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

Sponsor
University Hospital, Tours
Study ID
NCT01895764
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
  • Methotrexate — DRUG
    methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26

Study Details

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

Key Dates

Start date
Mar 20, 2013
Status verified
Mar 2026
Primary completion
Apr 27, 2015
Completion
Apr 27, 2015

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab
    adalimumab 40mg every 2 weeks
  • Experimental: Adalimumab + Methotrexate
    adalimumab 40mg every 2 weeks and methotrexate 10mg per week

Primary Outcome Measure

presence or absence of antibodies against adalimumab [ Time Frame: 6 months ]

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