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Study on Rituximab for Patients with Relapsing Polymyalgia Rheumatica to Reduce Steroid Use

Verified siteRegistered 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 the effects of a medication called rituximab on a condition known as polymyalgia rheumatica. Polymyalgia rheumatica is a disease that causes muscle pain and stiffness, especially in the shoulders. The study aims to see if rituximab can help reduce the need for glucocorticoids, which are a type of steroid medication often used to manage symptoms of this disease. The trial will compare the effects of rituximab to a placebo, which is a substance with no active medication.

The purpose of the study is to determine how effective rituximab is in treating patients with relapsing polymyalgia rheumatica, meaning the disease symptoms return after initially improving. Participants in the study will receive either rituximab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period of time to see if they can achieve remission, which means the symptoms of the disease are reduced or disappear, without needing glucocorticoids.

Throughout the study, researchers will observe how many patients can maintain remission without glucocorticoids at different time points, such as after one year and two years. They will also track any relapses, which are times when the disease symptoms return, and any side effects that may occur. The study will help to understand if rituximab can be a beneficial treatment option for people with polymyalgia rheumatica who experience relapses and need to reduce their use of glucocorticoids.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of polymyalgia rheumatica (PMR) and difficulty reducing glucocorticoid dosage below 5 mg per day.

  2. Step 2

    Initial treatment phase

    The treatment involves the administration of rituximab, which is given intravenously. The dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and assessment

    Regular visits are scheduled to monitor the response to treatment. These visits assess the proportion of patients achieving glucocorticoid-free remission at various intervals, such as week 21 and week 52.

  4. Step 4

    Follow-up evaluations

    Follow-up evaluations continue up to two years to track remission status, disease relapses, and any additional treatments required. The study also examines changes in symptoms like pain and fatigue.

  5. Step 5

    Completion of study

    The study concludes with a final assessment of the treatment's effectiveness and any long-term effects. The estimated end date for the study is April 1, 2026.

Who can join the trial?

5 criteria

  • You must have a clinical diagnosis of **polymyalgia rheumatica (PMR)**, which is a condition that causes muscle pain and stiffness, according to specific guidelines from 2012.
  • You should have symptoms of PMR that have come back, along with high levels of certain markers in your blood called **ESR** (erythrocyte sedimentation rate) or **CRP** (C-reactive protein), which indicate inflammation.
  • You must be unable to lower your dose of a type of medication called **glucocorticoids** (like prednisolone) below 5 mg per day.
  • Both men and women can participate in the study.
  • The study is open to adults, typically those aged 18 and older.

Who cannot join the trial?

8 criteria

  • Patients who have any other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to similar treatments in the past.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of certain types of cancer.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Rituximab is a medication used in this clinical trial to treat patients with relapsing polymyalgia rheumatica. It works by targeting specific cells in the immune system that may be involved in causing inflammation and symptoms of the disease. The goal of using rituximab in this study is to see if it can effectively reduce the need for glucocorticoids, which are commonly used to manage symptoms in these patients.

What is already known about the treatment

Rituximab – Rituximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness in treating relapsing polymyalgia rheumatica, a condition characterized by muscle pain and stiffness. Rituximab works by targeting and depleting specific immune cells known as B cells, which play a role in the inflammation process. It is classified as a monoclonal antibody, a type of medication designed to bind to specific proteins in the body.

Investigated diseases

Polymyalgia Rheumatica – Polymyalgia rheumatica is an inflammatory disorder that causes muscle pain and stiffness, especially in the shoulders and hips. It typically affects older adults and can develop suddenly. The stiffness is often worse in the morning or after periods of inactivity. The exact cause of the condition is unknown, but it is believed to involve the immune system attacking healthy tissues. Symptoms can fluctuate, with periods of improvement and worsening. It is often associated with giant cell arteritis, another inflammatory condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513545-37-00Estimated enrolment174 patientsSponsorSint Maartenskliniek

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