Ankylosing Spondylitis
Conditions
Keywords
ankylosing spondylitis
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.
Interventions
DRUGAdalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
DRUGMethotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| presence or absence of antibodies against adalimumab | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 6 months |
| Change from baseline of T and B cells concentrations. | 6 months |
| Change from baseline of "APRIL" and "TNF alpha" concentrations | 6 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREmilie DUCOURAU, MD
CHRU de TOURS
Outcome results
None listed