CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percent of live birth children with major congenital malformations
研究概览
简要总结
The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring.
The study is seeking participants who:
- Are currently or recently pregnant
- Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis
All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy.
The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy.
Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
- •Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- •Authorization for her healthcare provider(s) to provide data to the registry
- •Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.
排除标准
- •Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
研究组 & 干预措施
Exposed to CIBINQO during pregnancy
Received at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception).
干预措施: Abrocitinib (Drug)
结局指标
主要结局
Percent of live birth children with major congenital malformations
时间窗: Enrollment until 12 months after delivery
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.
次要结局
- Percent of participants with stillbirths(Enrollment until end of pregnancy (up to 9 months))
- Percentage of participants with children with postnatal growth deficiency(Enrollment until 12 months after delivery)
- Percent of participants with children with minor congenital malformations(Enrollment until 12 months after delivery)
- Percent of participants with spontaneous abortion(Enrollment until end of pregnancy (up to 20 gestational weeks))
- Percentage of participants with an elective termination(Enrollment until end of pregnancy (up to 9 months))
- Percent of participants with preterm birth(Enrollment until 12 months after delivery)
- Percent of participants with children born small for gestational age(Enrollment until 12 months after delivery)
- Percent of participants with infant developmental delay(Enrollment until 12 months after delivery)