TNFR:Fc ( DrugBank: - )
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 | 19 |
| 107 | 若年性特発性関節炎 | 5 |
| 271 | 強直性脊椎炎 | 23 |
46. 悪性関節リウマチ
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 | 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 | NCT00617032 (ClinicalTrials.gov) | February 2004 | 5/2/2008 | Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94 | A Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis | Rheumatoid Arthritis | Genetic: tgAAC94 gene therapy vector;Genetic: tgAAC94 placebo | Targeted Genetics Corporation | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States;Canada |
| 14 | 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 | ||
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 | |||
| 19 | 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 |
107. 若年性特発性関節炎
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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-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 | |||
| 5 | 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 |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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-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 | |||
| 5 | EUCTR2006-001061-42-FI (EUCTR) | 09/01/2007 | 10/07/2006 | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | Ankylosing spondylitis (AS). | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 6 | EUCTR2005-001549-41-GR (EUCTR) | 08/12/2006 | 10/08/2006 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3;Phase 4 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 7 | EUCTR2005-001549-41-CZ (EUCTR) | 28/11/2006 | 17/10/2006 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: ENBREL INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Finland;Hungary;United Kingdom;Germany;Czech Republic;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 8 | EUCTR2006-001061-42-DK (EUCTR) | 03/11/2006 | 15/09/2006 | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | Ankylosing spondylitis (AS). | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 9 | EUCTR2006-002349-35-ES (EUCTR) | 30/09/2006 | 02/08/2006 | Estudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante.A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADET | Estudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante.A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADET | Espondilitis anquilosanteAnkylosing spondylitis | Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001, TNFR:FC | Wyeth Farma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 4 | Spain | ||
| 10 | EUCTR2006-001061-42-SE (EUCTR) | 23/08/2006 | 13/06/2006 | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | Ankylosing spondylitis (AS). | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 11 | EUCTR2006-001061-42-GB (EUCTR) | 31/07/2006 | 11/06/2006 | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) | Ankylosing spondylitis (AS). | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Denmark;United Kingdom;Sweden | ||
| 12 | EUCTR2005-001549-41-PT (EUCTR) | 29/06/2006 | 16/03/2006 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Finland;Hungary;Portugal;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 13 | EUCTR2005-001549-41-DK (EUCTR) | 24/03/2006 | 21/12/2005 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 14 | EUCTR2005-001549-41-SE (EUCTR) | 15/03/2006 | 16/02/2006 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 15 | EUCTR2005-001549-41-FI (EUCTR) | 08/03/2006 | 14/11/2005 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Hungary;Finland;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 16 | EUCTR2005-001549-41-DE (EUCTR) | 15/02/2006 | 28/11/2005 | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 17 | EUCTR2005-001549-41-GB (EUCTR) | 02/02/2006 | 29/11/2005 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 18 | EUCTR2005-001549-41-IE (EUCTR) | 09/01/2006 | 31/03/2006 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 19 | EUCTR2005-001549-41-AT (EUCTR) | 27/12/2005 | 22/11/2005 | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | |||
| 20 | EUCTR2005-001549-41-ES (EUCTR) | 27/12/2005 | 27/10/2005 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3;Phase 4 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 21 | EUCTR2005-001549-41-HU (EUCTR) | 25/11/2005 | 13/10/2005 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3;Phase 4 | Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden;Portugal;Greece;Finland;Spain | ||
| 22 | NCT00126724 (ClinicalTrials.gov) | August 2005 | 2/8/2005 | Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects | A Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects With and Without Concurrent TNF-alpha Antagonists | Arthritis, Rheumatoid;Arthritis, Psoriatic;Ankylosing Spondylitis | Genetic: tgAAC94 gene therapy vector;Genetic: tgAAC94 placebo | Targeted Genetics Corporation | NULL | Completed | 18 Years | 75 Years | Both | 120 | Phase 1/Phase 2 | United States |
| 23 | NCT00000433 (ClinicalTrials.gov) | October 1999 | 18/1/2000 | Blocking Tumor Necrosis Factor in Ankylosing Spondylitis | Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Anti-Tumor Necrosis Factor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | 18 Years | 80 Years | Both | 42 | Phase 2 | United States |