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RECRUITING
NCT05428488
PHASE3

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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