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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
• Patients Aged <2 Years (24 Months) at Index Date.
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Pediatric and adult patients prescribed canakinumab for at least 6 months for the treatment of FMF or Still's disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Recruiting | Basel | Switzerland |
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| ID | Term |
|---|---|
| D010505 | Familial Mediterranean Fever |
| D001171 | Arthritis, Juvenile |
| D016706 | Still's Disease, Adult-Onset |
| ID | Term |
|---|---|
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001168 | Arthritis |
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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 |
| 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 |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001172 | Arthritis, Rheumatoid |