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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Reade revalidatie & reumatologie centrum te Amsterdam

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-01-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520710-58-00

EudraCT number

2021-005045-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate the effect of Janus kinase inhibitors in patients with rheumatoid arthritis on cardiac function, myocardial inflammation and coronary plaque morphology.

Secondary objectives 1

1. To assess differences in cardiac function, myocardial inflammation and coronary plaque morphology between patients with rheumatoid arthritis and a control group of age- and sex-matched, healthy volunteers

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Diagnosis of RA according to the ACR/EULAR 2010 criteria
2. Moderate to high disease activity defined as a Disease Activity Score 28 (DAS28) ≥3.2
3. Clinical indication for treatment with a JAK inhibitor
4. No changes to pharmacological therapy in last 4 weeks
5. Age 40-70 years

Exclusion criteria 13

1. Symptoms of angina or heart failure
2. Left main stenosis >50% on CCTA
3. History of hypertension, dyslipidaemia, diabetes mellitus, myocardial infarction, coronary revascularization, cardiac transplantation, pacemaker or implantable cardioverter defibrillator implantation, valvular disease, heart failure, second or third degree heart block, (supra)ventricular tachycardia or frequent premature atrial or ventricular complexes.
4. Contraindications to intravenous adenosine administration (e.g. Chronic Obstructive Pulmonary Disease stage IV or asthma, systemic hypotension with mean arterial blood pressure <70mm Hg, second or third degree AV nodal conduction disturbances)
5. Contraindications to CMR or CCTA (e.g. claustrophobia, ferromagnetic implants, known allergy to iodinated or gadolinium based contrast agents, weight or size exceeding the limits of the CMR or CCTA scanner.
6. Contraindications to treatment with JAK inhibitors (e.g. history of deep vein thrombosis or pulmonary embolism, known malignancy, planned major surgery, active infection)
7. Current smoking
8. Estimated Glomerular Filtration Rate <30 mL/min/1.73m2
9. Pregnancy
10. Participation in a trial with an investigational drug or treatment
11. History of noncompliance with medical therapy
12. Unwilling or unable to provide written informed consent or comply with the study protocol
13. Life expectancy less than 1 year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main study parameter is the change in LV function in RA patients after 1 year of treatment with filgotinib. LV function will be assessed at baseline and follow-up using CMR measurements of global circumferential, longitudinal and radial strain

Secondary endpoints 1

1. The comparisons between baseline and follow-up data in RA patients treated with filgotinib for 1 year. And comparisons between RA patients and age- and sex-matched healthy volunteers. The first category is subdivided into endpoints derived from CMR, endpoints derived from CCTA, and endpoints concerning clinical treatment evaluation. The second category is subdivided into endpoints derived from CMR and endpoints derived from CCTA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Reade revalidatie & reumatologie centrum te Amsterdam

Sponsor organisation

Reade revalidatie & reumatologie centrum te Amsterdam

Address

Admiraal Helfrichstraat 1

City

Amsterdam

Postcode

1056 AA

Country

Netherlands

Scientific contact point

Organisation

Reade revalidatie & reumatologie centrum te Amsterdam

Contact name

Sreen Mohamed

Public contact point

Organisation

Reade revalidatie & reumatologie centrum te Amsterdam

Contact name

Sreen Mohamed

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications