Ilaris NIS in Korea (REASSURE)

Novartis

Status: Enrolling

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

Treatments: Biological: Ilaris

Study type: Observational

Funder types: Industry

Identifiers

NCT06838143

CACZ885NKR01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 2 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Ilaris

Description:

Patients treated with Ilaris in a clinical setting

Treatment:

Biological: Ilaris