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

3 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
Centre Hospitalier Pays de Morlaix Morlaix France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier De Cholet Cholet France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Of Bordeaux Talence France
Cafcnw Himpmzlspvo Uzukygqtfmlee Rzzmk Reims France
Ceioon Hrspvzlmuzd Dwbswrlwhqpny Arras France
Cignme Hoztaykpjlh Uhlixuyunbmqd Dt Dbksv Dijon France
Atxnjbrrvc Pydjapha Hobfiudr De Mwgsgdlug Marseille France
Bsinemhj Uamfedspxn Hmzxoybz Cmbqhj Besançon France
Chtfds Hrgstjveacn Rxadlbyf Utxlwbklgnpts Dr Tmffb Tours France
Hgvoatme Uxqfrhzbogzesc Sojthymasp &cdnyei Hpgdihl dh Hyazwtyerxm STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.10.2025

Trial locations

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.

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 ID:
2024-518385-26-01
Protocol code:
29BRC23.0160
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Leflunomide for Preventing Relapses in Patients with Polymyalgia Rheumatica During Steroid Reduction

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Diagnostic Accuracy of 68Ga‑FAPI‑46 PET/CT in Patients with Suspected Giant Cell Arteritis and Polymyalgia Rheumatica

    Not yet recruiting

    2 1 1
    The Netherlands