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

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.

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