drugset / Trial / NCT01895764

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

NCT01895764 ↗

Phase 4 Completed 110 enrolled University Hospital, Tours
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Timeline

Start
2013-03-20
Primary completion
2015-04-27
Completion
2015-04-27

Outcome

Met primary endpoint

paper ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX- group (p=0.03). PMID 31958280 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Methotrexate Small molecule 10 mg Subcutaneous