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Completed

NCT Number: NCT01895764

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

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

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rhumatologie, CH de BLOIS, Blois, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject 18 years of age or older
  • Able and willing to give written informed consent and to comply with the requirements of the study protocol
  • Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria
  • Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs

Exclusion criteria

  • Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy.
  • Previous methotrexate treatment, not stopped 3 month before inclusion
  • Surgery scheduled during study
  • Female subject without method of contraception
  • Contraindication to adalimumab or methotrexate

Treatment and study plan

Adalimumab

Drug

adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26

Other names: Humira

methotrexate

Drug

methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26

Other names: Metoject

Primary outcomes

  1. presence or absence of antibodies against adalimumab

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 6 months

  2. Change from baseline of T and B cells concentrations.

    Time frame: 6 months

  3. Change from baseline of "APRIL" and "TNF alpha" concentrations

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: COMARIS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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