Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Major congenital malfunctions
研究概览
简要总结
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
详细描述
The anifrolumab PRIM program is a supplementary program which utilizes enhanced collection of secondary data from reported anifrolumab-exposed pregnancies collected as part of AstraZeneca's PV system.
Initial information about the exposed pregnancy will be collected through the pregnancy report submitted by anifrolumab treated patients or HCPs to the AstraZeneca PV database. Pregnancy outcome information will be collected in close proximity to the planned delivery. Additional follow-up and outcome information will be collected 12 months after delivery. For PV reports of exposed pregnancies that have already had a pregnancy outcome at the time of initial report (retrospective cases), initial characteristics, pregnancy outcome, and any available infant health information will be collected at the time of the initial report.
Targeted follow-up checklists and guidance documents will ensure that PV data collected for anifrolumab-exposed pregnancies are as complete as possible and have been mapped for pre-specified analytic variables that will be used to evaluate the safety of anifrolumab exposure for pregnancy and infant outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently or recently (within 1 year of pregnancy outcome) pregnant
- •Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception
排除标准
- •Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.
研究组 & 干预措施
Anifrolumab exposed pregnancies
The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.
干预措施: Anifrolumab (Drug)
结局指标
主要结局
Major congenital malfunctions
时间窗: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
The primary objective of the PRIM program is to estimate the proportion of anifrolumab-exposed pregnancies with major congenital malformations (MCMs) associated with exposure to anifrolumab during pregnancy.
次要结局
- Minor congenital malformations(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Adverse pregnancy outcomes(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Frequency of adverse pregnancy and birth outcomes(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)