PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Composite outcome of all major congenital malformations (MCMs)
研究概览
简要总结
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.
详细描述
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a US-based, prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. The objective of the pregnancy registry is to compare adverse maternal, fetal, and infant outcomes of pregnant individuals with moderate/severe systemic lupus erythematosus (SLE) who are exposed to anifrolumab during pregnancy with outcomes in an internal comparison cohort of pregnant individuals with moderate/severe SLE who are not exposed to anifrolumab during pregnancy. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. The study is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during medical care will be actively collected. No additional laboratory tests or HCP assessments will be required as part of this registry. This study will fulfil an FDA post-marketing requirement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Exposed cohort
- •Currently or recently (within 1 year of pregnancy outcome) pregnant
- •Diagnosis of moderate/severe SLE
- •Consent to participate
- •Authorization for their HCP(s) to provide data to the registry
- •Exposure to at least 1 dose of anifrolumab at any time during pregnancy
- •Unexposed cohort
- •Currently or recently pregnant
- •Diagnosis of moderate/severe SLE
- •Consent to participate
- •Authorization for their HCP(s) to provide data to the registry
- •Exposure to other products for the treatment of moderate/severe SLE
排除标准
- •Exposed cohort
- •Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
- •Exposure to known teratogens and/or investigational medications during pregnancy
- •Unexposed cohort
- •Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
- •Exposure to known teratogens and/or investigational medications during pregnancy
研究组 & 干预措施
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
Exposed cohort
Pregnant individuals with a diagnosis of moderate/severe SLE who are exposed to anifrolumab at any time during pregnancy
干预措施: Anifrolumab (Drug)
结局指标
主要结局
Composite outcome of all major congenital malformations (MCMs)
时间窗: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Relevant exposure window is limited to 1st trimester of pregnancy.
次要结局
- Composite outcome of all minor congenital malformations(From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births)
- Worsening of underlying disease(From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy)
- Premature rupture of membranes(From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy)
- Pregnancy-induced hypertension(From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy)
- Composite outcome of preeclampsia/eclampsia(From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy)
- Maternal hospitalization for serious illness(From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy)
- Elective termination(From date of conception (DOC) to pregnancy outcome, up to 24 weeks of pregnancy)
- Spontaneous abortion(From date of conception (DOC) to <20 gestational weeks)
- Emergency caesarean section(From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy)
- Preterm birth(From date of conception (DOC) up to 37 gestational weeks)
- Small for gestational age(At delivery of live birth)
- Postnatal growth deficiency(At 4 and 12 months of infant age)
- Infant developmental delay(At 4 and 12 months of infant age)
- Infant hospitalization for serious illness(From birth to 1 year of infant age)
- Infant serious or opportunistic infection(From birth to 1 year of infant age)