Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Information source: University Hospital, Tours
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Adalimumab (Drug); Methotrexate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University Hospital, Tours Official(s) and/or principal investigator(s): Emilie DUCOURAU, MD, Principal Investigator, Affiliation: CHRU de TOURS
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.
Clinical Details
Official title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: presence or absence of antibodies against adalimumab
Secondary outcome: Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)Change from baseline of T and B cells concentrations. Change from baseline of "APRIL" and "TNF alpha" concentrations
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rhumatologie, CH de BLOIS, Blois 41000, France
Rhumatologie, CHRU de BREST, Brest 29609, France
Rhumatologie, CHD LA ROCHE SUR YON, La Roche Sur Yon 85925, France
Rhumatologie, CHR du MANS, Le Mans 72037, France
Rhumatologie, CHRU de NANTES, Nantes 44093, France
Rhumatologie / IPROS, CHR d'ORLEANS, Orleans 45032, France
Rhumatologie, CHRU de POITIERS, Poitiers 86021, France
Rhumatologie, CHRU de RENNES, Rennes 35203, France
Rhumatologie, CH de SAINT BRIEUC, Saint Brieuc 22027, France
Médecine polyvalente, CH de SAINT NAZAIRE, Saint Nazaire 44606, France
Rhumatologie, CHRU de TOURS, Tours 37044, France
Additional Information
Starting date: March 2013
Last updated: April 8, 2015
|