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 Type
OBSERVATIONAL
Enrollment
160
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
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.
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
Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.
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
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.
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
Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission.
Time frame: 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.
Time frame: 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.
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
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
Hospitalizations include emergency room visits and hospital admissions.
Time frame: 12 months
Percentage of Patients With Hospitalizations During Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Time frame: Up to 3 years
Number of Hospitalizations Per Year Before Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Time frame: 12 months
Number of Hospitalizations Per Year During Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Time frame: Up to 3 years
Total Length of Hospital Stay Per Year Before Canakinumab Treatment
Hospital stays include general ward and intensive care unit.
Time frame: 12 months
Total Length of Hospital Stay Per Year During Canakinumab Treatment
Hospital stays include general ward and intensive care unit.
Time frame: Up to 3 years
Percentage of Patients With Medical Visits Before Canakinumab Treatment
Percentage of patients with medical visits, stratified by physician specialty.
Time frame: 12 months
Percentage of Patients With Medical Visits During Canakinumab Treatment
Percentage of patients with medical visits, stratified by physician specialty.
Time frame: Up to 3 years
Number of Medical Visits Per Year Before Canakinumab Treatment
Number of medical visits per year, stratified by physician specialty.
Time frame: 12 months
Number of Medical Visits Per Year During Canakinumab Treatment
Number of medical visits per year, stratified by physician specialty.
Time frame: Up to 3 years
Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment
Percentage of patients with diagnostic tests, stratified by type of test.
Time frame: 12 months
Percentage of Patients With Diagnostic Tests During Canakinumab Treatment
Percentage of patients with diagnostic tests, stratified by type of test.
Time frame: Up to 3 years
Number of Diagnostic Tests Per Year Before Canakinumab Treatment
Number of diagnostic tests per year, stratified by type of test.
Time frame: 12 months
Number of Diagnostic Tests Per Year During Canakinumab Treatment
Number of diagnostic tests per year, stratified by type of test.
Time frame: Up to 3 years
Percentage of Patients With Laboratory Tests Before Canakinumab Treatment
Percentage of patients with laboratory tests, stratified by type of test.
Time frame: 12 months
Percentage of Patients With Laboratory Tests During Canakinumab Treatment
Percentage of patients with laboratory tests, stratified by type of test.
Time frame: Up to 3 years
Number of Laboratory Tests Per Year Before Canakinumab Treatment
Number of laboratory tests per year, stratified by type of test.
Time frame: 12 months
Number of Laboratory Tests Per Year During Canakinumab Treatment
Number of laboratory tests per year, stratified by type of test.
Time frame: 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.
Time frame: Up to 3 years
Novartis Pharmaceuticals
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