Real Life Non-interventional Study on Safety and Effectiveness of Ilaris (Canakinumab) 150 mg for Subcutaneous Injection in Hereditary Periodic Fever Syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) Patients and sJIA Patients (REASSURE)

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drug Ilaris (Canakinumab) in both adult and pediatric patients who have hereditary periodic fever syndromes, including Cryopyrin-associated periodic syndromes (CAPS), colchicine-resistant familial Mediterranean fever (crFMF), TNF receptor associated periodic syndrome (TRAPS), Hyper-IgD syndrome / Mevalonate kinase deficiency (HIDS/MKD), and systemic juvenile idiopathic arthritis (sJIA). This prospective observational study collects data from patients receiving Ilaris in a real-world clinical setting to better understand its impact on these conditions. The study is open-label, multicenter, and includes both retrospective and prospective data collection. Participants receive Ilaris as part of their routine clinical care without treatment allocation, meaning there is no placebo or comparator group. The study includes patients aged 2 years and older, with both pediatric and adult groups. The study period lasts up to 4 years, consisting of a 2-year enrollment period followed by a 2-year observation period. For those who started Ilaris before joining the study, baseline and early treatment data will be collected retrospectively. During the study, researchers will monitor participants for adverse events and serious adverse events for up to 104 weeks after starting Ilaris treatment. They will also assess treatment response, including physician global assessment scores, serological markers like C-reactive protein and serum amyloid A, and disease severity. Quality of life will be measured using questionnaires such as the Child Health Questionnaire-Parent Form 50, SF-36, and Work Productivity and Activity Impairment surveys. Safety and effectiveness data will help provide a comprehensive picture of Ilaris use in these patient groups.

Ilaris NIS in Korea