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 | NCT05164198 (ClinicalTrials.gov) | January 15, 2022 | 8/11/2021 | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Ankylosing Spondylitis;Axial Spondyloarthritis | Biological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilar | Hanyang University Seoul Hospital | Linical Korea | Not yet recruiting | 18 Years | 65 Years | All | 448 | Phase 4 | NULL |
| 2 | NCT03733925 (ClinicalTrials.gov) | January 7, 2019 | 5/11/2018 | A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis | A 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 Arthritis | Spondylitis, Ankylosing;Arthritis, Psoriatic | Drug: Golimumab | Johnson & Johnson Private Limited | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | India |
| 3 | NCT02758782 (ClinicalTrials.gov) | September 2016 | 20/4/2016 | NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis | COmparison 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 Trial | Ankylosing Spondylitis | Biological: Golimumab;Drug: Celecoxib | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | All | 156 | Phase 4 | Germany |
| 4 | NCT03557853 (ClinicalTrials.gov) | June 2016 | 5/6/2018 | Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab | A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab) | Ankylosing Spondylitis;Coxitis | Drug: Golimumab Injection | MSD Pharmaceuticals LLC | NULL | Unknown status | 18 Years | N/A | All | 39 | Russian Federation | |
| 5 | 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 | ||
| 6 | EUCTR2014-000241-74-DE (EUCTR) | 30/12/2014 | 01/10/2014 | A Study of Golimumab in Participants with Active Ankylosing Spondylitis | A 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, BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of | ||
| 7 | NCT02186873 (ClinicalTrials.gov) | September 3, 2014 | 8/7/2014 | A Study of Golimumab in Participants With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania |
| 8 | NCT01668004 (ClinicalTrials.gov) | September 3, 2012 | 1/8/2012 | The 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-8259-012 | Ankylosing Spondylitis | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 101 | Phase 4 | Netherlands |
| 9 | EUCTR2012-002458-21-NL (EUCTR) | 23/07/2012 | 03/07/2012 | Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | ||
| 10 | NCT01610947 (ClinicalTrials.gov) | May 14, 2012 | 24/5/2012 | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial | Spondyloarthritis | Drug: Adalimumab, Etanercept, Golimumab or infliximab | University Hospital, Montpellier | NULL | Completed | 18 Years | N/A | All | 398 | N/A | France |
| 11 | NCT01248793 (ClinicalTrials.gov) | October 2010 | 24/11/2010 | Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group) | Centocor, Inc. | NULL | Completed | 18 Years | N/A | All | 213 | Phase 3 | China |
| 12 | NCT01313858 (ClinicalTrials.gov) | April 2010 | 10/3/2011 | A 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 Spondylitis | Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing | Drug: Simponi®;Drug: Methotrexate | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 1613 | N/A | Germany |
| 13 | NCT01081717 (ClinicalTrials.gov) | April 14, 2009 | 4/3/2010 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A 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 Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | NULL | Completed | N/A | 99 Years | All | 1064 | United States | |
| 14 | EUCTR2004-003299-12-GB (EUCTR) | 11/10/2006 | 24/01/2006 | A 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 | A 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 BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 15 | EUCTR2004-003299-12-FI (EUCTR) | 26/04/2006 | 28/12/2005 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 16 | EUCTR2004-003299-12-DE (EUCTR) | 04/04/2006 | 02/01/2006 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 17 | EUCTR2004-003299-12-BE (EUCTR) | 20/03/2006 | 01/02/2006 | A 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 | A 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 BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 18 | NCT00265083 (ClinicalTrials.gov) | December 2005 | 12/12/2005 | A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: golimumab;Biological: Golimumab (CNTO 148); placebo | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 356 | Phase 3 | United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom |