A US-Prospective, Registry-Based, Observational, Exposure Cohort Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 958
- 试验地点
- 1
- 主要终点
- Number of major congenital malformation (MCM)s
研究概览
简要总结
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.
详细描述
This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.
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
- •Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD.
- •Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent.
- •Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome).
- •Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort.
- •Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period.
- •Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period
- •Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up.
- •Permission to contact the participant's and her infant's HCPs.
排除标准
- •If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment.
- •Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study.
- •Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes.
研究组 & 干预措施
Infants of women exposed to ruxolitinib cream during pregnancy
干预措施: Ruxolitinib Cream (Drug)
Infants of women not exposed to ruxolitinib cream during pregnancy
干预措施: Ruxolitinib Cream (Drug)
结局指标
主要结局
Number of major congenital malformation (MCM)s
时间窗: Up to 12 months after birth
Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age.
次要结局
- Infant Head Circumference(Through 12 months after birth)
- Number of minor congenital malformations(Up to 12 months after birth)
- Number of Pregnancy outcomes(Up to birth)
- Adverse pregnancy outcomes(Up to birth)
- Gestational Age(At time of delivery)
- Infant Sex(At time of delivery)
- Infant Body Weight(Through 12 months after birth)
- Number of small for gestational age (SGA)s(At time of delivery)
- Abnormal development(Through 12 months after birth)
- Infant Body Length(Through 12 months after birth)
- APGAR Score(At time of delivery)