Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosi… (NCT01895764) | Clinical Trial Compass
CompletedPhase 4
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
France110 participantsStarted 2013-03-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
presence or absence of antibodies against adalimumab