Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05428488

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Led by University Hospital, Montpellier · Updated on 2025-10-03

220

Participants Needed

17

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosis of rheumatoid arthritis according to ACR-EULAR 2010 criteria
  • Positive for ACPA antibodies
  • Receiving methotrexate or leflunomide treatment for at least 3 months
  • Disease Activity Score (DAS28-CRP) greater than 3.2 with CRP measured within 7 days before baseline
  • Evidence of inflammation shown by elevated CRP (>5 mg/L) or ESR within 6 months before baseline
  • No prior treatment with biological or targeted synthetic DMARDs
  • Eligible for treatment with a TNF inhibitor
Not Eligible

You will not qualify if you...

  • Unable to read or write
  • Planning a long stay away from the study region preventing visit compliance
  • Unable to provide informed consent
  • Not covered by public health insurance
  • Diagnosis of dementia or fibromyalgia
  • Contraindications to TNF inhibitors or abatacept
  • No tuberculosis screening within 3 months before baseline
  • Untreated active tuberculosis
  • Unable to be followed for 48 weeks
  • Drug or alcohol addiction
  • Protected populations such as pregnant or breastfeeding women, prisoners, or individuals under legal guardianship
  • Women of childbearing potential not using effective contraception
  • Under legal protection or prisoners
  • Employment or dependency relationship with the sponsor or investigator
  • Participation in another clinical trial or investigational product use within 4 weeks before screening
  • Moderate to severe heart failure (NYHA class 3 or 4)
  • History of chronic obstructive pulmonary disease or heavy smoking
  • Scheduled surgery within 30 days before screening
  • Known allergy or intolerance to anti-TNF therapy
  • Hypersensitivity to abatacept or its components
  • Untreated active hepatitis B
  • Receipt of live vaccine within 30 days before screening
  • Inflammatory Bowel Disease (IBD)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Centre Hospitalier Universitaire de Montpellier

Montpellier, France, France, 34295

Actively Recruiting

2

CHU Bordeaux groupe Pellegrin

Bordeaux, France

Actively Recruiting

3

CHU de Brest La Cavale Blanche

Brest, France

Actively Recruiting

4

Centre Hospitalier de Cahors

Cahors, France

Not Yet Recruiting

5

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

6

CH du Mans

Le Mans, France

Actively Recruiting

7

CHU de Nantes

Nantes, France

Actively Recruiting

8

CHU de Nice

Nice, France

Actively Recruiting

9

CHU de Nîmes Carémeau

Nîmes, France

Not Yet Recruiting

10

CHR Orléans Nouvel hôpital d'Orléans

Orléans, France

Actively Recruiting

11

APHP Bicêtre

Paris, France

Not Yet Recruiting

12

APHP Cochin

Paris, France

Actively Recruiting

13

APHP La Pitié Salpetrière

Paris, France

Actively Recruiting

14

CHU de Strasbourg Hautepierre

Strasbourg, France

Not Yet Recruiting

15

Chu Purpan

Toulouse, France

Not Yet Recruiting

16

CHU de Tours - Hopital Trousseau

Tours, France

Actively Recruiting

17

Centre hospitalier Princesse Grace

Monaco, Monaco

Actively Recruiting

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Research Team

J

Jacques MOREL, MD-PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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