Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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