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Study of baricitinib versus placebo for treating polymyalgia rheumatica in adult patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Polymyalgia Rheumatica (PMR), a condition that causes muscle pain and stiffness, particularly in the shoulders and hips. The study will test a medication called baricitinib (also known as Olumiant), which will be given as film-coated tablets. The purpose is to determine if baricitinib combined with a short course of glucocorticoids (a type of steroid medication) works better than placebo with glucocorticoids in treating PMR.

The study will use different doses of baricitinib (2 mg and 4 mg tablets) or matching placebo tablets. Participants will take the medication orally once daily. The main treatment period will last 24 weeks, during which patients will receive either baricitinib or placebo along with a short course of glucocorticoids. The study will monitor how well the treatment controls disease activity when patients are no longer taking glucocorticoids.

Throughout the study, healthcare providers will regularly check participants' disease activity using various measurements to determine how well the treatment is working. The trial will evaluate whether patients can achieve good disease control without needing to continue steroid medication after receiving the study treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive either Olumiant (baricitinib) tablets or placebo tablets that look identical

    The dosage will be either 4 mg or 2 mg tablets taken by mouth

    This treatment will be combined with a short course of glucocorticoids (GCs), which are anti-inflammatory medications

  2. Step 2

    12-week assessment

    Your disease activity will be measured using a special score called PMR-AS-CRP

    The goal is to achieve a score of 10 or lower without needing glucocorticoids

    Your response to treatment will be evaluated

  3. Step 3

    24-week assessment

    This is the main evaluation point of the study

    Your disease activity will be measured again using the PMR-AS-CRP score

    The target is to maintain a score of 10 or lower without using glucocorticoids

    Your overall response to treatment will be assessed

  4. Step 4

    36-week assessment

    Final evaluation of your disease activity using the PMR-AS-CRP score

    The goal remains to maintain a score of 10 or lower without glucocorticoids

    Long-term response to treatment will be evaluated

Who can join the trial?

7 criteria

  • You must be at least 50 years old
  • You must have been diagnosed with Polymyalgia Rheumatica (PMR), either newly diagnosed or resistant to previous treatments
  • You must either not be taking glucocorticoids (GCs) or taking less than 15 mg per day for at least 15 days before the study starts (glucocorticoids are steroid medications like prednisone used to reduce inflammation)
  • Your PMR disease activity score (PMR-AS-CRP) must be higher than 17, which indicates active disease
  • You must not have any other inflammatory joint conditions, connective tissue diseases, or blood vessel inflammation (vasculitis)
  • You must be able to understand and sign the informed consent form
  • You must have French health insurance

Who cannot join the trial?

15 criteria

  • Age below 50 years or above 85 years
  • Current diagnosis or history of giant cell arteritis (inflammation of blood vessels in the head and neck)
  • Previous treatment with disease-modifying antirheumatic drugs (medications that suppress the immune system) for PMR
  • Active or recent serious infections, including tuberculosis
  • History of blood clots or high risk of developing blood clots
  • Significant kidney or liver problems
  • Uncontrolled diabetes (high blood sugar levels)
  • Current or recent cancer diagnosis
  • Pregnancy or breastfeeding
  • Major surgery planned during the study period
  • Participation in other clinical trials within the past 30 days
  • Severe heart disease or uncontrolled high blood pressure
  • History of severe allergic reactions to similar medications
  • Current use of medications that could interact with the study drug
  • Conditions that could interfere with study assessments or patient safety
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Investigated drugs

  • Baricitinib

    is a medication that helps reduce inflammation in the body. It belongs to a class of drugs called JAK inhibitors, which work by decreasing the activity of the immune system. In this trial, it's being studied for treating polymyalgia rheumatica, a condition that causes muscle pain and stiffness.

  • Prednisone

    and Prednisolone are corticosteroid medications (also known as GCs or glucocorticoids) that help reduce inflammation and suppress the immune system. These medications are commonly used to treat various inflammatory conditions, including polymyalgia rheumatica. In this trial, they are being used as a short-term treatment alongside either baricitinib or placebo.

What is already known about the treatment

  • Baricitinib

    An oral medication belonging to the class of Janus kinase (JAK) inhibitors, taken as tablets once daily. It works by blocking specific enzymes involved in inflammation, helping to reduce symptoms in inflammatory conditions like Polymyalgia Rheumatica (PMR). This medication is being studied in clinical trials as a potential treatment to reduce reliance on glucocorticoids (GCs) in PMR patients, aiming to achieve better disease control while minimizing steroid use. Baricitinib is already approved for treating other inflammatory conditions like rheumatoid arthritis, showing promising results in managing inflammatory diseases.

  • Prednisone

    An oral glucocorticoid medication that belongs to the corticosteroid class, typically taken as tablets according to a prescribed schedule. It works by suppressing the immune system and reducing inflammation throughout the body, making it effective for treating various inflammatory conditions including Polymyalgia Rheumatica. This synthetic steroid hormone has been a standard treatment for inflammatory conditions for many decades, though medical professionals often aim to minimize its long-term use due to potential side effects.

  • Prednisolone

    An oral glucocorticoid medication very similar to prednisone, taken as tablets and belonging to the corticosteroid class of drugs. It is the active form of prednisone in the body and works by reducing inflammation and suppressing immune system activity. This medication is widely used in treating inflammatory conditions like Polymyalgia Rheumatica, though healthcare providers typically aim to use the lowest effective dose for the shortest necessary duration due to potential side effects from long-term use.

Investigated diseases

Polymyalgia Rheumatica (PMR) - A chronic inflammatory condition that causes muscle pain and stiffness, primarily affecting the shoulders, neck, and hips. The condition typically develops gradually over several weeks and is characterized by morning stiffness that may last for hours. People with PMR often experience pain and limited range of motion in their upper arms, shoulders, neck, hips, and thighs. The condition most commonly affects people over the age of 50, and women are more likely to develop it than men. The symptoms tend to be worse in the morning or after periods of inactivity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518385-26-01Protocol code29BRC23.0160Estimated enrolment140 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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