An interventional study of Methotrexate in Spondyloarthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 17 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
Preliminary report have demonstrated that methotrexate induces an anti bio-medicament tolerization whan administrated just before the first administration of the bio-medicament. Once this tolerization is obtained it seems useless to continue the methotrexate because this treatment has no efficacity in cases of spondyloarthritis.
spondyloarthritis are treated in first intention by NSAIDs but in case of inefficacity biotherapies that inhib the TNF are used. Adalimumab is the most used anti TNF in this indication. Monoclonal antibody uses in therapy is immunogene, and there is a clear link between increase of anti drug antibody and in one hand decrease of drug serum concentration and in an other failure of the therapeutic response. With adalimumab there is an apparition of ADAb in 30%. There are reports suggesting that adding methotrexate to the therapy in a specific timeline allow to prevent the immunization. A previous study shows that association in long terms between methotrexate and adalimumab induce less immunized patients. The investigator's goal is to assess if two methotrexate subcutaneous injections at day 1 and 2 could prevent anti adalimumab antibodies formation.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 124 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion criteria :
Previous treatment with:
Experimental group : patients will receive 2 subcutaneous injections of methotrexate in addition of the usual adalimumab
Drug: Methotrexate
Reference group : patient will receive adalimumab as usual to treat spondyloarthritis
Patients randomized in this arm will have one subcutaneous injection of methotrexate 15min before and one 24h after their first injection of adalimumab prescribed as usual
serum concentrations of ADAb anti adalimumab
To assess if 2 subcutaneous injections of methotrexate could prevent anti adalimumab antibodies formation at month 6 in patients with spondyloarthritis
Time frame: 6 month
residual serum concentration of adalimumab
To compare trough levels of adalimumab at month 1, 3, 6 and 12 in the 2 groups.
Time frame: At 1, 3, 6 and 12 months
serum concentrations of ADAb anti adalimumab
To compare the percentage of immunized patients at month 1, 3 and 12 in the 2 groups
Time frame: At 1, 3 and 12 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by the number of AE and SAE related to the treatment that occur during the participation of the patient
Time frame: At 1, 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using ASDAS (Ankylosing Spondylitis Disease Activity Score) score.
A therapeutic efficacity will be described as a clinical pertinent change of ASDAS : Ankylosing Spondylitis Disease Activity Score (at least 1,1 point) (a higher score means a worse outcome)
Time frame: At 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score.
A therapeutic efficacity will be described as a clinical pertinent change of BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (0 to 50 points - a higher score means a worse outcome)
Time frame: At 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of therapeutic maintenance
Assess by Number of patient who didn't switch treatment
Time frame: At 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of nonsteroidal anti inflammatory drugs ' reduction
Assess by ASAS-NSAIDS score (Assessment of SpondyloArthritis international Society - nonsteroidal antiinflammatory drugs) (minimum 0. a higher score means a worse outcome)
Time frame: At 3, 6 and 12 months
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris