Ilaris NIS in Korea

NCT06838143 | Recruiting

• 1 other identifier: CACZ885NKR01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and serious adverse events

  Adverse events and serious adverse events in hereditary periodic fever syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) and sJIA patients treated with Ilaris.

  Up to 104 weeks from Ilaris treatment

Secondary Outcomes (9)

• Proportion of complete responders

  Up to 16 weeks from Liars treatment

• Proportion of participants with Physician Global Assessment of Disease Activity (PGA) score <2

  Up to 104 weeks from Ilaris treatment

• Proportion of patients with C- reactive protein (CRP) serological response

  Up to 104 weeks from Ilaris treatment

• Proportions of patients with serum amyloid A (SAA) normalization

  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

  Up to 104 weeks from Ilaris treatment

Study Arms (1)

Ilaris

Patients treated with Ilaris in a clinical setting

Biological: Ilaris

Interventions

Ilaris BIOLOGICAL

Prospective observational study. There is no treatment allocation.

Ilaris

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

≥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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Hereditary Autoinflammatory Diseases; Cryopyrin-Associated Periodic Syndromes; Periodic fever, familial, autosomal dominant; Mevalonate Kinase Deficiency; Arthritis, Juvenile

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Cold Urticaria; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Metabolism, Inborn Errors; Peroxisomal Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunoproliferative Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: March 29, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)