Status:
UNKNOWN
Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders
Lead Sponsor:
Lille Catholic University
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invali...
Detailed Description
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invali...
Eligibility Criteria
Inclusion
- age \>18 years
- RA according to the ACR/EULAR 2010 criteria
- inadequate response to a subcutaneously administered first-line TNFi defined as moderate to high disease activity (DAS28-ESR\>3.2 and CDAI\>10) after at least 3 months of treatment with a TNFi
- beneficiary of the French National Health Insurance Fund
- signed informed consent form
- for women of childbearing age: effective contraception during treatment period with engagement to continue such contraception for 14 weeks after last administration
Exclusion
- counter-indication for one or other of the two drugs under study
- prior failure of the TNFi due to intolerance
- receiving ≥15 mg/day prednisone for more than 4 weeks
- pregnant or nursing women
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03227419
Start Date
January 22 2018
End Date
November 1 2024
Last Update
September 13 2023
Active Locations (26)
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1
Hôpital Saint-Philibert
Lomme, Hauts-de-France, France, 59462
2
Hôpital Avicenne
Bobigny, France
3
CHU de Bordeaux
Bordeaux, France
4
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, France