ClinicalTrials.gov record NCT07517250

A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel

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 and older
SexAll
LocationSwitzerland
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 retrospective observational cohort study uses medical records to describe how canakinumab has been used in people with Familial Mediterranean Fever (FMF) or Still's disease (including SJIA and AOSD). It focuses on pediatric and adult patients who received canakinumab for at least six months and have follow-up data. The study will report treatment patterns, clinical response categories, steroid use changes, healthcare use, and quality-of-life scores when available.

What it is studying. The study collects existing clinical data to characterize treatment patterns and long-term clinical outcomes after canakinumab in FMF and Still's disease. It aims to measure proportions of patients with inactive disease, complete or partial responses, poor response, steroid tapering or discontinuation, reasons for stopping canakinumab, switching between biologic treatments, dosing regimens, hospitalizations, medical visits, diagnostic and laboratory testing, and quality-of-life scores when present in records.

What the researchers hope to learn. To describe real-world treatment patterns and patient characteristics among people with FMF and Still's disease treated with canakinumab; to estimate rates of clinical inactive disease, complete and partial responses, steroid tapering, treatment switches and discontinuations, healthcare use (hospitalizations and visits), dosing patterns, and available quality-of-life scores.

What this study is about

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

This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis [SJIA] and adult-onset Still's disease [AOSD]) that received canakinumab for at least 6 months.

Eligibility

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

Inclusion criteria

  • Pediatric or adult patients who were prescribed canakinumab before October 2021 and received canakinumab for at least 6 months for the treatment of FMF or Still's disease (including SJIA or AOSD).
  • Have data on clinical characteristics and treatments available for at least 3 years following the initiation of canakinumab treatment.

Exclusion criteria

  • Patients Aged <2 Years (24 Months) at Index Date.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

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.

Researchers will review existing medical records from the time canakinumab was started and collect information on treatments, disease activity, hospital visits, diagnostic and laboratory tests, dosing regimens, steroid use, and any recorded quality-of-life scores. The analysis focuses on the period up to about three years after canakinumab initiation. This is a retrospective observational study using past medical data; the study does not assign treatments.

How the study is structured. A retrospective observational cohort study that reviews medical records. No new treatments are given; patients are grouped by diagnosis (FMF, SJIA, AOSD) and followed in the records for up to three years after starting canakinumab to collect outcomes and care patterns.

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 Switzerland. 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 adult-onset Still's disease

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

Clinical trials13 trials listed for adult-onset Still's diseaseEvery trial the registry lists for adult-onset Still's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in adult-onset Still's disease researchLatest monthly update: September 2026. Includes: MAS initial treatment. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 15, 2026
Primary completion
Dec 3, 2026 (estimated)
Study completion
Dec 3, 2026 (estimated)
Target enrollment
160 participants (estimated)
Last updated on registry
Jun 9, 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.

Participating sites (1)

  • NovartisRecruiting

    Basel · Switzerland

Terms used on this page · explanations by MedicalUpdates.ai

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.

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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