Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Filgotinib on Heart Health in Patients with Rheumatoid Arthritis Without Cardiovascular Disease

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Jyseleca, which contains the active substance filgotinib, on individuals with Rheumatoid Arthritis. Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects the joints, leading to pain and swelling. The study aims to explore how this medication, which is a type of Janus Kinase inhibitor, impacts heart health in patients with this condition.

The purpose of the study is to investigate the effect of Janus Kinase inhibitors on heart function, heart muscle inflammation, and the structure of coronary arteries in patients with Rheumatoid Arthritis. Participants will be given Jyseleca in the form of film-coated tablets, taken orally. The study will compare heart health before and after one year of treatment with this medication. Some participants will receive a placebo for comparison.

Throughout the study, participants will undergo various assessments to monitor changes in heart function and overall health. These assessments will help researchers understand the potential benefits and risks of using filgotinib for treating Rheumatoid Arthritis, particularly in relation to heart health. The study is expected to continue until early 2026, providing valuable insights into the treatment of this condition.

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

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of rheumatoid arthritis according to specific criteria and ensuring no history of cardiovascular diseases.

    The assessment will also check for moderate to high disease activity and confirm that there have been no changes to your medication in the last four weeks. Age eligibility is between 40 and 70 years.

  2. Step 2

    Baseline measurements

    Baseline measurements will be taken to assess heart function. This involves using a technique called CMR (cardiac magnetic resonance) to measure heart muscle strain in different directions.

    These measurements will help understand the starting point of your heart's function before beginning the treatment.

  3. Step 3

    Medication administration

    You will begin taking the medication Jyseleca, which contains the active substance filgotinib. This is provided in the form of 200 mg film-coated tablets.

    The medication is taken orally, once daily, for a duration of one year.

  4. Step 4

    Follow-up assessments

    Throughout the year, follow-up assessments will be conducted to monitor changes in heart function and overall health.

    These assessments will include repeated CMR measurements to compare with baseline data and evaluate the effects of the medication.

  5. Step 5

    Final evaluation

    At the end of the one-year period, a final evaluation will be conducted. This will involve a comprehensive review of heart function and any changes observed during the study.

    The results will be compared with those of healthy volunteers to understand the impact of the treatment on heart health in patients with rheumatoid arthritis.

Who can join the trial?

5 criteria

  • Must have a diagnosis of Rheumatoid Arthritis (RA) according to specific medical criteria.
  • Must have moderate to high disease activity, which means a Disease Activity Score 28 (DAS28) of 3.2 or higher. DAS28 is a measure of how active the arthritis is.
  • Must have a clinical indication for treatment with a JAK inhibitor. JAK inhibitors are a type of medication used to treat RA.
  • Must not have made any changes to their medication in the last 4 weeks.
  • Must be between the ages of 40 and 70 years.

Who cannot join the trial?

2 criteria

  • Patients with a history of cardiovascular diseases cannot participate. This means if you have had heart-related issues in the past, you are not eligible.
  • Patients who do not meet the ACR/EULAR 2010 criteria for diagnosing rheumatoid arthritis are excluded. These are specific guidelines used by doctors to diagnose rheumatoid arthritis.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Janus Kinase Inhibitors are a type of medication used to treat rheumatoid arthritis. They work by blocking certain enzymes in the body that are involved in the inflammation process. By doing this, they help reduce swelling, pain, and damage in the joints. In this clinical trial, researchers are studying how these inhibitors affect the heart, particularly looking at heart function, inflammation in the heart muscle, and the condition of the blood vessels that supply the heart.

What is already known about the treatment

Janus Kinase Inhibitors – These medications are taken orally and work by blocking specific enzymes called Janus kinases, which play a role in the inflammation process. They are currently being studied for their effects on heart health in people with rheumatoid arthritis, a condition where the immune system mistakenly attacks the joints. The main goal of using these inhibitors is to reduce inflammation and prevent joint damage, and researchers are now exploring how they might also protect the heart by reducing inflammation and changes in heart structure. Janus kinase inhibitors are classified as targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joint. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. As the condition advances, it can lead to joint deformity and loss of function. In addition to joint issues, rheumatoid arthritis can also affect other systems in the body, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520710-58-00Protocol codeNL77572.029.21Estimated enrolment105 patientsSponsorReade revalidatie & reumatologie centrum te Amsterdam

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.