RecruitingPHASE3INTERVENTIONAL

Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica

This study is investigating a new treatment for Polymyalgia Rheumatica (PMR), a condition that causes pain and stiffness, mainly in older adults. Currently, steroids are the main treatment, but they can cause side effects over time. The study is testing a drug called baricitinib, given as a pill, in combination with steroids. We want to see if baricitinib can help people reduce their steroid dose sooner or use less steroids overall, while effectively managing their PMR. The study will compare two different doses of baricitinib against a dummy pill (placebo) to find the best balance of effectiveness and safety. This research aims to offer a new way to treat PMR with potentially fewer long-term side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Brest

Enrolment target

140

Start

18 Dec 2025

Estimated completion

01 Jun 2029

Polymyalgia Rheumatica (PMR)

What is this study about?

Polymyalgia Rheumatica (PMR) is a condition that causes stiffness and pain, often in the shoulders, neck, and hips. It usually affects people over 50. The main treatment for PMR is a type of medicine called corticosteroids (often referred to simply as steroids). While steroids are very effective at reducing pain and inflammation, they can have unwanted side effects, especially when taken for a long time. These can include issues like bone thinning (osteoporosis) and an increased risk of heart problems.

Because of these side effects, doctors are looking for better ways to treat PMR that might reduce the need for long-term steroid use. This study is focusing on a new drug called baricitinib. Baricitinib works by blocking certain signals in the body that cause inflammation. Previous research suggests that baricitinib might be able to control PMR with less reliance on steroids, potentially leading to fewer side effects for patients.

In this study, we want to see if a 6-month course of baricitinib, given in combination with steroids, can help people reduce their steroid dose safely and effectively, and keep their PMR under control without steroids in the long run. We will be comparing two different doses of baricitinib with a dummy pill (placebo) to understand its benefits and how safe it is. This is important because having more treatment options could help many people with PMR lead healthier lives with fewer medication-related problems.

Key takeaways

New drug (baricitinib) is being tested for PMR.
Aims to reduce reliance on long-term steroids.
Compares two baricitinib doses against a dummy pill.
Study involves regular clinic visits for monitoring.
Potential for fewer steroid side effects.

Who may be eligible?

To join this study, you need to be at least 50 years old and have been diagnosed with Polymyalgia Rheumatica (PMR). Your PMR should be either newly diagnosed or not fully controlled by existing treatments. You shouldn't be taking more than 15mg of steroids per day for at least two weeks before joining, or no steroids at all. Also, your PMR symptoms must be active enough to meet certain study scores.

You cannot join the study if you have another inflammatory condition like giant cell arteritis, or certain uncontrolled health problems such as high blood pressure or heart disease. There are also specific rules about blood test results, a history of blood clots, being a smoker over 65, or having serious infections. You need to be a French health insurance holder and able to give your full agreement to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 50 years old or older?
Have you been diagnosed with Polymyalgia Rheumatica (PMR)?
Are you taking less than 15mg of steroids daily, or no steroids at all, for the past 15 days?
Do you have active PMR symptoms?
Do you not have other serious inflammatory conditions like giant cell arteritis or uncontrolled health problems?
Are you a French health insurance holder?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either one of two doses of baricitinib or a dummy pill (placebo) to take. You will continue to take steroids as directed by the study doctors, who will monitor your progress closely to see if your steroid dose can be reduced. Throughout the study, you will have regular visits to the clinic for check-ups, blood tests, and to discuss how you're feeling. These visits will help the doctors assess how well the treatment is working and monitor for any side effects. The exact number and timing of visits will be explained by the study team, but the treatment part of the study will last for 6 months, followed by ongoing monitoring.

Potential risks and benefits

Participating in this study might offer a potential benefit if baricitinib helps to control your PMR better or allows you to reduce your steroid dose, which could lead to fewer long-term side effects from steroids. However, like all medicines, baricitinib has potential risks and side effects, and these will be carefully monitored by the study team. Previous research with similar drugs has shown some risks, including potential cardiovascular problems, infections, or a slight increase in cancer risk in some people. These risks are continuously being reviewed. You will receive detailed information about all known and potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (22)

VIDAL François
Verified postcode
Aix-en-Provence, France· Recruiting
LEGRAND Jean-Louis
Verified postcode
Arras, France· Not yet recruiting
Besançon-CIC
Verified postcode
Besançon, France· Recruiting
PRATI Clément
Verified postcode
Besançon, France· Recruiting
CHU de Bordeaux Pellegrin
Verified postcode
Bordeaux, France· Not yet recruiting
Dr Alain SARAUX
Verified postcode
Brest, France· Recruiting
RAT Anne-Christine
Verified postcode
Caen, France· Recruiting
LESKE Charles
Verified postcode
Cholet, France· Recruiting
TOURNADRE Anne
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
RAMON André
Verified postcode
Dijon, France· Not yet recruiting
APHP - Kremlin-Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Not yet recruiting
DIREZ Guillaume
Verified postcode
Le Mans, France· Recruiting

Common questions

What is Polymyalgia Rheumatica (PMR)?

PMR is an inflammatory condition causing muscle pain and stiffness, especially in the shoulders, neck, and hips. It mostly affects people over 50.

What is baricitinib?

Baricitinib is a medicine taken as a pill that works by blocking certain signals in your body that cause inflammation. It's hoped it could help treat PMR.

Why is this study important?

Steroids, the main treatment for PMR, can have side effects over time. This study aims to find a new treatment that could reduce the need for long-term steroid use.

Will I still take my usual steroid medication?

Yes, you will continue with your steroid medication as directed by the study doctors. The aim is to see if baricitinib helps to reduce your steroid dose over time.

What is a placebo?

A placebo is a dummy pill that looks like the study drug but contains no active medicine. It helps researchers compare the real drug's effects more accurately.

How to find out more

Alain SARAUX, Pr

alain.saraux@chu-brest.fr +33298223333 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.