Status:
COMPLETED
Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Rouen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to identify a panel of immunological molecular and cellular biomarkers able to predict the success of major dose-reduction or discontinuation of abatacept in rheumatoid ...
Detailed Description
Parameters studied at different time points (before initiation of abatacept if sample is available in our biocollection; prior to dose tapering; prior to discontinuation) ACPA (anti-citrullinated prot...
Eligibility Criteria
Inclusion
- Rheumatoid arthritis (RA) patients (\> pr = 18 years) fulfilling the 2010 ACR/EULAR criteria
- Associated to high levels (\> 3 x upper limit of normal in UA/ml) of ACPA measured by the usual anti-CCP(cyclic citrullinated proteins)2 test at the start of abatacept treatment
- Receiving IV (intravenous) or SC (subcutaneous) abatacept alone or in combination with a conventional Disease Modyfying AntiRheumatic Drugs (cDMARD) (methotrexate, leflunomide, sulfasalasin in monotherapy or in combination) according to the usual scheme or in tapering phase
- Without intra-articular injections of corticosteroids during the last 6 months prior to down-titration of abatacept
- Having discontinued corticosteroids at he time of entrance in the study
- In deep remission (Disease Activity Score (DAS) 28 ESR (or CRP) \< 2.6 without clinical synovitis) since at least 1 year
- In sonographic remission at the time of enrollment (absence of PD (Power Doppler)-positive synovitis on 28 joints defined by a score \< 2 on a 0-3 semi-quantitative scale for each joint)
Exclusion
- Age \< 18 years
- RA negative for ACPA (anti-citrullinated proteins antibodies) or not fulfilling ACR/EULAR criteria
- Abatacept discontinuation due to serious adverse event, loss of efficacy or pregnancy project
Key Trial Info
Start Date :
June 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04343378
Start Date
June 8 2020
End Date
November 14 2024
Last Update
March 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rouen University Hospital
Rouen, France