AuthorisedTherapeutic use (Phase IV)Interventional

The effect of Janus Kinase inhibitors on the heart in Rheumatoid Arthrtis

This research study is investigating the effects of a medication called Jyseleca (filgotinib) on the hearts of people living with Rheumatoid Arthritis (RA). Specifically, it's for individuals recently diagnosed with RA who haven't had any pre-existing heart conditions. The main goal is to see if taking Jyseleca for one year changes how well the heart's left side (called the left ventricle) works. Researchers will use special MRI scans of the heart to measure specific movements of the heart muscle at the beginning of the study and again after one year. This will help them understand if this treatment has any impact on heart function in RA patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Reade revalidatie & reumatologie centrum te Amsterdam

Enrolment target

105

Start

28 Jan 2025

Diagnosis of RA according to the ACR/EULAR 2010 criteria without a history of cardiovascular diseases Rheumatroid Arthritis

What is this study about?

This study is designed to understand how a specific medication, Jyseleca (which is the brand name for filgotinib), might affect the heart in people who have Rheumatoid Arthritis (RA). RA is a condition where the body's immune system mistakenly attacks its own joints, causing pain and swelling. We already know that people with RA can sometimes have a higher risk of heart problems.

Researchers want to see if taking Jyseleca, a common treatment for RA, changes how well the heart works. They are particularly interested in the left side of the heart, which is responsible for pumping blood out to the rest of the body. They will be carefully measuring whether the medicine causes any changes to the heart's pumping action and movement over a year.

To do this, participants will have detailed scans of their heart using a technique called Cardiac MRI (CMR) at the start of the study and then again after one year of treatment. They will also compare their heart information with healthy volunteers of similar age and gender to get a fuller picture. This study is important because it will help doctors and patients understand more about the full effects of RA treatments on overall health, especially for the heart.

Key takeaways

The study focuses on how Jyseleca (filgotinib) affects the heart in people with Rheumatoid Arthritis.
It's for people recently diagnosed with RA who haven't had any heart problems.
Heart function will be checked using special MRI scans before and after one year of treatment.
The main goal is to see if the medicine changes how well the heart's left side works.
This research aims to improve understanding of RA treatments and their impact on heart health.

Who may be eligible?

This study is looking for people who meet specific criteria. To take part, you need to have been diagnosed with Rheumatoid Arthritis (RA) using certain medical guidelines established in 2010. It's important that you haven't had any cardiovascular diseases, which means you shouldn't have a history of heart attacks, strokes, or other significant heart or blood vessel problems before joining the study.

Participants must be 18 years old or older. The study is open to both men and women. If you meet these general points, you might be able to take part.

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.

Have you been diagnosed with Rheumatoid Arthritis (RA) by a doctor?
Do you have a history of heart disease, heart attacks, or strokes?
Are you 18 years old or older?
Are you able to commit to one year of taking study medication and attending appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the study medication, Jyseleca film-coated tablets, which you will take for one year. You will have a detailed heart scan using a special MRI machine at the very beginning of the study. This is called your 'baseline' measurement. After taking the medication for one year, you will have another heart scan to see if there have been any changes. There will also be other assessments throughout the year, which might include blood tests and clinical checks, to make sure the treatment is suitable and to gather further information about your health. The total duration of your active participation in the study will be about one year.

Potential risks and benefits

By taking part, you could potentially help us learn more about how treatments for Rheumatoid Arthritis affect the heart, which could benefit future patients with RA. You will also receive careful monitoring of your heart health throughout the study. As with all medicines, there can be side effects, and the study medication Jyseleca has known risks, which your doctor will explain fully. You have the right 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 Rheumatoid Arthritis (RA)?

RA is a long-term condition that causes pain, swelling, and stiffness in the joints. It happens when your body's immune system attacks its own tissues.

What is Jyseleca (filgotinib)?

Jyseleca is a medicine used to treat Rheumatoid Arthritis. It works by blocking certain signals in your immune system that cause inflammation.

What does 'LV function' mean?

LV function refers to how well the 'Left Ventricle' of your heart is working. The left ventricle is the main pump that sends blood to your body.

What is a 'Cardiac MRI'?

A Cardiac MRI is a type of scan that uses strong magnets and radio waves to create detailed pictures of your heart, helping doctors see how it's structured and how it's working.

Why is this study important?

This study is important because it will help doctors understand more about how RA treatments like Jyseleca might affect the heart over time, helping to make future treatment decisions safer and more informed.