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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT01895764 |
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Date of registration:
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24/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
COMARIS |
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Scientific title:
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Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS) |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01895764 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Emilie DUCOURAU, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHRU de TOURS |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Methotrexate
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Drug: Adalimumab
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Primary Outcome(s)
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presence or absence of antibodies against adalimumab
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change from baseline of "APRIL" and "TNF alpha" concentrations
[Time Frame: 6 months]
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Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
[Time Frame: 6 months]
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Change from baseline of T and B cells concentrations.
[Time Frame: 6 months]
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Secondary ID(s)
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2012-004939-23
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2012-R41
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A130042-32
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PHRI12-ED-COMARIS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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