Recruiting

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

Registered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying polymyalgia rheumatica, a condition that causes muscle pain and stiffness, especially in the shoulders. The study will use a medication called leflunomide, which is taken as a film-coated tablet. Participants in the study will either receive leflunomide or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to investigate whether using leflunomide can help prevent relapses, or the return of symptoms, in patients with polymyalgia rheumatica who are reducing their use of corticosteroids, a type of medication often used to treat this condition. The study will involve taking the medication or placebo orally, meaning by mouth, over a period of time.

Participants will be monitored to see how long it takes for a relapse to occur within a 12-month period. The study aims to provide more information on the effectiveness of leflunomide in managing polymyalgia rheumatica and helping patients maintain their health while tapering off corticosteroids.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: age 50 or older, diagnosed with polymyalgia rheumatica (PMR) according to established guidelines, and having been on corticosteroids for less than four weeks.
Step 2
Randomization
Participants are randomly assigned to receive either leflunomide or a placebo. This process ensures that the study results are unbiased.
Step 3
Medication administration
The medication is administered orally in the form of film-coated tablets. Participants take either leflunomide 10 mg or a placebo as directed by the study protocol.
Step 4
Treatment duration
The treatment continues for a specified period, with the primary goal of assessing the time to the first relapse within 12 months.
Step 5
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment and to ensure participant safety.
Step 6
Completion of the study
The study is estimated to conclude by April 1, 2028. Participants will be informed of the study's findings and any relevant outcomes.

Who can join the trial?

3 criteria

Must be a female or male who is **50 years old or older**.
Must have **polymyalgia rheumatica (PMR)**, which is a condition that causes muscle pain and stiffness, diagnosed according to specific guidelines from 2012.
Must have been **recently diagnosed** with PMR and have been taking **corticosteroids** (a type of medication used to reduce inflammation) for **less than 4 weeks**.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with polymyalgia rheumatica. This is a condition that causes muscle pain and stiffness, especially in the shoulders.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Investigated drugs

Leflunomide is a medication being studied for its potential to prevent relapses in patients with polymyalgia rheumatica, especially during the period when corticosteroid treatment is being reduced. It is being tested to see if it can help maintain the benefits of treatment while reducing the need for corticosteroids, which can have significant side effects when used long-term.

What is already known about the treatment

Leflunomide – Leflunomide is administered orally in tablet form. It is currently being studied in clinical trials for its potential to prevent relapses in patients with polymyalgia rheumatica, especially during the reduction of corticosteroid use. The medication is primarily used to treat rheumatoid arthritis and works by inhibiting the synthesis of pyrimidine, which is essential for the proliferation of immune cells. This action helps reduce inflammation and immune response. Leflunomide is classified as a disease-modifying antirheumatic drug (DMARD).

Investigated diseases

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. The exact cause of the condition is unknown, but it is believed to involve immune system abnormalities. Over time, the stiffness and pain can lead to decreased range of motion and difficulty performing daily activities. The condition is often associated with fatigue, mild fever, and a general feeling of being unwell. It is not considered a rare disease and is more common in women than men.