271. Ankylosing spondylitis Clinical trials / Disease details


Clinical trials : 563 Drugs : 372 - (DrugBank : 72) / Drug target genes : 41 - Drug target pathways : 145

  
18 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
2NCT03733925
(ClinicalTrials.gov)
January 7, 20195/11/2018A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisA Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisSpondylitis, Ankylosing;Arthritis, PsoriaticDrug: GolimumabJohnson & Johnson Private LimitedNULLCompleted18 YearsN/AAll100Phase 4India
3NCT02758782
(ClinicalTrials.gov)
September 201620/4/2016NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing SpondylitisCOmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre TrialAnkylosing SpondylitisBiological: Golimumab;Drug: CelecoxibCharite University, Berlin, GermanyNULLCompleted18 YearsN/AAll156Phase 4Germany
4NCT03557853
(ClinicalTrials.gov)
June 20165/6/2018Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With GolimumabA Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)Ankylosing Spondylitis;CoxitisDrug: Golimumab InjectionMSD Pharmaceuticals LLCNULLUnknown status18 YearsN/AAll39Russian Federation
5EUCTR2015-002284-42-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
6EUCTR2014-000241-74-DE
(EUCTR)
30/12/201401/10/2014A Study of Golimumab in Participants with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: golimumab
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti-TNFa monoclonal antibody
Janssen Biologics, BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of
7NCT02186873
(ClinicalTrials.gov)
September 3, 20148/7/2014A Study of Golimumab in Participants With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: GolimumabJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll208Phase 3United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania
8NCT01668004
(ClinicalTrials.gov)
September 3, 20121/8/2012The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012Ankylosing SpondylitisBiological: GolimumabMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll101Phase 4Netherlands
9EUCTR2012-002458-21-NL
(EUCTR)
23/07/201203/07/2012Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with GolimumabOpen-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASY Ankylosing Spondylitis(Bechterew disease)
MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
MERCK SHARP & DOHME B.V.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
10NCT01610947
(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
11NCT01248793
(ClinicalTrials.gov)
October 201024/11/2010Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group)Centocor, Inc.NULLCompleted18 YearsN/AAll213Phase 3China
12NCT01313858
(ClinicalTrials.gov)
April 201010/3/2011A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1613N/AGermany
13NCT01081717
(ClinicalTrials.gov)
April 14, 20094/3/2010Golimumab Safety and Surveillance Program Using the Ingenix NHI DatabaseA Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological TreatmentsRheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing SpondylitisDrug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general populationJanssen Biotech, Inc.NULLCompletedN/A99 YearsAll1064United States
14EUCTR2004-003299-12-GB
(EUCTR)
11/10/200624/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
15EUCTR2004-003299-12-FI
(EUCTR)
26/04/200628/12/2005A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
16EUCTR2004-003299-12-DE
(EUCTR)
04/04/200602/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
17EUCTR2004-003299-12-BE
(EUCTR)
20/03/200601/02/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
18NCT00265083
(ClinicalTrials.gov)
December 200512/12/2005A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: golimumab;Biological: Golimumab (CNTO 148); placeboCentocor, Inc.Schering-PloughCompleted18 YearsN/AAll356Phase 3United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom