Ilaris NIS in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ilaris.
- Who it may be relevant to
- Registry conditions: Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS). Basic parameters: 2 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Biological Ilaris
Prospective observational study. There is no treatment allocation.
Primary outcome measures
- Incidence of adverse events and serious adverse events [Time frame: Up to 104 weeks from Ilaris treatment]
Secondary outcome measures (9)
- Proportion of complete responders [Time frame: Up to 16 weeks from Liars treatment]
- Proportion of participants with Physician Global Assessment of Disease Activity (PGA) score <2 [Time frame: Up to 104 weeks from Ilaris treatment]
- Proportion of patients with C- reactive protein (CRP) serological response [Time frame: Up to 104 weeks from Ilaris treatment]
- Proportions of patients with serum amyloid A (SAA) normalization [Time frame: Up to 104 weeks from Ilaris treatment]
- Proportion of patients classified in each severity level in the physician's severity assessment of key disease -specific signs and symptoms [Time frame: Up to 104 weeks from Ilaris treatment]
- Proportions of patients classified in each severity level in symptoms likely to significantly affect affect physical functioning and vital prognosis [Time frame: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by Child Health Questionnaire-Parent Form 50 (CHQ-PF50) [Time frame: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by 36-item Short Form Health Survey (SF-36) [Time frame: Up to 104 weeks from Ilaris treatment]
- Percent change from baseline in Health related quality of life (HRQOL) measured by Work Productivity and Activity Impairment Specific Health Problem v2.0 (WPAI-SHP) [Time frame: Up to 104 weeks from Ilaris treatment]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Novartis Investigative Site — Seoul
Identifiers
NCT: NCT06838143 · CACZ885NKR01