Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis
- Registration Number
- NCT04360785
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methotrexate + Adalimumab Methotrexate Experimental group : patients will receive 2 subcutaneous injections of methotrexate in addition of the usual adalimumab
- Primary Outcome Measures
Name Time Method serum concentrations of ADAb anti adalimumab 6 month To assess if 2 subcutaneous injections of methotrexate could prevent anti adalimumab antibodies formation at month 6 in patients with spondyloarthritis
- Secondary Outcome Measures
Name Time Method Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using ASDAS (Ankylosing Spondylitis Disease Activity Score) score. At 3, 6 and 12 months 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)
serum concentrations of ADAb anti adalimumab At 1, 3 and 12 months To compare the percentage of immunized patients at month 1, 3 and 12 in the 2 groups
residual serum concentration of adalimumab At 1, 3, 6 and 12 months To compare trough levels of adalimumab at month 1, 3, 6 and 12 in the 2 groups.
Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score. At 3, 6 and 12 months 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)
Comparison of Adalimumab Therapeutic efficacity in term of therapeutic maintenance At 3, 6 and 12 months Assess by Number of patient who didn't switch treatment
Incidence of Treatment-Emergent Adverse Events At 1, 3, 6 and 12 months 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
Comparison of Adalimumab Therapeutic efficacity in term of nonsteroidal anti inflammatory drugs ' reduction At 3, 6 and 12 months Assess by ASAS-NSAIDS score (Assessment of SpondyloArthritis international Society - nonsteroidal antiinflammatory drugs) (minimum 0. a higher score means a worse outcome)
Trial Locations
- Locations (17)
CH Pontoise
🇫🇷Pontoise, France
CHR Orléans
🇫🇷Orléans, France
Hopital Pellegrin
🇫🇷Bordeaux, France
Hopital Mondor
🇫🇷Créteil, France
CH Le Mans
🇫🇷Le Mans, France
Hopital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
Hopital Bichat
🇫🇷Paris, France
CHU Trousseau
🇫🇷Chambray-lès-Tours, France
Kremlin Bicetre hospital
🇫🇷Le Kremlin-Bicêtre, France
Hopital Saint Philibert
🇫🇷Lille, France
CHU Rouen
🇫🇷Rouen, France
Hopital la Pitié Salpétrière
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital La Cavale Blanche
🇫🇷Brest, France
CH Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU Nantes
🇫🇷Nantes, France
Hopital Cochin
🇫🇷Paris, France