Status:
COMPLETED
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Lead Sponsor:
University Hospital, Tours
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2015
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01895764
Start Date
March 20 2013
End Date
April 27 2015
Last Update
December 22 2025
Active Locations (11)
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1
Rhumatologie, CH de BLOIS
Blois, France, 41000
2
Rhumatologie, CHRU de BREST
Brest, France, 29609
3
Rhumatologie, CHD LA ROCHE SUR YON
La Roche-sur-Yon, France, 85925
4
Rhumatologie, CHR du MANS
Le Mans, France, 72037