RecruitingNCT06838143

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

25 participants

Start Date

Mar 29, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 2 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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
  • 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
  • Patient who have an agreement to be treated or who have already started treatment with Ilaris in accordance with the approved label information

Exclusion Criteria2

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

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Interventions

BIOLOGICALIlaris

Prospective observational study. There is no treatment allocation.


Locations(1)

Novartis Investigative Site

Seoul, South Korea

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NCT06838143


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