Ankylosing Spondylitis Clinical Trial
— COMARISOfficial title:
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Rhumatologie, CH de BLOIS | Blois | |
France | Rhumatologie, CHRU de BREST | Brest | |
France | Rhumatologie, CHD LA ROCHE SUR YON | La Roche Sur Yon | |
France | Rhumatologie, CHR du MANS | Le Mans | |
France | Rhumatologie, CHRU de NANTES | Nantes | |
France | Rhumatologie / IPROS, CHR d'ORLEANS | Orleans | |
France | Rhumatologie, CHRU de POITIERS | Poitiers | |
France | Rhumatologie, CHRU de RENNES | Rennes | |
France | Rhumatologie, CH de SAINT BRIEUC | Saint Brieuc | |
France | Médecine polyvalente, CH de SAINT NAZAIRE | Saint Nazaire | |
France | Rhumatologie, CHRU de TOURS | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence or absence of antibodies against adalimumab | 6 months | No | |
Secondary | Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 6 months | No | |
Secondary | Change from baseline of T and B cells concentrations. | 6 months | Yes | |
Secondary | Change from baseline of "APRIL" and "TNF alpha" concentrations | 6 months | No |
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