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Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis
Sponsor: University Hospital, Montpellier
Summary
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered. Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial). Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues. Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for 12 weeks with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.
Official title: Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2022-11-28
Completion Date
2027-11
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Abatacept (W12-W48)
The experimental strategy will evaluate abatacept 125 mg/week following 12 weeks of anti-TNF prescribed in usual care. Concomitant treatment with stable doses of csDMARD, non-steroidal anti-inflammatory drugs, analgesic agents, glucocorticoids (≤10 mg of prednisone or the equivalent per day), or a combination of these drugs will be permitted. Patients will continue to take methotrexate or leflunomide for the duration of the study.
TNF Inhibitor (W12-W48)
In the control group, the 88 randomized RA patients will be treated with TNF inhibitor subcutaneous for 36 weeks. In case of insufficient response to a first TNF inhibitor at 24 or 36 weeks, a second TNF inhibitor will be proposed.
TNF Inhibitor (W0-W12)
All included patients will receive TNF inhibitors subcutaneous for 12 weeks.
Locations (17)
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, France
CHU Bordeaux groupe Pellegrin
Bordeaux, France
CHU de Brest La Cavale Blanche
Brest, France
Centre Hospitalier de Cahors
Cahors, France
CHD Vendée
La Roche-sur-Yon, France
CH du Mans
Le Mans, France
CHU de Nantes
Nantes, France
CHU de Nice
Nice, France
CHU de Nîmes Carémeau
Nîmes, France
CHR Orléans Nouvel hôpital d'Orléans
Orléans, France
APHP Bicêtre
Paris, France
APHP Cochin
Paris, France
APHP La Pitié Salpetrière
Paris, France
CHU de Strasbourg Hautepierre
Strasbourg, France
Chu Purpan
Toulouse, France
CHU de Tours - Hopital Trousseau
Tours, France
Centre hospitalier Princesse Grace
Monaco, Monaco