Actively Recruiting

Age: 1Year +
All Genders
ID07517250

Non-interventional Study on the Use of ILARIS4 (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel

Led by Novartis Pharmaceuticals · Updated on 2026-05-22

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the treatment patterns, 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). This observational study focuses on patients who have received canakinumab treatment for at least six months to understand its use in real-world settings across Europe and Israel. The study includes three groups of patients: those with FMF, SJIA, and AOSD, all of whom have been treated with canakinumab for at least six months. It tracks treatment use and responses over time, including the use of other biologic agents like anakinra and tocilizumab. The research assesses various outcomes up to three years after starting canakinumab, including disease activity, remission status, steroid usage, treatment switches, hospitalizations, medical visits, and quality of life. Participants' medical records and data will be reviewed for clinical characteristics, treatments, hospitalizations, diagnostic and laboratory tests, and quality of life measures over a follow-up period of up to three years. The study aims to measure how many patients achieve inactive disease or remission and track other treatment responses. Data collection includes information before, during, and after canakinumab treatment to provide a comprehensive understanding of patient outcomes and long-term management.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric or adult patients prescribed canakinumab before October 2021
  • Received canakinumab for at least 6 months for FMF or Still's disease (including SJIA or AOSD)
  • Have clinical characteristic and treatment data available for at least 3 years after starting canakinumab treatment
Not Eligible

You will not qualify if you...

  • Patients younger than 2 years (24 months) at the index date

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 years

Participants who have received canakinumab for at least 6 months are observed for clinical outcomes and treatment patterns over time.

Visits as per routine clinical care over up to 3 years

Trial Site Locations

Total: 1 location

1

Novartis

Basel, Switzerland, CH-4056

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

N

Novartis Pharmaceuticals

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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