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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 October 2015
Main ID:  NCT01895764
Date of registration: 24/04/2013
Prospective Registration: Yes
Primary sponsor: University Hospital, Tours
Public title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS) COMARIS
Scientific title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Date of first enrolment: March 2013
Target sample size: 110
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01895764
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Emilie DUCOURAU, MD
Address: 
Telephone:
Email:
Affiliation:  CHRU de TOURS
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Drug: Adalimumab
Drug: Methotrexate
Primary Outcome(s)
presence or absence of antibodies against adalimumab [Time Frame: 6 months]
Secondary Outcome(s)
Change from baseline of "APRIL" and "TNF alpha" concentrations [Time Frame: 6 months]
Change from baseline of T and B cells concentrations. [Time Frame: 6 months]
Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) [Time Frame: 6 months]
Secondary ID(s)
2012-004939-23
2012-R41
A130042-32
PHRI12-ED-COMARIS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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