RecruitingPhase 3NCT05428488

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.


Sponsor

University Hospital, Montpellier

Enrollment

220 participants

Start Date

Nov 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specific step-up treatment strategy in rheumatoid arthritis — starting with a TNF inhibitor and then switching to a different biologic drug (abatacept) if it does not work — is better than the current standard approach. The goal is to find the most effective sequence of treatments. **You may be eligible if:** - You are at least 18 years old - You have rheumatoid arthritis confirmed by ACR-EULAR 2010 criteria - You test positive for ACPA (a specific antibody associated with RA) - You are currently on methotrexate or leflunomide for at least 3 months but your disease is still active (DAS28-CRP above 3.2) - You have not previously tried biologic or targeted synthetic DMARD treatments - A TNF inhibitor has been recommended for you **You may NOT be eligible if:** - You have contraindications to TNF inhibitors or abatacept - You have untreated active tuberculosis or have not had TB screening in the past 3 months - You are pregnant or breastfeeding - You have fibromyalgia or dementia - You have a drug or alcohol addiction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbatacept (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.

DRUGTNF 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.

DRUGTNF 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

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NCT05428488


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