Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients Aged <2 Years (24 Months) at Index Date.
研究组 & 干预措施
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.
结局指标
主要结局
Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 3 years
Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation
时间窗: 6 months
次要结局
- 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 Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment(Up to 3 years)
- Percentage of Patients With Hospitalizations Before Canakinumab Treatment(12 months)
- Percentage of Patients With Hospitalizations During Canakinumab Treatment(Up to 3 years)
- Number of Hospitalizations Per Year Before Canakinumab Treatment(12 months)
- Number of Hospitalizations Per Year During Canakinumab Treatment(Up to 3 years)
- Total Length of Hospital Stay Per Year Before Canakinumab Treatment(12 months)
- Total Length of Hospital Stay Per Year During Canakinumab Treatment(Up to 3 years)
- Percentage of Patients With Medical Visits Before Canakinumab Treatment(12 months)
- Percentage of Patients With Medical Visits During Canakinumab Treatment(Up to 3 years)
- Number of Medical Visits Per Year Before Canakinumab Treatment(12 months)
- Number of Medical Visits Per Year During Canakinumab Treatment(Up to 3 years)
- Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment(12 months)
- Percentage of Patients With Diagnostic Tests During Canakinumab Treatment(Up to 3 years)
- Number of Diagnostic Tests Per Year Before Canakinumab Treatment(12 months)
- Number of Diagnostic Tests Per Year During Canakinumab Treatment(Up to 3 years)
- Percentage of Patients With Laboratory Tests Before Canakinumab Treatment(12 months)
- Percentage of Patients With Laboratory Tests During Canakinumab Treatment(Up to 3 years)
- Number of Laboratory Tests Per Year Before Canakinumab Treatment(12 months)
- Number of Laboratory Tests Per Year During Canakinumab Treatment(Up to 3 years)
- Quality of Life Scale Score(Up to 3 years)