271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 563 / 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
| 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 | EUCTR2017-001970-41-DK (EUCTR) | 21/12/2017 | 15/09/2017 | Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial | Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) | Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Humira Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: L04AB05 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Enbrel Product Name: Etanercept Product Code: L04AB01 INN or Proposed INN: ETANERCEPT | MD, PhD Salome Kristensen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Denmark | ||
| 2 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 3 | NCT01934933 (ClinicalTrials.gov) | September 24, 2014 | 17/8/2013 | Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: celebrex;Drug: Enbrel;Drug: Enbrel plus Celebrex | Sun Yat-sen University | NULL | Completed | 18 Years | 65 Years | All | 150 | Phase 4 | China |
| 4 | NCT02202850 (ClinicalTrials.gov) | August 12, 2014 | 23/7/2014 | Defining Remission With Etanercept in AS in Real Life Clinical Practice | Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered)) | Ankylosing Spondylitis | Drug: etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 84 | Belgium | |
| 5 | 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 | ||
| 6 | 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 | |||
| 7 | 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 | |||
| 8 | 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 | |||
| 9 | NCT01411215 (ClinicalTrials.gov) | January 2011 | 13/5/2011 | A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department | A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: Enbrel | Pfizer | NULL | Terminated | 18 Years | N/A | All | 160 | N/A | China |
| 10 | EUCTR2010-020913-10-GB (EUCTR) | 11/08/2010 | 23/07/2010 | An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS | An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS | Ankylosing spondylitis | Trade Name: Enbrel® Product Name: Enbrel INN or Proposed INN: Etanercept Trade Name: Enbrel Product Name: Enbrel | Norfolk & Norwich University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 11 | EUCTR2009-012424-87-GB (EUCTR) | 26/11/2009 | 14/10/2009 | T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF | T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF | Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.0;Classification code 10037160;Term: Psoriatic arthritis MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Humira INN or Proposed INN: adalimumab Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Enbrel INN or Proposed INN: Etanercept | Imperial College London South Kensington London | NULL | Not Recruiting | Female: yes Male: yes | 55 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 12 | EUCTR2009-015515-40-NL (EUCTR) | 20/11/2009 | 28/09/2009 | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS | The diagnosis of Ankylosing Spondylitis (AS) requires radiographically proven sacroiliitis.Inflammation on MRI is a prognostic factor for the development of AS. The aim is the decrease of inflammation on MRI of the SI joint and/or spine by giving them, a short period, anti-TNF therapy. The study is designed as a randomized, double-blind, placebo-controlled trial. After inclusion patients are randomly assigned to the etanercept- or placebo-arm of the study in a 1:1 ratio during 16 weeks. | Trade Name: Enbrel | Wyeth Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Netherlands | |||
| 13 | NCT01421303 (ClinicalTrials.gov) | October 2009 | 19/8/2011 | Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. | Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept | Ankylosing Spondylitis | Drug: Enbrel | Pfizer | NULL | Completed | 18 Years | N/A | All | 80 | Belgium | |
| 14 | EUCTR2007-003096-39-IT (EUCTR) | 29/07/2009 | 27/03/2009 | Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CREST | Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CREST | Ankylosing Spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: Etanercept | WYETH LEDERLE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 15 | NCT01188655 (ClinicalTrials.gov) | May 2008 | 24/8/2010 | Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis | Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Enbrel | Pfizer | NULL | Completed | 18 Years | N/A | All | 89 | N/A | NULL |
| 16 | EUCTR2006-002748-27-HU (EUCTR) | 01/04/2008 | 30/01/2008 | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, severe and advanced axial ankylosing spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 17 | NCT00544557 (ClinicalTrials.gov) | October 2007 | 15/10/2007 | Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis | Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation | Ankylosing Spondylitis | Drug: Etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 1715 | Germany | |
| 18 | EUCTR2006-002748-27-NL (EUCTR) | 13/04/2007 | 20/11/2006 | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, severe and advanced axial ankylosing spondylitis MedDRA version: 8.1;Level: LLT;Classification code 10048811;Term: Bechterew's disease | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 19 | NCT00434044 (ClinicalTrials.gov) | February 2007 | 9/2/2007 | Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis | Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | N/A | Both | 150 | Phase 3 | NULL |
| 20 | EUCTR2006-002748-27-DE (EUCTR) | 15/01/2007 | 15/12/2006 | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, severe and advanced axial ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 21 | NCT00420238 (ClinicalTrials.gov) | January 2007 | 8/1/2007 | Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept (Enbrel);Other: Placebo | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | 70 Years | All | 82 | Phase 4 | France;Germany;Hungary;Netherlands |
| 22 | EUCTR2006-002748-27-FR (EUCTR) | 01/12/2006 | 19/12/2006 | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, severe and advanced axial ankylosing spondylitis. | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;Hungary;Germany;Netherlands | ||
| 23 | NCT00410046 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | Extension Study Evaluating Etanercept in Ankylosing Spondylitis | An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | N/A | All | 84 | Phase 4 | Denmark;Finland;Sweden;United Kingdom |
| 24 | 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 | |||
| 25 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 26 | 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 | |||
| 27 | 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 | |||
| 28 | 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 | |||
| 29 | 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 | |||
| 30 | EUCTR2005-001549-41-IT (EUCTR) | 14/02/2006 | 09/10/2008 | 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 Spondilitis (AS) MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: Etanercept Trade Name: Salazopyrin En-Tabs INN or Proposed INN: Sulfasalazine | WYETH LEDERLE | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | |||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | NCT00195416 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | Study Investigating Enbrel Treatment for Ankylosing Spondylitis | A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | N/A | Both | 526 | Korea, Republic of | |
| 37 | NCT00444340 (ClinicalTrials.gov) | April 2004 | 5/3/2007 | An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis | An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (Etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | N/A | Both | 70 | Phase 4 | NULL |
| 38 | NCT00421915 (ClinicalTrials.gov) | March 2002 | 8/1/2007 | Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis | Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | 70 Years | Both | 84 | Phase 3 | NULL |
| 39 | NCT01289743 (ClinicalTrials.gov) | February 2002 | 1/2/2011 | Etanercept (Enbrel) in Ankylosing Spondylitis | An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Charite University, Berlin, Germany | Rheumazentrum Ruhrgebiet | Active, not recruiting | 18 Years | 65 Years | Both | 24 | Phase 2 | Germany |