BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 728
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Major Congenital Malformations (MCMs)
研究概览
简要总结
The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
- •For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
- •Diagnosis of MS.
- •Currently or recently (within 1 year of pregnancy outcome) pregnant.
- •Authorization from healthcare provider to provide data to registry.
排除标准
- •Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
- •Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
- •Exposure to known teratogens and/or investigational medications during pregnancy.
研究组 & 干预措施
BRIUMVI® Unexposed Cohort
Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
干预措施: No intervention (Other)
BRIUMVI® Exposed Cohort
Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception [DOC]).
干预措施: No intervention (Other)
结局指标
主要结局
Percentage of Participants with Major Congenital Malformations (MCMs)
时间窗: Up to 52 weeks post-delivery
次要结局
未报告次要终点