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

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Methotrexate

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