NCT02326376已完成不适用
Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe
Swedish Orphan Biovitrum1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年4月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rate of injection site reactions
研究概览
简要总结
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.
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
- •Informed consent by the patient and/or caregiver
- •Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator
排除标准
- 未提供
研究组 & 干预措施
CAPS patients
CAPS patients treated with anakinra, using the Kineret graduated syringe
干预措施: anakinra (Kineret) (Drug)
结局指标
主要结局
Rate of injection site reactions
时间窗: 3 years
Rate of allergic reactions
时间窗: 3 years
Rate of serious infections
时间窗: 3 years
Rate of new malignancies
时间窗: 3 years
Rate of medication errors including re-use of syringe
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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