Status:
COMPLETED
Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spondyloarthritis
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
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 ant...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04360785
Start Date
November 11 2020
End Date
February 27 2023
Last Update
October 4 2023
Active Locations (17)
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1
Hopital Pellegrin
Bordeaux, France
2
Hopital Ambroise Paré
Boulogne-Billancourt, France
3
Hopital La Cavale Blanche
Brest, France
4
CHU Trousseau
Chambray-lès-Tours, France