Last reviewed · How we verify
NCT01895764: COMARIS
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Phase 4 trial testing Adalimumab in Ankylosing Spondylitis in 110 participants. Completed in 27 April 2015.
27 April 2015
Quick facts
| Lead sponsor | University Hospital, Tours |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 20 March 2013 |
| Primary completion | 27 April 2015 |
| Estimated completion | 27 April 2015 |
| Sites | 11 locations across France |
Drugs / interventions tested
- Adalimumab (ADALIMUMAB) — full drug profile →
- Methotrexate — full drug profile →
Conditions studied
- Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →
Sponsor
University Hospital, Tours
Who can join
18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial.
Ducourau E, Rispens T, Samain M, Dernis E, et al · · 2020 · cited 39× · PMID 31958280 · DOI 10.1136/rmdopen-2019-001047 -
The Risk of Adverse Effects of TNF-α Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis.
He B, Li Y, Luo WW, Cheng X, et al · · 2022 · cited 21× · PMID 35250992 · DOI 10.3389/fimmu.2022.814429
Verify or expand the search:
- PubMed search for NCT01895764
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Adalimumab
Trials testing the same drug.
- NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
- NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
- NCT07268534 — Biologics in Folliculitis Decalvans : an Adaptative Trial Research · Phase 2 · not yet recruiting
- NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
- NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
Other recruiting trials for Ankylosing Spondylitis
Currently open trials in the same condition.
- NCT07510789 — Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis · recruiting
- NCT07261644 — A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS) · Phase 3 · recruiting
- NCT07390929 — Clinical Trial Study on the Improved New Method of Acupotomy for AS · NA · recruiting
- NCT06905288 — Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea. · recruiting
- NCT07166874 — The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis · NA · recruiting
Other University Hospital, Tours trials
Trials by the same sponsor.
- NCT07452978 — Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence · Phase 2 · not yet recruiting
- NCT07443800 — Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia · NA · not yet recruiting
- NCT07251530 — Communication Enhancement Among Ventilated Patients in Intensive Care · not yet recruiting
- NCT07189338 — Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation · NA · not yet recruiting
- NCT07054112 — Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01895764 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Tours
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01895764.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing