Ilaris for periodic fever syndromes and systemic juvenile idiopathic arthritis in Korea
Official title: 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)
Run by Novartis · NCT06838143 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 2 Years to 100 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 29, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT06838143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Novartis Investigative Site
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.