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New drug combo aims to cut steroid use in painful rheumatic condition

NCT ID NCT07279688

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether adding baricitinib (a JAK inhibitor pill) to standard steroid treatment can help people with polymyalgia rheumatica achieve disease control without needing long-term steroids. About 140 adults aged 50+ with active PMR will receive baricitinib (2 mg or 4 mg) or a placebo for 6 months, alongside tapering steroids. The main goal is to see if more patients can maintain low disease activity without steroids at 24 weeks.

What this could mean

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

Active substance
Baricitinib (a JAK inhibitor drug taken as a tablet)
What this could lead to
If successful, this could offer a steroid-sparing treatment option for polymyalgia rheumatica, reducing long-term steroid side effects.
What could go wrong
This is a Phase 3 trial, but baricitinib carries risks of serious infections, heart problems, and cancer. The benefit over steroids is not yet proven.

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 140 people

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

Started

Dec 2025

Expected to finish

Jun 2029

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

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: * At least 50 years of age. * Fulfilling ACR/EULAR classification criteria for PMR newly diagnosed or treatment resistant. * No GCs or GCs \<15 mg/day since at least 15 days prior to planned randomization. * PMR-AS-CRP \>17. * Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis. * Able to give informed consent. * French health insurance holder Exclusion Criteria: * Clinical evidence of giant cell arteritis. * Uncontrolled high blood pressure or cardiovascular disease. * High risk of VTE because of a history of VTE (DVT and/or PE) within 12 weeks prior to randomization or a history of recurrent (\>1) VTE (counting co-occurring DVT+PE as 1 single event). * Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR * Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion. * Current smoker if age \>65 years. * Current active uncontrolled infection. * Treatment by probenecid. * Alkaline phosphatase (ALP) ≥2 x ULN. * Total bilirubin level (TBL) ≥1.5 x ULN. * Neutropenia (absolute neutrophil count \<1000 cells/uL) (\<1.00 x 103/uL or \<1.00 GI/L). * Lymphopenia (lymphocyte count \<500 cells/uL) (\<0.50 x 103/uL or \<0.50 GI/L). * Patient under court protection or protected adults

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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 (PMR)

How to take part

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

  1. The places running it

    23 sites. 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

  • AL TABAA Omar

    NOT_YET_RECRUITING

    Pontoise, France

  • APHP - Kremlin-Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Besançon-CIC

    RECRUITING

    Besançon, 25000, France

  • CARVAJAL ALEGRIA Guillermo

    RECRUITING

    Tours, France

  • CHU Reims

    RECRUITING

    Reims, France

  • CHU de Bordeaux Pellegrin

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

  • CHU de Nice

    RECRUITING

    Nice, 06000, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • DIREZ Guillaume

    RECRUITING

    Le Mans, France

  • Dr Alain SARAUX

    RECRUITING

    Brest, France

  • FAUTREL Bruno - AP-HP La Pitié-Salpétrière

    NOT_YET_RECRUITING

    Paris, France

  • FLIPO René-Marc

    RECRUITING

    Lille, France

  • GOTTENBERG Jacques-Eric

    RECRUITING

    Strasbourg, France

  • LE HENAFF Catherine

    RECRUITING

    Morlaix, France

  • LEGRAND Jean-Louis

    RECRUITING

    Arras, France

  • LESKE Charles

    RECRUITING

    Cholet, France

  • OTTAVIANI Sébastien - AP-HP Bichat

    RECRUITING

    Paris, France

  • PRATI Clément

    RECRUITING

    Besançon, France

  • RAMON André

    RECRUITING

    Dijon, France

  • RAT Anne-Christine

    RECRUITING

    Caen, France

  • TOURNADRE Anne

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • VIDAL François

    RECRUITING

    Aix-en-Provence, France

  • WIRTH Théo

    RECRUITING

    Marseille, France

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