NCT01213641已完成不适用
An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- To monitor and further explore the overall safey of canakinumab focusing in serious infections
研究概览
简要总结
The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical care
排除标准
- •Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To monitor and further explore the overall safey of canakinumab focusing in serious infections
时间窗: At least 5 years
次要结局
- Identify previously unrecognized serious adverse drug reactions in the treated population(at least 5 years)
- Usage and patterns of dosing of Ilaris in routine clinical practice(at least 5 years)
- Incidence of serious infections(at least 5 years)
- Incidence of hypersensitivity reactions(at least 5 years)
- Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness)(At least 5 years)
- Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris(at least 5 years)
- Incidence of malignancies(at least 5 years)
研究者
研究点 (4)
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