271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details


臨床試験数 : 563 薬物数 : 374 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145

  
69 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05164198
(ClinicalTrials.gov)
January 15, 20228/11/2021Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease ActivityMulticenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease ActivityAnkylosing Spondylitis;Axial SpondyloarthritisBiological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilarHanyang University Seoul HospitalLinical KoreaNot yet recruiting18 Years65 YearsAll448Phase 4NULL
2NCT04507763
(ClinicalTrials.gov)
August 1, 202027/7/2020Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing SpondylitisClinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With EtanerceptAnkylosing SpondylitisDrug: EtanerceptPfizerNULLCompleted18 YearsN/AAll1Iraq
3NCT04077957
(ClinicalTrials.gov)
October 7, 20191/9/2019Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDsTreat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled StudyAnkylosing Spondylitis;SpondyloarthritisDrug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Etanercept (50mg per week, for 4 weeks);Drug: Etanercept (50mg per week, for 2 weeks);Drug: Etanercept (50mg per week)Nanfang Hospital of Southern Medical UniversityNULLNot yet recruiting18 Years50 YearsAll100Phase 4China
4ChiCTR1900025749
2019-09-202019-09-07Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled StudyTreat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study Ankylosing SpondylitisExperimental:conventional synthetic Disease modifying anti-rheumatic drugs(csDMARDs);Experimental:Etanercept (Anbainuo 50mg per week, for 4 weeks);Experimental:Etanercept (Anbainuo 50mg per week, for 2 weeks);Positive Control:Etanercept (Anbainuo 50mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 50mg per 10 days, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per 2 weeks, for 12 weeks);Nanfang Hospital of Southern Medical UniversityNULLPending1850BothExperimental:50;Experimental:50;Experimental:50;Positive Control:50;Positive Control:50;Positive Control:50;Positive Control:50;N/AChina
5EUCTR2017-001970-41-DK
(EUCTR)
21/12/201715/09/2017 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 KristensenNULLAuthorised-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): yesDenmark
6NCT02809781
(ClinicalTrials.gov)
June 201616/6/2016A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing SpondylitisPhase III Study of Human Bone Marrow-Derived Mesenchymal Stem Cells to Treat ASSpondylitis;Spondylitis, Ankylosing;Ankylosis;Arthritis;Spondylarthritis;Spondylarthropathies;Spinal Diseases;Musculoskeletal Diseases;Bone DiseasesBiological: Intravenous infusion of MSCs;Drug: EtanerceptSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNanfang Hospital of Southern Medical University;Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting18 Years45 YearsBoth250Phase 2/Phase 3China
7NCT02638896
(ClinicalTrials.gov)
January 201620/12/2015Dose Reduction of Etanercept in Patients With Ankylosing SpondylitisEfficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept (Half-Dose);Drug: etanercept (Full-Dose);Drug: Sulfasalazine;Drug: CelecoxibZhixiang HuangNULLNot yet recruiting18 Years45 YearsBoth100Phase 4NULL
8EUCTR2015-002284-42-FI
(EUCTR)
18/09/201528/08/2015The 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 activitINTENT: 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 specifyTrade 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
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
9NCT01934933
(ClinicalTrials.gov)
September 24, 201417/8/2013Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisA Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: celebrex;Drug: Enbrel;Drug: Enbrel plus CelebrexSun Yat-sen UniversityNULLCompleted18 Years65 YearsAll150Phase 4China
10NCT02202850
(ClinicalTrials.gov)
August 12, 201423/7/2014Defining Remission With Etanercept in AS in Real Life Clinical PracticeDefining 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 SpondylitisDrug: etanerceptPfizerNULLCompleted18 YearsN/AAll84Belgium
11NCT04582084
(ClinicalTrials.gov)
April 4, 20143/10/2020Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune ArthritisAssessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance StudyRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: EtanerceptAryoGen Pharmed Co.NULLCompleted18 YearsN/AAll583Iran, Islamic Republic of
12NCT04345458
(ClinicalTrials.gov)
March 6, 20143/4/2020Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing SpondylitisSafety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III TrialAnkylosing SpondylitisDrug: prefilled liquid etanercept(Yisaipu);Drug: lyophilized etanercept powder(Yisaipu)Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.NULLCompleted18 Years65 YearsAll640Phase 3China
13EUCTR2012-005026-30-HU
(EUCTR)
15/08/201320/02/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
498Phase 3Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
14NCT02132234
(ClinicalTrials.gov)
June 201328/4/2014Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisEffects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;HypertensionDrug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: InfliximabJagiellonian UniversityDepartmet of Rheumatology, J Dietl Hospital, Krakow, PolandRecruiting18 YearsN/ABoth100Phase 4Poland
15EUCTR2012-005026-30-PL
(EUCTR)
17/05/201308/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
16EUCTR2012-005026-30-CZ
(EUCTR)
15/05/201322/02/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
17EUCTR2012-005026-30-BG
(EUCTR)
10/04/201305/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
18NCT01610947
(ClinicalTrials.gov)
May 14, 201224/5/2012Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease ActivityEffect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled TrialSpondyloarthritisDrug: Adalimumab, Etanercept, Golimumab or infliximabUniversity Hospital, MontpellierNULLCompleted18 YearsN/AAll398N/AFrance
19NCT03880968
(ClinicalTrials.gov)
March 1, 201212/3/2019Treat-to-Target Strategy With Etanercept for Ankylosing SpondylitisTreat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or DiscontinuationSpondylitis, AnkylosingDrug: tapering or discontinuation of etanerceptSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine;First Affiliated Hospital of Wenzhou Medical University;The First Hospital of Jiaxing;Shaoxing Second Hospital;Shanghai Jiao Tong University Affiliated Sixth People's Hospital;Ningbo Medical Center Lihuili Hospital;Wenzhou Central Hospital;Zhejiang Provincial People's Hospital;Shaoxing People's HospitalCompleted18 Years65 YearsAll311NULL
20NCT01411215
(ClinicalTrials.gov)
January 201113/5/2011A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient DepartmentA Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology DepartmentRheumatoid Arthritis;Ankylosing SpondylitisDrug: EnbrelPfizerNULLTerminated18 YearsN/AAll160N/AChina
21NCT01793285
(ClinicalTrials.gov)
December 201030/1/2013An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical TrialRetrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)Ankylosing SpondylitisDrug: ETANERCEPTPfizerNULLCompleted18 YearsN/AAll85N/ASpain
22EUCTR2010-020913-10-GB
(EUCTR)
11/08/201023/07/2010An 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 - ANSWERSAn 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 spondylitisTrade Name: Enbrel®
Product Name: Enbrel
INN or Proposed INN: Etanercept
Trade Name: Enbrel
Product Name: Enbrel
Norfolk & Norwich University Hospitals NHS Foundation TrustNULLNot 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): yesUnited Kingdom
23NCT01060098
(ClinicalTrials.gov)
April 201029/1/2010T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNULLCompleted18 Years80 YearsAll48United Kingdom
24EUCTR2009-012424-87-GB
(EUCTR)
26/11/200914/10/2009T 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 TNFT 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 LondonNULLNot 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): yesUnited Kingdom
25EUCTR2009-015515-40-NL
(EUCTR)
20/11/200928/09/2009PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVASPREVENTION 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: EnbrelWyeth Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Netherlands
26NCT01421303
(ClinicalTrials.gov)
October 200919/8/2011Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With EtanerceptAnkylosing SpondylitisDrug: EnbrelPfizerNULLCompleted18 YearsN/AAll80Belgium
27EUCTR2007-003096-39-IT
(EUCTR)
29/07/200927/03/2009Effects 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 - CRESTEffects 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 LEDERLENULLNot RecruitingFemale: yes
Male: yes
Italy
28NCT00910273
(ClinicalTrials.gov)
July 200927/5/2009Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis PatientsEffects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active ASAnkylosing SpondylitisDrug: etanerceptPfizerLincoln Medical and Mental Health CenterTerminated18 YearsN/AAll34Phase 4Italy
29NCT02489760
(ClinicalTrials.gov)
July 200827/6/2015Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyEtanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyAnkylosing SpondylitisBiological: Adalimumab;Biological: EtanerceptChung Shan Medical UniversityNULLActive, not recruiting18 Years70 YearsBoth30Phase 4Taiwan
30NCT01188655
(ClinicalTrials.gov)
May 200824/8/2010Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing SpondylitisObservational Non-Interventional Study With Enbrel in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: EnbrelPfizerNULLCompleted18 YearsN/AAll89N/ANULL
31EUCTR2006-002748-27-HU
(EUCTR)
01/04/200830/01/2008A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
32NCT01072058
(ClinicalTrials.gov)
February 200818/2/2010Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerProspective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerArthritis, Rheumatoid;Spondylitis, AnkylosingDrug: TNF blockers (infliximab, adalimumab, etanercept)University of Sao PauloNULLActive, not recruiting18 Years70 YearsBoth100Phase 4Brazil
33NCT00544557
(ClinicalTrials.gov)
October 200715/10/2007Study Evaluating The Use Of Etanercept In Patients With Ankylosing SpondylitisObservational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic EvaluationAnkylosing SpondylitisDrug: EtanerceptPfizerNULLCompleted18 YearsN/AAll1715Germany
34NCT02915354
(ClinicalTrials.gov)
July 200723/9/2016Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up StudyRelapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Three Years' Following-up StudySpondylitis, Ankylosing;RecurrenceDrug: EtanerceptSun Yat-sen UniversityNULLCompleted18 YearsN/ABoth35Phase 4China
35EUCTR2006-002748-27-NL
(EUCTR)
13/04/200720/11/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
36NCT00434044
(ClinicalTrials.gov)
February 20079/2/2007Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisMulticenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth150Phase 3NULL
37EUCTR2006-002748-27-DE
(EUCTR)
15/01/200715/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA 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 spondylitisTrade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
38EUCTR2006-001061-42-FI
(EUCTR)
09/01/200710/07/2006An 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
39NCT00420238
(ClinicalTrials.gov)
January 20078/1/2007Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing SpondylitisAnkylosing SpondylitisDrug: Etanercept (Enbrel);Other: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll82Phase 4France;Germany;Hungary;Netherlands
40EUCTR2005-001549-41-GR
(EUCTR)
08/12/200610/08/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Phase 3;Phase 4Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
41EUCTR2006-002748-27-FR
(EUCTR)
01/12/200619/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;Hungary;Germany;Netherlands
42NCT00410046
(ClinicalTrials.gov)
December 20068/12/2006Extension Study Evaluating Etanercept in Ankylosing SpondylitisAn Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll84Phase 4Denmark;Finland;Sweden;United Kingdom
43NCT00873730
(ClinicalTrials.gov)
December 20061/4/2009Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in SpainA 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: etanercept/placeboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll108Phase 4NULL
44EUCTR2005-001549-41-CZ
(EUCTR)
28/11/200617/10/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
525Portugal;Finland;Hungary;United Kingdom;Germany;Czech Republic;Denmark;Ireland;Spain;Italy;Greece;Sweden
45EUCTR2006-001061-42-DK
(EUCTR)
03/11/200615/09/2006An 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
46EUCTR2006-002349-35-ES
(EUCTR)
30/09/200602/08/2006Estudio 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. - LOADETEstudio 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 spondylitisTrade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001, TNFR:FC
Wyeth Farma S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
47EUCTR2006-001061-42-SE
(EUCTR)
23/08/200613/06/2006An 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
48NCT00458185
(ClinicalTrials.gov)
August 20065/4/2007Study Evaluating Etanercept in Patients With Ankylosing SpondylitisMulticentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth40Phase 4NULL
49EUCTR2006-001061-42-GB
(EUCTR)
31/07/200611/06/2006An 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 DivisionNULLNot 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): yesFinland;Denmark;United Kingdom;Sweden
50EUCTR2005-001549-41-PT
(EUCTR)
29/06/200616/03/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
525Finland;Hungary;Portugal;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
51EUCTR2005-001549-41-DK
(EUCTR)
24/03/200621/12/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
52EUCTR2005-001549-41-SE
(EUCTR)
15/03/200616/02/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
53EUCTR2005-001549-41-FI
(EUCTR)
08/03/200614/11/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Hungary;Finland;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
54EUCTR2005-001549-41-DE
(EUCTR)
15/02/200628/11/2005A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
55EUCTR2005-001549-41-IT
(EUCTR)
14/02/200609/10/2008A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 LEDERLENULLNot RecruitingFemale: yes
Male: yes
525Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
56EUCTR2005-001549-41-GB
(EUCTR)
02/02/200629/11/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot 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): yesPortugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
57EUCTR2005-001549-41-IE
(EUCTR)
09/01/200631/03/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
540Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
58EUCTR2005-001549-41-ES
(EUCTR)
27/12/200527/10/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
525Phase 3;Phase 4Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
59EUCTR2005-001549-41-AT
(EUCTR)
27/12/200522/11/2005A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA 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 IncNULLNot RecruitingFemale: yes
Male: yes
525Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
60NCT00247962
(ClinicalTrials.gov)
December 200531/10/2005Study Evaluating Etanercept and Sulphasalazine in Ankylosing SpondylitisA Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: sulphasalazine (SSZ)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll566Phase 4Australia;Austria;China;Czech Republic;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Poland;Qatar;Saudi Arabia;Spain;Sweden;United Kingdom;Greece;Portugal;Switzerland
61EUCTR2005-001549-41-HU
(EUCTR)
25/11/200513/10/2005A 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 IncNULLNot RecruitingFemale: yes
Male: yes
525Phase 3;Phase 4Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden;Portugal;Greece;Finland;Spain
62NCT00195416
(ClinicalTrials.gov)
June 200512/9/2005Study Investigating Enbrel Treatment for Ankylosing SpondylitisA Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth526Korea, Republic of
63NCT00133315
(ClinicalTrials.gov)
September 200422/8/2005TNFalfa Blocking Treatment of SpondylarthropathiesTNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With SpondylarthropathiesSpondylarthropathies;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Infliximab;Drug: Etanercept;Drug: AdalimumabHvidovre University HospitalNULLCompleted18 YearsN/ABoth50Phase 4Denmark
64NCT00418548
(ClinicalTrials.gov)
June 20044/1/2007Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth350Phase 3NULL
65NCT00444340
(ClinicalTrials.gov)
April 20045/3/2007An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing SpondylitisAn Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (Etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth70Phase 4NULL
66NCT00421980
(ClinicalTrials.gov)
June 20028/1/2007An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAn Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years66 YearsBoth84Phase 3Belgium
67NCT00356356
(ClinicalTrials.gov)
April 200224/7/200616.0040 Ankylosing Spondylitis StudyOpen-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037Ankylosing SpondylitisDrug: EtanerceptAmgenImmunex CorporationCompleted18 YearsN/ABoth257Phase 3United States
68NCT00421915
(ClinicalTrials.gov)
March 20028/1/2007Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisMulticenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final DataAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth84Phase 3NULL
69NCT01289743
(ClinicalTrials.gov)
February 20021/2/2011Etanercept (Enbrel) in Ankylosing SpondylitisAn Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptCharite University, Berlin, GermanyRheumazentrum RuhrgebietActive, not recruiting18 Years65 YearsBoth24Phase 2Germany