Adult-Onset Still Disease, Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis
Conditions
Keywords
Canakinumab, Real-world evidence study, Treatment patterns, Clinical outcomes, Patient quality of life, Pediatric and adult patients
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents | 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. |
| Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents | 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. |
| Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents | Up to 3 years | Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission. |
| Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab | Up to 3 years | Clinically inactive disease is defined as no active clinical symptoms, normal acute phase reactants, and normal disease activity scores. |
| Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months | Hospitalizations include emergency room visits and hospital admissions. |
| Percentage of Patients With Hospitalizations During Canakinumab Treatment | Up to 3 years | Hospitalizations include emergency room visits and hospital admissions. |
| Number of Hospitalizations Per Year Before Canakinumab Treatment | 12 months | Hospitalizations include emergency room visits and hospital admissions. |
| Number of Hospitalizations Per Year During Canakinumab Treatment | Up to 3 years | Hospitalizations include emergency room visits and hospital admissions. |
| Total Length of Hospital Stay Per Year Before Canakinumab Treatment | 12 months | Hospital stays include general ward and intensive care unit. |
| Total Length of Hospital Stay Per Year During Canakinumab Treatment | Up to 3 years | Hospital stays include general ward and intensive care unit. |
| Percentage of Patients With Medical Visits Before Canakinumab Treatment | 12 months | Percentage of patients with medical visits, stratified by physician specialty. |
| Percentage of Patients With Medical Visits During Canakinumab Treatment | Up to 3 years | Percentage of patients with medical visits, stratified by physician specialty. |
| Number of Medical Visits Per Year Before Canakinumab Treatment | 12 months | Number of medical visits per year, stratified by physician specialty. |
| Number of Medical Visits Per Year During Canakinumab Treatment | Up to 3 years | Number of medical visits per year, stratified by physician specialty. |
| Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment | 12 months | Percentage of patients with diagnostic tests, stratified by type of test. |
| Percentage of Patients With Diagnostic Tests During Canakinumab Treatment | Up to 3 years | Percentage of patients with diagnostic tests, stratified by type of test. |
| Number of Diagnostic Tests Per Year Before Canakinumab Treatment | 12 months | Number of diagnostic tests per year, stratified by type of test. |
| Number of Diagnostic Tests Per Year During Canakinumab Treatment | Up to 3 years | Number of diagnostic tests per year, stratified by type of test. |
| Percentage of Patients With Laboratory Tests Before Canakinumab Treatment | 12 months | Percentage of patients with laboratory tests, stratified by type of test. |
| Percentage of Patients With Laboratory Tests During Canakinumab Treatment | Up to 3 years | Percentage of patients with laboratory tests, stratified by type of test. |
| Number of Laboratory Tests Per Year Before Canakinumab Treatment | 12 months | Number of laboratory tests per year, stratified by type of test. |
| Number of Laboratory Tests Per Year During Canakinumab Treatment | Up to 3 years | Number of laboratory tests per year, stratified by type of test. |
| Quality of Life Scale Score | 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. |
Countries
Switzerland
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed