NCT06838143

Ilaris NIS 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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes, Cryopyrin-associated periodic syndromes (CAPS), colchicine resistance familial Mediterranean fever (crFMF), TNF receptor associated periodic syndrome (TRAPS), Hyper-IgD syndrome / Mevalonate kinase deficiency (HIDS/MKD) or Systemic juvenile idiopathic arthritis (sJIA).

Detailed description

This is a prospective observational, multicenter, uncontrolled, open-label non-interventional study in ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome patients and ≥2 year and \<19 year-old sJIA patients receiving Ilaris for the treatment of CAPS, crFMF, TRAPS, HIDS/MKD and sJIA, respectively, partially using retrospective observation to collect and evaluate data on the safety and effectiveness of Ilaris in patients receiving this drug in a clinical setting for any of these indications. The whole study period is up to 4 years, consisting of a 2-year enrollment period and 2-year observation period. As all pediatric and adult hereditary periodic fever syndrome patients and all sJIA patients receiving Ilaris for approved indications will be enrolled, this study has no fixed sample size. For subjects who started Ilaris before enrolling in this study, the safety and effectiveness baseline and early period data will be retrospectively collected.

Conditions

• Hereditary Periodic Fever Syndromes
• Cryopyrin-associated Periodic Syndromes (CAPS)
• Colchicine Resistance Familial Mediterranean Fever (crFMF)
• TNF Receptor Associated Periodic Syndrome (TRAPS)
• Hyper-IgD Syndrome / Mevalonate Kinase Deficiency (HIDS/MKD)
• Systemic Juvenile Idiopathic Arthritis (sJIA)

Interventions

Type	Name	Description
BIOLOGICAL	Ilaris	Prospective observational study. There is no treatment allocation.

Timeline

• Start date: 2025-03-29
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-02-20
• Last updated: 2025-12-30

Locations

1 site across 1 country: South Korea