jRCT2051210017进行中（未招募）不适用
An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has completed at least 2 years in the OLP of Study CD-IA-MEDI-551-1155, and has not discontinued inebilizumab treatment in that study
- •Is deemed eligible to continue receiving inebilizumab by the Investigator
排除标准
- •Has any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of patient safety or study results
- •Lactating or pregnant females, or females who intend to become pregnant after signing the informed consent
结局指标
主要结局
safety
characterize the effects of long term inebilizumab treatment on safety
laboratory
characterize the effects of long term inebilizumab treatment on laboratory
recovery of particular laboratory measures
monitor recovery of particular laboratory measures following discontinuation of inebilizumab
other measures
characterize the effects of long term inebilizumab treatment on other measures
次要结局
未报告次要终点
研究者
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