLC | Terminated | 18 Years | 70 Years | Both | 20 | Phase 1 | United States |
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 | NCT00479622 (ClinicalTrials.gov) | August 2007 | 25/5/2007 | Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: TRU-015 | Wyeth is now a wholly owned subsidiary of Pfizer | Emergent Product Development Seattle LLC | Terminated | 18 Years | 70 Years | Both | 20 | Phase 1 | United States |