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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Familial Mediterranean Fever; Systemic Juvenile Idiopathic Arthritis; Still Disease; Adult-Onset Still Disease

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4056
    • Recruiting
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric and adult patients prescribed canakinumab for at least 6 months for the treatment of FMF or Still's disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
FMF Cohort; Patients diagnosed with FMF that received canakinumab for at least 6 months.
SJIA Cohort; Patients diagnosed with SJIA that received canakinumab for at least 6 months.
AOSD Cohort; Patients diagnosed with AOSD that received canakinumab for at least 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents		Up to 3 years
Percentage of Patients With Partial Remission Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents	Partial remission is defined as a significant clinical and laboratory improvement according to the attending physician's opinion or clinical remission with remaining laboratory activity.	Up to 3 years
Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents	Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.	Up to 3 years
Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents	Partial response is defined as persistence of clinical manifestations with remarkable decrease in their severity and/or inflammatory laboratory parameters normalized or only slightly increased.	Up to 3 years
Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents	Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission.	Up to 3 years
Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab	Clinically inactive disease is defined as no active clinical symptoms, normal acute phase reactants, and normal disease activity scores.	Up to 3 years
Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab	Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.	Up to 3 years
Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids		Up to 3 years
Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment		Up to 3 years
Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment		Up to 3 years
Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab		Up to 3 years
Time to Switch From Anakinra or Tocilizumab to Canakinumab		Up to 3 years
Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment		Up to 3 years
Percentage of Patients by Dosing Regimen		Up to 3 years
Time From Disease Onset to Prescription of First Biologic Treatment		Up to 3 years
Time From Diagnosis to Prescription of First Biologic Treatment		Up to 3 years
Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment		12 months
Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment		Up to 3 years
Percentage of Patients With Hospitalizations Before Canakinumab Treatment	Hospitalizations include emergency room visits and hospital admissions.	12 months
Percentage of Patients With Hospitalizations During Canakinumab Treatment	Hospitalizations include emergency room visits and hospital admissions.	Up to 3 years
Number of Hospitalizations Per Year Before Canakinumab Treatment	Hospitalizations include emergency room visits and hospital admissions.	12 months
Number of Hospitalizations Per Year During Canakinumab Treatment	Hospitalizations include emergency room visits and hospital admissions.	Up to 3 years
Total Length of Hospital Stay Per Year Before Canakinumab Treatment	Hospital stays include general ward and intensive care unit.	12 months
Total Length of Hospital Stay Per Year During Canakinumab Treatment	Hospital stays include general ward and intensive care unit.	Up to 3 years
Percentage of Patients With Medical Visits Before Canakinumab Treatment	Percentage of patients with medical visits, stratified by physician specialty.	12 months
Percentage of Patients With Medical Visits During Canakinumab Treatment	Percentage of patients with medical visits, stratified by physician specialty.	Up to 3 years
Number of Medical Visits Per Year Before Canakinumab Treatment	Number of medical visits per year, stratified by physician specialty.	12 months
Number of Medical Visits Per Year During Canakinumab Treatment	Number of medical visits per year, stratified by physician specialty.	Up to 3 years
Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment	Percentage of patients with diagnostic tests, stratified by type of test.	12 months
Percentage of Patients With Diagnostic Tests During Canakinumab Treatment	Percentage of patients with diagnostic tests, stratified by type of test.	Up to 3 years
Number of Diagnostic Tests Per Year Before Canakinumab Treatment	Number of diagnostic tests per year, stratified by type of test.	12 months
Number of Diagnostic Tests Per Year During Canakinumab Treatment	Number of diagnostic tests per year, stratified by type of test.	Up to 3 years
Percentage of Patients With Laboratory Tests Before Canakinumab Treatment	Percentage of patients with laboratory tests, stratified by type of test.	12 months
Percentage of Patients With Laboratory Tests During Canakinumab Treatment	Percentage of patients with laboratory tests, stratified by type of test.	Up to 3 years
Number of Laboratory Tests Per Year Before Canakinumab Treatment	Number of laboratory tests per year, stratified by type of test.	12 months
Number of Laboratory Tests Per Year During Canakinumab Treatment	Number of laboratory tests per year, stratified by type of test.	Up to 3 years
Quality of Life Scale Score	This analysis will be done if a minimum of 30 patients with the same patient-reported outcome (PRO) and same version are available in the medical charts.	Up to 3 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Canakinumab; Clinical outcomes; Treatment patterns; Patient quality of life; Real-world evidence study; Pediatric and adult patients
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid; Hereditary Autoinflammatory Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Familial Mediterranean Fever; Still's Disease, Adult-Onset
• Other Study ID Numbers: CACZ885G2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO