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Recruiting NCT07517250

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

— Observational Familial Mediterranean Fever Still Disease Systemic Juvenile Idiopathic Arthritis Adult-Onset Still Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease. Basic parameters: from 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab [Time frame: Up to 3 years]
  • Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab [Time frame: Up to 3 years]
  • Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids [Time frame: Up to 3 years]
  • Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation [Time frame: 6 months]
Secondary outcome measures (12)
  • Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment [Time frame: Up to 3 years]
  • Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment [Time frame: Up to 3 years]
  • Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab [Time frame: Up to 3 years]
  • Time to Switch From Anakinra or Tocilizumab to Canakinumab [Time frame: Up to 3 years]
  • Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment [Time frame: Up to 3 years]
  • Percentage of Patients by Dosing Regimen [Time frame: Up to 3 years]
  • Time From Disease Onset to Prescription of First Biologic Treatment [Time frame: Up to 3 years]
  • Time From Diagnosis to Prescription of First Biologic Treatment [Time frame: Up to 3 years]
  • Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment [Time frame: 12 months]
  • Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment [Time frame: Up to 3 years]
  • Percentage of Patients With Hospitalizations Before Canakinumab Treatment [Time frame: 12 months]
  • Percentage of Patients With Hospitalizations During Canakinumab Treatment [Time frame: Up to 3 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Novartis — Basel

Identifiers

NCT: NCT07517250 · CACZ885G2005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗