Canakinumab use in FMF and Still's disease patients across real-world care
Official title: Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel
Run by Novartis · NCT07517250 · Data updated 2026-11-12
This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | canakinumab |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | December 3, 2026 |
| Study ends | December 3, 2026 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07517250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pediatric or adult patients diagnosed with FMF or Still's disease (including SJIA or AOSD) who started canakinumab and continued it for at least six months, with at least three years of follow-up data after initiation.
✕Probably not a fit
Patients who did not have at least six months of canakinumab treatment or who lack three years of follow-up data may not contribute to the primary analyses of outcomes.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study characterizes treatment patterns, long-term clinical outcomes, and patient demographics for individuals with FMF or Still's disease (including SJIA and AOSD) who received canakinumab for six months or longer. Data are drawn from real-world clinical use up to October 2021, with a minimum follow-up of three years post-treatment initiation. The analysis focuses on how canakinumab is used in routine practice and its associated outcomes and quality of life. No interventional procedures are mandated; the study relies on existing medical records to describe patterns and outcomes. The sponsor is Novartis, based in Basel, with no listed collaborators.
Why it matters
Potential benefit: If successful, the study could clarify long-term outcomes and help guide treatment decisions for people with FMF or Still's disease who are considering or already receiving canakinumab.
How similar studies have gone: There is prior real-world experience with canakinumab in autoinflammatory conditions, but this study adds breadth by including FMF and Still's disease cohorts together with SJIA and AOSD in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Novartis
Basel, Switzerland Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.