46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | EUCTR2009-011137-26-PL (EUCTR) | 01/04/2010 | 25/01/2010 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland | ||||
| 2 | EUCTR2009-011137-26-GR (EUCTR) | 22/03/2010 | 20/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 3 | EUCTR2009-011137-26-PT (EUCTR) | 01/03/2010 | 09/12/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | |||
| 4 | EUCTR2009-011137-26-CZ (EUCTR) | 26/02/2010 | 13/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 5 | EUCTR2009-011137-26-AT (EUCTR) | 25/02/2010 | 04/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 6 | EUCTR2009-011137-26-IT (EUCTR) | 15/02/2010 | 02/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE | Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073 | Product Name: Golimumab Product Code: SCH900259 Product Name: Golimumab Product Code: SCH 900259 | Shering Plough Research Institute, A division of Schering Plough Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 7 | EUCTR2009-011137-26-BE (EUCTR) | 18/01/2010 | 19/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 8 | EUCTR2009-011137-26-IE (EUCTR) | 21/12/2009 | 15/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | |||
| 9 | EUCTR2009-011137-26-FR (EUCTR) | 15/12/2009 | 10/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 10 | EUCTR2009-011137-26-DK (EUCTR) | 07/12/2009 | 02/11/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland | ||||
| 11 | EUCTR2009-011137-26-NL (EUCTR) | 02/12/2009 | 31/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 12 | EUCTR2009-011137-26-SK (EUCTR) | 11/11/2009 | 19/11/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 13 | EUCTR2009-011137-26-ES (EUCTR) | 23/10/2009 | 06/08/2009 | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE | Artritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 14 | EUCTR2009-011137-26-FI (EUCTR) | 22/10/2009 | 25/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 15 | EUCTR2009-011137-26-HU (EUCTR) | 19/10/2009 | 02/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 16 | EUCTR2009-011137-26-GB (EUCTR) | 19/10/2009 | 18/10/2010 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 17 | EUCTR2009-011137-26-DE (EUCTR) | 05/10/2009 | 03/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands |