Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis (MESYNAD)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Spondyloarthritis

Treatments

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT04360785

APHP180571

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

Patients aged from 18 to 90
Patients suffering from axial SpA, radiographic or non-radiographic according to ASAS criteria (peripheral involvement and/or Inflammatory bowel diseases could be present).
Indication for anti TNF treatment: resistance to at least 2 NSAIDs and no contraindication to adalimumab
No previous treatment with methotrexate in the last 3 months
Stable dosage of steroids (less than 10mg/day of prednisone equivalent) and/or of NSAIDs for at least 10 days
Contraception feminine or masculine
Informed and written consent
Social insurance

Exclusion criteria :

Contraindication to methotrexate
Previous treatment with adalimumab
Steroids more than 10mg/day of prednisone equivalent
Previous treatment with:
- Etanercept in the last month
- Infliximab, golimumab, certolizumab in the last 2 months (Previous treatment hereafter these dates with anti-TNF except adalimumab or secukinumab are not a counterindication)
Current immunosuppressive drugs except methotrexate
Current and proven pregnancy
Project of pregnancy in the next 3 months following inclusion
Legal safeguards
Inclusion in another interventional research project