Ilaris for periodic fever syndromes and systemic juvenile idiopathic arthritis in Korea

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)

This will test how safe and effective Ilaris is for children and adults in Korea who are being treated for hereditary periodic fever syndromes or systemic juvenile idiopathic arthritis.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 2 Years to 100 Years
• Sex: All
• Sponsor: Novartis (industry)
• Locations: 1 site (Seoul)
• Trial ID: NCT06838143 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, uncontrolled, open-label non-interventional study enrolling pediatric (age 2–18) and adult (19+) patients in Korea who are receiving Ilaris for CAPS, crFMF, TRAPS, HIDS/MKD, or sJIA. The study combines prospective observation with retrospective baseline data for patients who started Ilaris before enrollment and follows participants for up to 2 years of observation after a 2-year enrollment period (total up to 4 years). Treatments follow routine clinical care and approved labeling rather than protocol-driven interventions, and there is no fixed sample size because all eligible treated patients at participating sites will be included. Safety and effectiveness events will be collected and summarized to describe real-world use of Ilaris in these indications.

Who should consider this trial

Good fit: Children aged 2–18 and adults aged 19+ in Korea who are receiving Ilaris for CAPS, colchicine-resistant FMF, TRAPS, HIDS/MKD, or sJIA and who provide informed consent are eligible.

Not a fit: Patients receiving Ilaris for autoimmune diseases other than the listed indications, those enrolled in other interventional trials that impact routine care, children under age 2, or people not treated per the approved label may not benefit from this registry.

Why it matters

Potential benefit: If successful, this could provide real-world safety and effectiveness data to help clinicians and families make informed treatment decisions for these rare inflammatory conditions.

How similar studies have performed: Randomized trials and observational reports have previously shown canakinumab (Ilaris) is effective for CAPS and sJIA and has benefit in other periodic fever syndromes, so this study aims to confirm those effects in routine clinical practice in Korea.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent/assent of the patient or their legal representative/parent (≥2 year and \<19 year-old pediatric patient) for voluntarily participating in this study
2. Age: ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) patients and ≥2 year and \<19 year-old sJIA patients
3. Patient who have an agreement to be treated or who have already started treatment with Ilaris in accordance with the approved label information

Exclusion Criteria:

1. Patients receiving Ilaris treatment for autoimmune disease other than CAPS, crFMF, TRAPS, HIDS/MKD or sJIA
2. Patients participating in an interventional clinical trial which would have an impact on routine clinical treatment

Where this trial is running

Seoul

• Novartis Investigative Site — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes, Colchicine Resistance Familial Mediterranean Fever, TNF Receptor Associated Periodic Syndrome, Hyper-IgD Syndrome / Mevalonate Kinase Deficiency, Systemic Juvenile Idiopathic Arthritis, Cryopyrin-associated periodic syndromes, colchicine resistance familial Mediterranean fever