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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Adalimumab; Methotrexate; Vaccines

Criteria

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