Filgotinib for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Diagnosis of RA according to the ACR/EULAR 2010 criteria\n- Moderate to high disease activity defined as a Disease Activity Score 28 (DAS28) ≥3.2\n- Clinical indication for treatment with a JAK inhibitor\n- No changes to pharmacological therapy in last 4 weeks\n- Age 40-70 years"}

Exclusion criteria

• {"criterion_text":"- Symptoms of angina or heart failure\n- Participation in a trial with an investigational drug or treatment\n- History of noncompliance with medical therapy\n- Unwilling or unable to provide written informed consent or comply with the study protocol\n- Life expectancy less than 1 year\n- Left main stenosis >50% on CCTA\n- 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.\n- 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)\n- 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.\n- Contraindications to treatment with JAK inhibitors (e.g. history of deep vein thrombosis or pulmonary embolism, known malignancy, planned major surgery, active infection)\n- Current smoking\n- Estimated Glomerular Filtration Rate <30 mL/min/1.73m2\n- Pregnancy"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"LV function will be assessed at baseline and follow-up using CMR measurements of global circumferential, longitudinal and radial strain."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Comparisons include endpoints derived from CMR, endpoints derived from CCTA, and clinical treatment evaluation; and comparisons between RA patients and age- and sex-matched healthy volunteers using CMR- and CCTA-derived measures."}

Netherlands

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

09-07-2025

Processing Time Days

169

Number Of Sites

4

Number Of Participants

105

Primary sponsor

Full Name

Reade revalidatie & reumatologie centrum te Amsterdam

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands