NCT06627335招募中不适用
Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,621
- 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 study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 14 years or older at pregnancy outcome.
- •Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP
- •At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
- •A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
- •Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
- •For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.
排除标准
- •One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
研究组 & 干预措施
Infants of women with AD exposed to ruxolitinib cream during pregnancy
干预措施: Ruxolitinib Cream (Drug)
Infants of women with AD exposed to a TCS prior to or during pregnancy
干预措施: TCS (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
- Number of small-for-gestational age (SGA) births(At time of delivery)
- Number of Pregnancy outcomes(Up to birth)
研究者
研究点 (1)
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