NCT04343378Completed
Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
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 arthritis patients
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 9 Jan 2020
- Start date
- 8 Jun 2020
- Primary completion date
- 13 Nov 2024
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04343378
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 8 Jun 2020 to the primary completion date, 13 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- RA negative for ACPA (anti-citrullinated proteins antibodies) or not fulfilling ACR/EULAR criteria
Age
- Age \< 18 years
Other
- Abatacept discontinuation due to serious adverse event, loss of efficacy or pregnancy project
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.