Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of Baricitinib as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects with New-Onset Polymyalgia Rheumatica (JAK-SPARE 1)

This research study is investigating a new medicine called Olumiant for people who have recently been diagnosed with polymyalgia rheumatica. Polymyalgia rheumatica is a condition that causes stiffness and pain in the muscles, especially in the neck, shoulders, and hips. Currently, steroid medications (like prednisolone) are a common treatment, but they can have side effects. The main goal of this study is to find out if Olumiant can help people go into remission (meaning their symptoms improve significantly or disappear) without needing to take as many steroids, or even any steroids at all. Researchers will also be carefully checking how safe Olumiant is during the study. This is a "Phase III" study, which means it's a large, important step in testing new treatments to see if they should be approved for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medical University Of Vienna

Enrolment target

Start

09 Dec 2024

polymyalgia rheumatica

What is this study about?

This research study, called JAK-SPARE 1, is focused on a condition called polymyalgia rheumatica. This condition often causes pain and stiffness, particularly in the shoulders, neck, and hips. Many people with polymyalgia rheumatica are treated with steroid medications, like prednisolone, which can be very effective but may also cause side effects, especially if taken for a long time. The study is hoping to find new ways to treat this condition that might reduce the reliance on these steroids.

The study is testing a medication called Olumiant (also known as baricitinib). Researchers want to see if Olumiant can help people with polymyalgia rheumatica achieve \ remission\ – a period where the symptoms are much better or gone – and reduce or even stop the need for steroid medications. This is important because finding effective treatments that minimise steroid use could greatly improve the lives of people with this condition.

To make sure the results are fair and accurate, this study is \ double-blinded\ . This means that neither the participants nor their study doctors will know whether they are receiving Olumiant or a \ placebo\ (a dummy pill that looks exactly like Olumiant but contains no active medicine). This helps to prevent any bias in the results. Researchers will be carefully monitoring how participants feel, their symptoms, and any side effects throughout the study to understand the full picture of how Olumiant works.

Key takeaways

This study is testing Olumiant for recently diagnosed polymyalgia rheumatica.
The main goal is to see if Olumiant can help people achieve remission and reduce steroid use.
Participants will receive either Olumiant or a placebo.
Close medical monitoring and regular visits are required.
It's a large, important study (Phase III) to evaluate effectiveness and safety.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 years or older, regardless of whether you are male or female. The study is specifically looking for people who have recently been diagnosed with polymyalgia rheumatica.

There might be other specific criteria, such as your general health, other medications you are taking, or if you have certain medical conditions. These details are important to ensure the study is safe for you and that the results are clear.

If you have polymyalgia rheumatica and are interested, your doctor or the study team will discuss all the specific requirements with you to see if this study could be a good fit.

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 recently been diagnosed with polymyalgia rheumatica?
Are you able to attend regular clinic visits?
Are you willing to potentially take either the study drug or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would either receive Olumiant (in a 2mg or 4mg tablet form) or a placebo tablet. These tablets would look identical, so neither you nor your study doctor would know which one you are taking. You would take the medication as directed by the study team.

Throughout the study, you would have regular visits to the clinic. During these visits, the study team would check your health, ask about your symptoms (like pain and stiffness), perform blood tests to look at inflammation, and ask you to complete questionnaires about how you are feeling and how the condition affects your daily life. They will also monitor your steroid use.

The study will closely follow your progress over several months. This includes checking if your symptoms improve, how much steroid medication you need, and any side effects you might experience. The exact number of visits and the total duration would be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new treatment and very close medical monitoring, which might otherwise not be available. However, there are also potential risks, including side effects from the study medication. These side effects can vary from mild to more serious, and the study team will monitor you closely for them. Because you might receive a placebo, you may not experience the active drug's effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Austria
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Unverified
Czechia
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Unverified
Italy

Common questions

What is polymyalgia rheumatica?

It's a condition causing pain and stiffness, usually in the shoulders, neck, and hips, which is often worse in the morning.

What is Olumiant?

Olumiant (baricitinib) is a medicine that works by calming down parts of the immune system and is being tested for polymyalgia rheumatica.

What does 'double-blind' mean?

It means neither you nor your study doctor will know if you are receiving the active medicine or a dummy pill (placebo) until the study ends.

What is a 'placebo'?

A placebo is a tablet that looks identical to the study medicine but doesn't contain any active drug. It helps compare the new medicine's effects accurately.

Why is this study important?

It aims to find new, effective treatments for polymyalgia rheumatica that might help people reduce their reliance on steroid medications, which often have side effects.