Study on Baricitinib for New-Onset Polymyalgia Rheumatica Patients to Reduce Steroid Use

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What is this study about?

This clinical trial is focused on studying the disease known as polymyalgia rheumatica, which is a condition that causes muscle pain and stiffness, especially in the shoulders. The trial will evaluate the effectiveness and safety of a medication called baricitinib, which is also known by its code names LY-3009104 and INCB-028050. The study will compare the effects of baricitinib with a placebo, which looks like the medication but does not contain the active ingredient. The goal is to see if baricitinib can help reduce the need for glucocorticoids, a type of steroid medication, in people with new-onset polymyalgia rheumatica.

Participants in the study will take either baricitinib or a placebo in the form of film-coated tablets. The study will be conducted over several weeks, with participants receiving either 2 mg or 4 mg doses of baricitinib. The treatment period will last up to 44 weeks, during which the participants’ progress will be monitored. The study aims to achieve remission of the disease without the use of glucocorticoids, which are commonly used to manage symptoms but can have side effects when used long-term.

The trial will assess various outcomes, including the proportion of participants who achieve remission without glucocorticoids at different time points, the total amount of glucocorticoids used, and the number of relapses experienced by participants. Additionally, the study will evaluate patient-reported outcomes such as fatigue and pain levels, as well as laboratory markers of inflammation. The safety of baricitinib will also be closely monitored, including any side effects or changes in health indicators. The study is expected to conclude by the end of 2025.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the actual medication or a placebo, which looks like the medication but does not contain the active ingredient.

2 medication administration

You will take the medication orally in the form of film-coated tablets. The medication is called Olumiant, which contains the active substance baricitinib. Depending on your group, you will receive either 2 mg or 4 mg tablets, or a placebo that matches the appearance of these tablets.

The medication will be taken daily as part of the study protocol.

3 glucocorticoid treatment

You will also receive a glucocorticoid treatment, specifically prednisone or prednisolone, starting at 20 mg per day. This dosage will be gradually reduced according to a pre-specified schedule.

4 monitoring and assessments

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular assessments of your condition, such as checking for signs of remission and any potential side effects.

You will be asked to report on your health status, including any changes in symptoms or new health concerns.

5 study duration

The study is divided into several parts, with key assessments at weeks 12, 16, 28, and 44. The primary goal is to evaluate the proportion of participants in glucocorticoid-free remission at week 16.

Secondary assessments will include cumulative glucocorticoid doses, number of relapses, and patient-reported outcomes such as fatigue and pain levels.

6 completion of the study

At the end of the study, your overall health and the effectiveness of the treatment will be evaluated. This will help determine the success of the treatment in managing your condition.

Who Can Join the Study?

Diagnosis of polymyalgia rheumatica (PMR) confirmed by the study doctor at the start and before the study begins. This means meeting specific criteria set in 2012 by two medical organizations, ACR and EULAR.
Diagnosis of PMR must have been made no more than 3 weeks before the first study visit.
Must not have taken glucocorticoids (GC), a type of steroid medication, for more than 3 weeks before the first study visit, with a starting dose of no more than 25 mg per day.
Willing and able to take oral prednisone or prednisolone, which are types of GC, at a dose of 20 mg per day when the study starts, and follow a plan to gradually reduce the dose.
Willing to take treatment to prevent bone loss caused by GC.
Willing and able to understand and follow the study procedures.
Male and female participants must agree to use effective birth control unless they cannot have children. This includes women who are infertile due to surgery, women aged 55 or older who are not on hormone therapy and have not had a period for at least 6 months, or women aged 55 or older who have been diagnosed with menopause.
Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.
Participants must be 50 years old or older.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received a live vaccine within the last 4 weeks.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who have a history of blood clots or bleeding disorders.
Patients who have uncontrolled high blood pressure.
Patients who have severe liver or kidney disease.
Patients who have a history of tuberculosis (TB) or have been in contact with someone with TB.
Patients who have a weakened immune system.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Central Hospital Of Bolzano	Bolzano	Italy
Klinik Hietzing	Vienna	Austria
Buhoxdc Hlwlekht (gcdix &lemeyj Ayaltl	Brunico	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	17.10.2024
Czechia	Not recruiting	17.10.2024
Italy	Not recruiting	17.10.2024

Trial locations

Investigated drugs:

Baricitinib

Baricitinib is a medication used in this clinical trial to help manage a condition called Polymyalgia Rheumatica. This condition causes pain and stiffness in the muscles, especially in the shoulders and hips. Baricitinib works by reducing inflammation in the body, which can help relieve these symptoms. In this study, Baricitinib is being tested to see if it can help patients achieve remission, which means the symptoms of the disease are reduced or disappear. It is also being evaluated to see if it can help reduce the need for glucocorticoids, which are another type of medication often used to treat this condition.

Investigated diseases:

Polymyalgia rheumatica

Polymyalgia Rheumatica – Polymyalgia rheumatica is an inflammatory disorder that primarily affects older adults, causing muscle pain and stiffness, especially in the shoulders and hips. The symptoms often appear suddenly and are more severe in the morning or after periods of inactivity. As the disease progresses, individuals may experience fatigue, mild fever, and a general feeling of being unwell. The stiffness and pain can lead to difficulty in performing daily activities, such as getting dressed or rising from a chair. The condition is associated with inflammation of the joints and surrounding tissues, but the exact cause remains unknown. Over time, the symptoms may fluctuate, with periods of improvement and worsening.

Trial ID:

2024-518556-22-00

Protocol code:

JAK-SPARE 1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Baricitinib for New-Onset Polymyalgia Rheumatica Patients to Reduce Steroid Use

What is this study about?

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