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New RA strategy: switch drugs after 12 weeks for better control?

NCT ID NCT05428488

Disease control Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a sequential treatment strategy for rheumatoid arthritis (RA). Participants first receive a TNF inhibitor for 12 weeks, then switch to abatacept. The goal is to see if this approach leads to more remissions than staying on TNF inhibitors alone. The study enrolls 220 adults with active RA despite methotrexate or leflunomide.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abatacept and TNF inhibitor
What this could lead to
If successful, this sequential approach could offer a more effective and better-tolerated way to control rheumatoid arthritis, potentially improving remission rates.
What could go wrong
This is a Phase 3 trial, but results may not confirm the hypothesis. The sequential strategy may not outperform standard TNF inhibitor treatment, and some patients may experience side effects from the medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged between 18 or above * Rheumatoid arthritis according to ACR-EULAR 2010 (American College of Rheumatology-European League Against Rheumatism) * ACPA positive * Under methotrexate or leflunomide treatment for at least 3 months * DAS28-CRP\>3.2 under methotrexate or leflunomide calculated with CRP dated less than 7 days from baseline * Escape under synthetic background treatment defined by an elevation of C-reactive protein (CRP) (CRP\> 5mg/L ) or Erythrocyte sedimentation rate (ESR) (for men: \> age in years/2 ; for women: \> age (+10) /2)) within the last 6 months before baseline * Targeted DMARDs (biological and targeted synthetic DMARDs) naïve * Indication for a TNF inhibitor Exclusion Criteria: * Subject unable to read or/and write * Planned longer stay outside the region that prevents compliance with the visit plan * Subject unable to sign informed consent form * Subject not covered by public health insurance * Dementia * Fibromyalgia * Contra-indications to TNF inhibitor and/or Abatacept * Absence of tuberculosis screening in the previous 3 months before baseline * Patient with untreated active tuberculosis * Patient who cannot be followed during 48 weeks * Drug addiction, addiction to alcohol * Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent). * Women of child bearing potential, unless they are using an effective method of birth control * Patient under law protection * Prisoners * Subject who are in a dependency or employment with the sponsor or the investigator * Participation in another interventional clinical trial or administration of an investigational product within the last 4 weeks before the screening date * Subject with moderate to severe heart failure (class 3 or class 4 cardiac disease as defined by the New York Heart Association Functional Classification) * Patients had a history of chronic obstructive pulmonary disease (COPD) and heavy smoking * Patients had a planned surgical procedure at least 30 days before the screening day * Known allergy or intolerance to an anti-TNF therapy * Hypersensitivity to the Abatacept or to any of its excipients * Patient with untreated active hepatitis B * Patient vaccinated with a live vaccine within 30 days prior to screening * Patients with an Inflammatory Bowel Disease (IBD) (loss of chance if switching from an anti-TNF to abatacept)

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Bicêtre

    NOT_YET_RECRUITING

    Paris, France

  • APHP Cochin

    RECRUITING

    Paris, France

  • APHP La Pitié Salpetrière

    RECRUITING

    Paris, France

  • CH du Mans

    RECRUITING

    Le Mans, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHR Orléans Nouvel hôpital d'Orléans

    RECRUITING

    Orléans, France

  • CHU Bordeaux groupe Pellegrin

    RECRUITING

    Bordeaux, France

  • CHU de Brest La Cavale Blanche

    RECRUITING

    Brest, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • CHU de Nice

    RECRUITING

    Nice, France

  • CHU de Nîmes Carémeau

    NOT_YET_RECRUITING

    Nîmes, France

  • CHU de Strasbourg Hautepierre

    NOT_YET_RECRUITING

    Strasbourg, France

  • CHU de Tours - Hopital Trousseau

    RECRUITING

    Tours, France

  • Centre Hospitalier Universitaire de Montpellier

    RECRUITING

    Montpellier, France, 34295, France

  • Centre Hospitalier de Cahors

    NOT_YET_RECRUITING

    Cahors, France

  • Centre hospitalier Princesse Grace

    RECRUITING

    Monaco, Monaco

  • Chu Purpan

    NOT_YET_RECRUITING

    Toulouse, France

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