An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of newborns with Major Congenital Malformations (MCMs)
研究概览
简要总结
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.
详细描述
Acquired from Horizon in 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent
- •Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
- •Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception
- •Note: Other Protocol Defined Inclusion/
排除标准
- 未提供
结局指标
主要结局
Number of newborns with Major Congenital Malformations (MCMs)
时间窗: Minimum of 10 years
Number of stillbirths
时间窗: Minimum of 10 years
Number of newborns with low birth weight
时间窗: Minimum of 10 years
Number of newborns with Preterm birth
时间窗: Minimum of 10 years
次要结局
- Number of newborns with Minor Congenital Malformations(Minimum of 10 years)
- Number of infants with developmental milestone abnormalities(Minimum of 10 years)
- Number of infants with neurologic abnormalities(Minimum of 10 years)
- Number of Induced or Elective Abortions(Minimum of 10 years)
- Number of Spontaneous Abortions(Minimum of 10 years)
- Number of infants with immune system development abnormalities(Minimum of 10 years)