A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI).
研究概览
简要总结
The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). The study will be based on already available data from the Pharmachild juvenile idiopathic arthritis (JIA) registry which holds the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal.
详细描述
This is an international, non-interventional, single-armed, pharmacovigilance registry study on long-term safety of Kineret utilizing already available data from the ENCePP certified Pharmachild JIA registry.
The Paediatric Rheumatology International Trials Organisation (PRINTO) is a non-profit, non-governmental, international research network with the goal to foster, facilitate and co-ordinate the development, conduct, analysis, and reporting of multi-centers, international clinical trials and/or outcome standardization studies in children with paediatric rheumatic diseases.
The Pharmachild JIA registry, maintained by PRINTO, is a registry collecting data from patients with JIA including patients with SJIA. In the Pharmachild JIA registry 40 countries are participating of which 15 countries have collected data on Kineret treatment.
This study includes secondary use of data already available in the Pharmachild JIA registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a diagnosis of SJIA as per the International League of Associations for Rheumatology (ILAR) classification criteria
- •Included in the Pharmachild registry
- •Ever treated with Kineret subsequently to SJIA diagnosis
排除标准
- •No specific exclusion criteria will be applied.
研究组 & 干预措施
SJIA patients on Kineret treatment
SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry
干预措施: Anakinra (Drug)
结局指标
主要结局
The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI).
时间窗: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The occurrence of non-serious AEs of at least moderate severity and serious AEs (SAEs), including MAS as an ESI. AEs (SAEs), including MAS as an ESI.
The duration of Kineret treatment in a real-world setting.
时间窗: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The duration of Kineret treatment in a real-world setting.
The reasons for Kineret treatment discontinuation.
时间窗: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The reasons for Kineret treatment discontinuation.
次要结局
未报告次要终点