Who may be eligible for the Ilaris NIS in Korea trial?

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

ClinicalTrials.gov record NCT06838143

Ilaris NIS in Korea

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age2 years old to 100 years old

SexAll

LocationSouth Korea

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study collects safety and effectiveness information on Ilaris (canakinumab) given in routine care to people treated for hereditary periodic fever syndromes or systemic juvenile idiopathic arthritis (sJIA). It includes pediatric patients (≥2 to <19 years) receiving Ilaris for CAPS, crFMF, TRAPS, HIDS/MKD or sJIA, and people (≥19 years) receiving Ilaris for the hereditary periodic fever syndromes (CAPS, crFMF, TRAPS, HIDS/MKD) only. Data collection covers up to 4 years (2 years enrollment plus 2 years observation) and may include retrospective baseline and early-treatment data for people who started Ilaris before joining the study.

What it is studying. The study is collecting and evaluating safety (adverse events and serious adverse events) and measures of effectiveness for Ilaris when used in routine clinical practice, including physician assessments, inflammatory blood markers, and quality-of-life measures.

What the researchers hope to learn. Scientific goals are to describe the incidence of adverse events and serious adverse events with Ilaris, and to evaluate measures of disease response and control (including Physician Global Assessment, CRP and SAA changes, proportions of complete responders, symptom severity assessments, and health-related quality-of-life over time).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological: Ilaris

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have information about their Ilaris treatment and health collected from their medical records and during routine clinic visits; the study does not assign or change treatment. Collected data include reports of adverse events, physician assessments of disease activity (Physician Global Assessment), blood tests such as C-reactive protein (CRP) and serum amyloid A (SAA), and health-related quality-of-life questionnaires (CHQ-PF50, SF-36, WPAI-SHP). For people who started Ilaris before joining, some baseline and early treatment data will be collected retrospectively; thereafter participants are followed prospectively for up to 2 years after enrollment. The registry record lists these observational data collection activities and does not report additional invasive procedures (for example, biopsies or spinal taps).

How the study is structured. This is a prospective, observational cohort study without treatment allocation: participants receive Ilaris as prescribed by their usual doctor and the study records outcomes. It is multicenter and non-interventional, with up to 4 years of total data collection (2 years enrollment, 2 years follow-up). The study will collect physician global assessments of disease activity, laboratory markers such as C-reactive protein (CRP) and serum amyloid A (SAA), adverse event reports, and health-related quality-of-life questionnaires (for example CHQ-PF50, SF-36, WPAI-SHP). For people who started Ilaris before enrolling, some baseline and early-treatment information will be collected retrospectively.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on cryopyrin-associated periodic syndromes

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials5 trials listed for cryopyrin-associated periodic syndromesEvery trial the registry lists for cryopyrin-associated periodic syndromes, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in cryopyrin-associated periodic syndromes researchLatest monthly update: September 2026. Includes: Kidney damage risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 29, 2025
Primary completion: Sep 30, 2028 (estimated)
Study completion: Sep 30, 2028 (estimated)
Target enrollment: 25 participants (estimated)
Last updated on registry: May 19, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Novartis Pharmaceuticals

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Novartis Pharmaceuticals 📞 +41613241111 ✉ novartis.email@novartis.com
Novartis Pharmaceuticals

Participating sites (1)

Novartis Investigative SiteRecruiting
Seoul, 03722 · South Korea

Terms used on this page · explanations by MedicalUpdates.ai

Written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
legal representative: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
interventional: A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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