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NCT Number: NCT07517250

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

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.

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Key information

Conditions

Familial Mediterranean Fever Adult-Onset Still Disease Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Still Disease Still's Disease, Adult-Onset Systemic Juvenile Idiopathic Arthritis

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

    Time frame: Up to 3 years

  2. Percentage of Patients With Partial Remission Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

    Time frame: Up to 3 years

    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.

  3. Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

    Time frame: Up to 3 years

    Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.

  4. Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

    Time frame: Up to 3 years

    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.

  5. Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

    Time frame: Up to 3 years

    Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission.

  6. Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab

    Time frame: Up to 3 years

    Clinically inactive disease is defined as no active clinical symptoms, normal acute phase reactants, and normal disease activity scores.

  7. Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab

    Time frame: Up to 3 years

    Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.

  8. Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids

    Time frame: Up to 3 years

  9. Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation

    Time frame: 6 months

Secondary outcomes

  1. Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment

    Time frame: Up to 3 years

  2. Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment

    Time frame: Up to 3 years

  3. Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab

    Time frame: Up to 3 years

  4. Time to Switch From Anakinra or Tocilizumab to Canakinumab

    Time frame: Up to 3 years

  5. Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment

    Time frame: Up to 3 years

  6. Percentage of Patients by Dosing Regimen

    Time frame: Up to 3 years

  7. Time From Disease Onset to Prescription of First Biologic Treatment

    Time frame: Up to 3 years

  8. Time From Diagnosis to Prescription of First Biologic Treatment

    Time frame: Up to 3 years

  9. Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment

    Time frame: 12 months

  10. Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment

    Time frame: Up to 3 years

  11. Percentage of Patients With Hospitalizations Before Canakinumab Treatment

    Time frame: 12 months

    Hospitalizations include emergency room visits and hospital admissions.

  12. Percentage of Patients With Hospitalizations During Canakinumab Treatment

    Time frame: Up to 3 years

    Hospitalizations include emergency room visits and hospital admissions.

  13. Number of Hospitalizations Per Year Before Canakinumab Treatment

    Time frame: 12 months

    Hospitalizations include emergency room visits and hospital admissions.

  14. Number of Hospitalizations Per Year During Canakinumab Treatment

    Time frame: Up to 3 years

    Hospitalizations include emergency room visits and hospital admissions.

  15. Total Length of Hospital Stay Per Year Before Canakinumab Treatment

    Time frame: 12 months

    Hospital stays include general ward and intensive care unit.

  16. Total Length of Hospital Stay Per Year During Canakinumab Treatment

    Time frame: Up to 3 years

    Hospital stays include general ward and intensive care unit.

  17. Percentage of Patients With Medical Visits Before Canakinumab Treatment

    Time frame: 12 months

    Percentage of patients with medical visits, stratified by physician specialty.

  18. Percentage of Patients With Medical Visits During Canakinumab Treatment

    Time frame: Up to 3 years

    Percentage of patients with medical visits, stratified by physician specialty.

  19. Number of Medical Visits Per Year Before Canakinumab Treatment

    Time frame: 12 months

    Number of medical visits per year, stratified by physician specialty.

  20. Number of Medical Visits Per Year During Canakinumab Treatment

    Time frame: Up to 3 years

    Number of medical visits per year, stratified by physician specialty.

  21. Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment

    Time frame: 12 months

    Percentage of patients with diagnostic tests, stratified by type of test.

  22. Percentage of Patients With Diagnostic Tests During Canakinumab Treatment

    Time frame: Up to 3 years

    Percentage of patients with diagnostic tests, stratified by type of test.

  23. Number of Diagnostic Tests Per Year Before Canakinumab Treatment

    Time frame: 12 months

    Number of diagnostic tests per year, stratified by type of test.

  24. Number of Diagnostic Tests Per Year During Canakinumab Treatment

    Time frame: Up to 3 years

    Number of diagnostic tests per year, stratified by type of test.

  25. Percentage of Patients With Laboratory Tests Before Canakinumab Treatment

    Time frame: 12 months

    Percentage of patients with laboratory tests, stratified by type of test.

  26. Percentage of Patients With Laboratory Tests During Canakinumab Treatment

    Time frame: Up to 3 years

    Percentage of patients with laboratory tests, stratified by type of test.

  27. Number of Laboratory Tests Per Year Before Canakinumab Treatment

    Time frame: 12 months

    Number of laboratory tests per year, stratified by type of test.

  28. Number of Laboratory Tests Per Year During Canakinumab Treatment

    Time frame: Up to 3 years

    Number of laboratory tests per year, stratified by type of test.

  29. Quality of Life Scale Score

    Time frame: Up to 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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