Baricitinib Added to Corticosteroids in PMR (Polymyalgia Rheumatica) May Improve Control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized study compares baricitinib at 2 mg or 4 mg daily added to low-dose corticosteroids versus placebo with steroids in adults diagnosed with PMR. Participants must have active PMR with a PMR-AS-CRP score above 17 and limited or tapering steroid use before randomization. The goal is to see if adding baricitinib can improve disease control and allow steroid-sparing while monitoring safety in a population at risk for GC-related complications. The trial is sponsored by University Hospital, Brest, with collaboration from Eli Lilly, and is conducted at multiple French sites. Eligibility includes age 50+, confirmed PMR, and no major comorbidities that would interfere with participation.

Why it matters

Who can join: the full rules

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

Where it's running

• VIDAL François
  Aix-en-Provence, France Recruiting
• LEGRAND Jean-Louis
  Arras, France Recruiting
• Besançon-CIC
  Besançon, France Recruiting
• PRATI Clément
  Besançon, France Recruiting
• Dr Alain SARAUX
  Brest, France Recruiting
• RAT Anne-Christine
  Caen, France Recruiting

Study contacts

• Study coordinator: Alain SARAUX, Pr
• Email: alain.saraux@chu-brest.fr
• Phone: +33298223333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.