Ongoing, recruitingTherapeutic use (Phase IV)Interventional

REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

This study, called REDUCE PMR, is for people recently diagnosed with polymyalgia rheumatica. It aims to see if a medicine called rituximab can help patients reduce or even stop their steroid medication (glucocorticoids) after one year, compared to those who receive a dummy treatment (placebo). Steroids are often used to treat polymyalgia rheumatica, but they can have side effects. Researchers want to know if rituximab can help people manage their condition with fewer steroids. They will look at how many people are off steroids, how much steroid they need, how their symptoms change, and any side effects over two years to understand if rituximab is a helpful treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Sint Maartenskliniek Stichting

Enrolment target

114

Start

28 Nov 2024

Polymyalgia Rheumatica

What is this study about?

This research study is about a condition called polymyalgia rheumatica (PMR). If you have PMR, you might experience pain and stiffness in your shoulders, neck, and hips. Doctors often treat PMR with medicines called steroids (also known as glucocorticoids). While steroids are good at controlling symptoms, using them for a long time can lead to side effects.

This study is looking at a different medicine called rituximab. Rituximab is already used for some other conditions, and researchers want to see if it can help people with newly diagnosed PMR reduce the amount of steroids they need, or even stop taking them altogether. The main goal is to find out if more people treated with rituximab are able to be free from steroids one year after starting the treatment, compared to those who receive a dummy treatment.

Over two years, the study will also track other important things. This includes how much steroid medication people take, how their pain, stiffness, and overall physical ability change, and if their PMR symptoms come back. By carefully comparing rituximab to a dummy treatment, doctors hope to learn if rituximab could be a useful new way to manage PMR and help patients rely less on steroids.

Key takeaways

This study evaluates rituximab for new polymyalgia rheumatica.
The main goal is to see if it helps reduce or stop steroid use after one year.
It lasts two years with regular check-ups.
Participants will receive rituximab or a dummy treatment, randomly.
It aims to find new ways to manage PMR with potentially fewer steroid side effects.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with polymyalgia rheumatica. Participants must be at least 18 years old; there is no upper age limit.

Both men and women can take part in this research.

Specific medical details, which your doctor will be able to discuss with you, will determine if you are a good fit for this study. It's important that the study treatment is safe and appropriate for your individual health situation.

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 18 years old or older?
Have you been recently diagnosed with polymyalgia rheumatica?
Are you able to attend regular clinic visits for two years?
Are you willing to potentially receive either the study medicine or a dummy treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the study medicine, rituximab, or a dummy treatment (placebo). You wouldn't know which one you are getting, and neither would your study doctor. You would have several visits to the clinic over a period of two years. During these visits, the study team would check your health, ask about your symptoms (like pain and stiffness), and monitor the amount of steroid medication you are taking. You might also have blood tests and other assessments. The total duration of your participation would be for two years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help you reduce your steroid medication. However, any medicine can have side effects, and rituximab is no exception. There might be side effects related to the study medicine, or risks associated with the study procedures, such as blood tests. All potential risks will be fully explained by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is polymyalgia rheumatica?

It's a condition that causes pain and stiffness in your shoulders, neck, and hips. It's more common in older adults.

What are 'glucocorticoids'?

These are steroid medicines, often called prednisolone, that doctors frequently prescribe to treat polymyalgia rheumatica. They help reduce inflammation.

What is 'rituximab'?

Rituximab is a different type of medicine. It's used for some other conditions, and in this study, we're seeing if it can help people with polymyalgia rheumatica.

Will I know if I'm getting the real medicine or a dummy treatment?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're receiving rituximab or the dummy treatment until the study is over.

How long does the study last?

Your participation in the study would last for two years.

How to find out more

Official trial record

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