NCT01357668进行中(未招募)不适用
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Bristol-Myers Squibb59 个研究点 分布在 22 个国家目标入组 800 人开始时间: 2013年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 800
- 试验地点
- 59
- 主要终点
- Incidence rate of autoimmune disorders
研究概览
简要总结
The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence rate of autoimmune disorders
时间窗: 10 years
Incidence rate of serious infections
时间窗: 10 years
Incidence rate of malignancies
时间窗: 10 years
次要结局
- Number of serious adverse events(10 years)
- Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)(10 years)
研究者
研究点 (59)
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