Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
NCT ID: NCT01895764
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2013-03-20
2015-04-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adalimumab
adalimumab 40mg every 2 weeks
Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Adalimumab + Methotrexate
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Interventions
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Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 methotrexate treatment, not stopped 3 month before inclusion
* Surgery scheduled during study
* Female subject without method of contraception
* Contraindication to adalimumab or methotrexate
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Emilie DUCOURAU, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU de TOURS
Locations
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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
Orléans, , 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, , France
Countries
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References
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Ducourau E, Rispens T, Samain M, Dernis E, Le Guilchard F, Andras L, Perdriger A, Lespessailles E, Martin A, Cormier G, Armingeat T, Devauchelle-Pensec V, Gervais E, Le Goff B, de Vries A, Piver E, Paintaud G, Desvignes C, Ternant D, Watier H, Goupille P, Mulleman D. Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. RMD Open. 2020 Jan;6(1):e001047. doi: 10.1136/rmdopen-2019-001047. Epub 2020 Jan 9.
Other Identifiers
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2012-004939-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A130042-32
Identifier Type: OTHER
Identifier Source: secondary_id
2012-R41
Identifier Type: OTHER
Identifier Source: secondary_id
PHRI12-ED-COMARIS
Identifier Type: -
Identifier Source: org_study_id