46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | EUCTR2012-005026-30-HU (EUCTR) | 15/08/2013 | 20/02/2013 | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||
| 2 | EUCTR2012-005026-30-PL (EUCTR) | 17/05/2013 | 08/03/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 3 | EUCTR2012-005026-30-CZ (EUCTR) | 15/05/2013 | 22/02/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 4 | EUCTR2012-005026-30-LT (EUCTR) | 10/05/2013 | 21/02/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 5 | EUCTR2012-005026-30-BG (EUCTR) | 10/04/2013 | 05/03/2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 6 | EUCTR2004-000563-96-FI (EUCTR) | 08/03/2005 | 11/10/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Hungary;Finland;Denmark;Norway;Ireland;Spain;Italy;Sweden | |||
| 7 | EUCTR2004-000563-96-AT (EUCTR) | 19/01/2005 | 15/12/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden | |||
| 8 | EUCTR2004-000563-96-ES (EUCTR) | 22/12/2004 | 26/10/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden | |||
| 9 | EUCTR2004-000563-96-IE (EUCTR) | 26/11/2004 | 29/01/2007 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Trade Name: Enbrel Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Spain;Ireland;Italy;Sweden | |||
| 10 | EUCTR2004-000563-96-DK (EUCTR) | 23/11/2004 | 28/08/2007 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden | |||
| 11 | EUCTR2004-000563-96-SE (EUCTR) | 17/11/2004 | 15/09/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden | |||
| 12 | EUCTR2004-000563-96-HU (EUCTR) | 12/11/2004 | 13/09/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden | |||
| 13 | NCT00012506 (ClinicalTrials.gov) | October 1999 | 10/3/2001 | The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis | Uveitis;Arthritis, Juvenile Rheumatoid | Drug: TNFR:Fc | National Eye Institute (NEI) | NULL | Recruiting | 2 Years | 18 Years | Both | Phase 3 | United States | ||
| 14 | NCT00356590 (ClinicalTrials.gov) | December 1998 | 24/7/2006 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012 | Rheumatoid Arthritis | Biological: Etanercept | Amgen | Immunex Corporation | Completed | 18 Years | N/A | All | 468 | Phase 3 | Canada;United States |
| 15 | NCT03780959 (ClinicalTrials.gov) | May 1, 1997 | 18/12/2018 | Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA) | Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis | Drug: Etanercept;Drug: Placebo | Amgen | NULL | Completed | 4 Years | 18 Years | All | 69 | Phase 2/Phase 3 | NULL |
| 16 | NCT00357903 (ClinicalTrials.gov) | April 1997 | 26/7/2006 | Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials | Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials | Rheumatoid Arthritis | Biological: Etanercept | Amgen | Immunex Corporation | Completed | 4 Years | N/A | All | 639 | Phase 3 | Canada;United States |
| 17 | EUCTR2004-000563-96-NO (EUCTR) | 06/10/2004 | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET | Rheumatoid Arthritis | Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate | Wyeth Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 4 | Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden | |||
| 18 | EUCTR2012-001145-40-Outside-EU/EEA (EUCTR) | 07/03/2012 | Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis | Open-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials | Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT | Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320 | NULL | NA | Female: yes Male: yes | 783 | Canada;United States |