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Ilaris NIS in Korea

NCT ID: NCT06838143

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-29

Study Completion Date

2028-09-30

Brief Summary

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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

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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

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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)

Keywords

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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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ilaris

Patients treated with Ilaris in a clinical setting

Ilaris

Intervention Type BIOLOGICAL

Prospective observational study. There is no treatment allocation.

Interventions

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Ilaris

Prospective observational study. There is no treatment allocation.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CACZ885NKR01

Identifier Type: -

Identifier Source: org_study_id