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NCT01895764: COMARIS

Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Completed Phase 4 Last updated 3 April 2026
What this trial tests

Phase 4 trial testing Adalimumab in Ankylosing Spondylitis in 110 participants. Completed in 27 April 2015.

Timeline
20 March 2013
Primary endpoint
27 April 2015
27 April 2015

Quick facts

Lead sponsorUniversity Hospital, Tours
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment110
Start date20 March 2013
Primary completion27 April 2015
Estimated completion27 April 2015
Sites11 locations across France

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other trials of Adalimumab

Trials testing the same drug.

Other recruiting trials for Ankylosing Spondylitis

Currently open trials in the same condition.

Other University Hospital, Tours trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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