Not recruiting

Study on Rituximab for Reducing Steroid Use in Newly Diagnosed Polymyalgia Rheumatica Patients

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 an inflammatory disorder that causes muscle pain and stiffness, especially in the shoulders. The study aims to see how effective rituximab is in treating this condition compared to a placebo. Rituximab is given as a solution through an intravenous infusion, which means it is administered directly into a vein.

The purpose of the study is to determine if rituximab can help reduce the need for glucocorticoids, which are a type of steroid medication often used to manage inflammation in polymyalgia rheumatica. Participants in the study will receive either rituximab or a placebo and will be monitored over a period of time to assess their response to the treatment. The study will look at various outcomes, such as the number of patients who can stop using glucocorticoids without their symptoms returning, and the overall improvement in their condition.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their symptoms. The study will also evaluate the safety of rituximab by monitoring any side effects that may occur. The goal is to find out if rituximab can be a beneficial treatment option for people with newly diagnosed polymyalgia rheumatica, potentially offering an alternative to long-term steroid use.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as having a newly diagnosed condition called polymyalgia rheumatica and having been on glucocorticoid treatment for less than 8 weeks.
You will be informed about the trial procedures, and any questions you have will be addressed. Consent will be obtained to ensure you understand and agree to participate in the study.
Step 2
Treatment phase
During the treatment phase, you will receive an intravenous infusion of rituximab. This medication is administered directly into your vein. The dosage and frequency will be determined by the study protocol.
You will be monitored closely for any side effects or reactions to the medication. Regular check-ups will be scheduled to assess your response to the treatment.
Step 3
Follow-up visits
You will have follow-up visits at specified intervals to monitor your progress. These visits will include assessments of your condition, such as measuring pain, fatigue, stiffness, and physical function.
The goal is to evaluate the effectiveness of the treatment in reducing your need for glucocorticoids, a type of steroid medication, and to check for any disease relapses or recurrences.
Step 4
End of study evaluation
At the end of the study, a final evaluation will be conducted. This will include a comprehensive assessment of your health and the overall outcomes of the treatment.
The study aims to determine the proportion of patients who achieve remission without the need for glucocorticoids one year after receiving rituximab compared to a placebo.

Who can join the trial?

5 criteria

Patients must have a newly diagnosed condition called Polymyalgia Rheumatica (PMR), diagnosed within the last 12 weeks.
Patients should have been on glucocorticoid treatment for less than 8 weeks. Glucocorticoids are a type of medication used to reduce inflammation.
The dose of glucocorticoids, specifically prednisolone, should be less than 30 mg per day. Prednisolone is a type of glucocorticoid medication.
Both men and women can participate in the study.
Participants should not belong to a vulnerable population, meaning they should not be in a group that requires special protection or care.

Who cannot join the trial?

9 criteria

Patients who have been diagnosed with any other autoimmune disease. An autoimmune disease is when the body's defense system attacks its own cells.
Patients who have received treatment with **rituximab** or any similar medication in the past. Rituximab is a drug used to treat certain autoimmune diseases and cancers.
Patients who have a history of severe allergic reactions to medications. An allergic reaction is when the body reacts badly to a substance, causing symptoms like rash, swelling, or difficulty breathing.
Patients who are currently participating in another clinical trial. A clinical trial is a research study to test new treatments.
Patients who have a serious infection. An infection is when harmful germs enter the body and cause illness.
Patients who have a history of cancer within the last 5 years, except for certain types of skin cancer. Cancer is a disease where cells in the body grow uncontrollably.
Patients who are pregnant or breastfeeding. Pregnant means expecting a baby, and breastfeeding means feeding a baby with milk from the breast.
Patients who have a history of drug or alcohol abuse. Abuse means using substances in a harmful way.
Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Gelre Hospitals
Zutphen, The Netherlands
Responsive
Sint Franciscus Vlietland Groep Stichting
Rotterdam, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Rituximab is a medication used in this clinical trial to help treat patients with a condition called polymyalgia rheumatica. This condition causes pain and stiffness in the muscles, especially around the shoulders and hips. Rituximab works by targeting specific cells in the immune system that may be causing inflammation and pain. The goal of using rituximab in this trial is to see if it can reduce the need for other medications, like glucocorticoids, which are commonly used to manage symptoms but can have side effects when used for a long time.

Rituximab

What is already known about the treatment

Rituximab – Rituximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating polymyalgia rheumatica, a condition that causes muscle pain and stiffness. Rituximab works by targeting and reducing certain cells in the immune system that are involved in inflammation. It is classified as a monoclonal antibody, which is a type of medication designed to specifically target and bind to proteins in the body.

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. 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 out of bed or lifting the arms. Over time, the inflammation can cause muscle weakness and reduced range of motion. The condition is often associated with an increased risk of developing giant cell arteritis, another inflammatory disease.