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New drug could help patients with painful muscle disease ditch steroids

NCT ID NCT03632187

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether abatacept, a drug that calms the immune system, can control polymyalgia rheumatica (a painful inflammatory condition) without the need for long-term steroids. Thirty-four adults with early disease received either abatacept or a placebo for 12 weeks. The goal was to see if more patients could achieve low disease activity without steroids. The study is complete, and results will show if abatacept is a safer alternative to standard steroid treatment.

What this could mean

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

Active substance
Abatacept (a drug that calms the immune system)
What this could lead to
If it works, this could offer a way to control polymyalgia rheumatica with less reliance on steroids, reducing side effects.
What could go wrong
This is a small, early-phase trial with only 34 participants. The drug may not work better than placebo, and side effects are possible.

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

34 people

The number who actually took part.

Started

Dec 2018

Finished

Jun 2022

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

50 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: * Age older than 50 years * Fulfilling ACR/EULAR criteria * Disease duration≤6 months * No steroid since 2 weeks prior randomization * PMR-AS≥ 17 * Absence of signs or symptoms of other musculoskeletal or connective tissue conditions * Able to give informed consent * Concomitant treatments with methotrexate or hydroxychloroquine are not permitted. Exclusion Criteria: * Clinical symptoms of giant cell arteritis * Uncontrolled high blood pressure or cardiovascular disease * Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR * Planned surgical procedure or medical history, blood abnormalities or any clinical condition that compromises inclusion * History of malignant neoplasm within the last 5 years. * Current active infection not controlled * Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol

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Conditions

The condition(s) this trial relates to.

polymyalgia rheumatica

As listed by the trial registrant

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

Polymyalgia rheumatica

Contacts and locations

Locations

  • CH Le Mans

    Le Mans, France

  • CH St-Malo

    St-Malo, France

  • CH de Morlaix

    Morlaix, France

  • CHRU de Brest

    Brest, France, 29609, France

  • CHU Strasbourg

    Strasbourg, France

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