NCT05953402尚未招募不适用
ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
Bristol-Myers Squibb0 个研究点目标入组 1,182 人开始时间: 2025年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,182
- 主要终点
- Event rate of Major Congenital Malformations (MCM)
研究概览
简要总结
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
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
- •Currently or recently pregnant
- •Diagnosis of UC
- •Resident of country where ozanimod is prescribed for the treatment of UC
排除标准
- •Exposure to other S1P therapies at any time during pregnancy
- •Other protocol-defined eligibility criteria apply.
结局指标
主要结局
Event rate of Major Congenital Malformations (MCM)
时间窗: Up to 12 months
次要结局
- Event rate of Small for Gestational Age (SGA)(Up to 12 months)
- Event rate of infant developmental deficiency(Up to 12 months)
- Event rate of preterm birth(Up to 9 months)
- Event rate of neonatal death(Up to 1 month)
- Event rate of infant death(Up to 12 months)
- Event rate of pre-eclampsia(Up to 9 months)
- Event rate of serious or opportunistic infant infections(Up to 12 months)
- Event rate of minor congenital malformations(Up to 12 months)
- Event rate of eclampsia(Up to 9 months)
- Event rate of stillbirth(Up to 9 months)
- Event rate of perinatal death(Up to 10 months)
- Event rate of Spontaneous Abortion (SAB)(Up to 9 months)
- Event rate of elective termination(Up to 9 months)
- Event rate of postnatal growth deficiency(Up to 12 months)
研究者
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