271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05527444 (ClinicalTrials.gov) | March 15, 2022 | 6/5/2022 | The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients | The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients | Ankylosing Spondylitis | Drug: Secukinumab 150 mg/ml;Drug: Adalimumab Ab;Drug: NSAID;Drug: Thalidomide Pill | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 65 Years | All | 100 | Phase 4 | China |
| 2 | NCT04885751 (ClinicalTrials.gov) | June 1, 2021 | 26/4/2021 | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy | Drug: Eupatilin;Drug: Rebamipide | Seoul National University Boramae Hospital | Dong-A ST Co., Ltd. | Not yet recruiting | 19 Years | 70 Years | All | 50 | Phase 4 | NULL |
| 3 | ChiCTR2100043171 | 2021-02-08 | 2021-02-07 | Efficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real world | Efficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real world | Axial spinal arthritis/ankylosing spondylitis | test group:Iguratimod; | Qilu Hospital of Shandong University | NULL | Recruiting | Male | test group:278; | Phase 4 | China | ||
| 4 | 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 |
| 5 | EUCTR2016-000615-33-DE (EUCTR) | 29/07/2016 | 06/07/2016 | 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 (CONSUL) | 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 (CONSUL) - CONSUL | ankylosing spondylitis (AS) MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10048398;Term: Spondylitis ankylosing aggravated;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi Trade Name: Celebrex | Charite Universitaetsmedizin | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 4 | Germany | ||
| 6 | NCT02763046 (ClinicalTrials.gov) | May 31, 2016 | 3/5/2016 | Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM) | Ankylosing Spondylitis | Drug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 211 | Phase 4 | Germany |
| 7 | EUCTR2015-004575-74-DE (EUCTR) | 16/03/2016 | 18/02/2016 | Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitis | A randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUM | Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany | ||
| 8 | NCT02469753 (ClinicalTrials.gov) | October 23, 2015 | 9/6/2015 | Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes | Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes | Ankylosing Spondylitis | Drug: NSAIDs;Drug: anti-TNF | University Hospital, Bordeaux | NULL | Active, not recruiting | 18 Years | N/A | All | 188 | Phase 3 | France;Monaco |
| 9 | NCT02293681 (ClinicalTrials.gov) | April 10, 2015 | 14/11/2014 | An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement | A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement | Spondylitis, Ankylosing | Drug: Infliximab;Drug: NSAIDs;Drug: DMARDs | Janssen Research & Development, LLC | NULL | Terminated | 16 Years | 40 Years | All | 76 | N/A | China |
| 10 | NCT04345458 (ClinicalTrials.gov) | March 6, 2014 | 3/4/2020 | Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis | Safety 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 Trial | Ankylosing Spondylitis | Drug: prefilled liquid etanercept(Yisaipu);Drug: lyophilized etanercept powder(Yisaipu) | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | NULL | Completed | 18 Years | 65 Years | All | 640 | Phase 3 | China |
| 11 | NCT01209702 (ClinicalTrials.gov) | September 2010 | 24/9/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs | A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs | Spondylitis, Ankylosing | Biological: tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 306 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands |
| 12 | NCT01091675 (ClinicalTrials.gov) | September 2010 | 22/3/2010 | Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to =2 NSAIDs | Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to =2 Nonsteroidal Antiinflammatory Drug (NSAID) | Ankylosing Spondylitis | Drug: Etoricoxib | Spanish Foundation of Rheumatology | NULL | Completed | 18 Years | N/A | All | 58 | Phase 3 | Spain |
| 13 | NCT02456363 (ClinicalTrials.gov) | November 2009 | 14/12/2014 | Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis | Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis—A Registry Project | Ankylosing Spondylitis | Biological: TNF alpha;Drug: NSAIDs and sulfasalazine | Chung Shan Medical University | NULL | Recruiting | 18 Years | N/A | Both | 300 | Phase 2 | Taiwan |
| 14 | NCT01077843 (ClinicalTrials.gov) | August 17, 2009 | 26/2/2010 | Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163) | A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany | Ankylosing Spondylitis | Drug: Etoricoxib;Drug: Other Cox-2 inhibitors;Drug: Other Non-selective NSAIDs;Other: No anti-inflammatory treatment | Organon and Co | NULL | Completed | N/A | N/A | All | 27381 | NULL | |
| 15 | EUCTR2007-007637-39-DE (EUCTR) | 17/12/2008 | 15/04/2008 | Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADAS | Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADAS | Ankylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms. MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Voltaren resinat Product Name: Voltaren resinat Product Code: not applicable | Charité - Campus Mitte | NULL | Not Recruiting | Female: yes Male: yes | 174 | Phase 4 | Germany | ||
| 16 | NCT00715091 (ClinicalTrials.gov) | September 2008 | 14/7/2008 | Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis | Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial | Ankylosing Spondylitis | Drug: diclophenac | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 65 Years | Both | 180 | Phase 4 | Germany |
| 17 | NCT00576706 (ClinicalTrials.gov) | December 2007 | 17/12/2007 | PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity | A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis | Drug: Rebamipide;Drug: Misoprostol | Korea Otsuka Pharmaceutical Co.,Ltd. | NULL | Completed | 19 Years | N/A | Both | 396 | Phase 3 | Korea, Republic of |
| 18 | EUCTR2006-002306-64-DE (EUCTR) | 28/12/2006 | 04/10/2006 | Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01 | Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01 | Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors | Trade Name: Rituximab/ Mabthera Product Name: MabThera Product Code: Ro45-2294 INN or Proposed INN: rituximab | Charité Universitaetsmedizin | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 19 | NCT00367211 (ClinicalTrials.gov) | September 2006 | 18/8/2006 | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) | POZEN | NULL | Completed | 18 Years | N/A | Both | 400 | Phase 3 | United States |