A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Risk of major congenital malformations (MCM)
研究概览
简要总结
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
详细描述
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for EXPOSED SOURCE POPULATION:
- •Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- •Women diagnosed with SLE before pregnancy
- •Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2
排除标准
- •for EXPOSED SOURCE POPULATION:
- •- Pregnancies whose date of conception cannot be established
- •Inclusion criteria for UNEXPOSED SOURCE POPULATION:
- •Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- •Women diagnosed with SLE before pregnancy
- •Women treated with SLE SOC during pregnancy
- •Exclusion criteria for UNEXPOSED SOURCE POPULATION:
- •Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
- •Pregnancies whose date of conception cannot be established
- •Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- •- Women with moderate/severe SLE
- •Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- •Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
- •Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy
研究组 & 干预措施
Exposed cohort
Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
Unexposed cohort
Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE
结局指标
主要结局
Risk of major congenital malformations (MCM)
时间窗: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Relative risk of MCM
时间窗: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Risk of select pregnancy loss outcomes
时间窗: At delivery/birth
Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Relative risk of select pregnancy loss outcomes
时间窗: At delivery/birth
Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
次要结局
- Risk of minor congenital malformations (mCM)(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Relative risk of mCM(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Risk of adverse birth outcomes(At delivery/birth)
- Demographic and clinical characteristics(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Risk of adverse pregnancy outcomes(At delivery/birth)
- Relative risk of adverse pregnancy outcomes(At delivery/birth)
- Relative risk of adverse birth outcomes(At delivery/birth)