NCT05170126招募中不适用
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 1,182 人开始时间: 2022年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,182
- 试验地点
- 3
- 主要终点
- Major congenital malformations
研究概览
简要总结
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
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
- •Diagnosis of Multiple sclerosis (MS)
- •Currently or recently pregnant
- •Reside in the United States, Canada or Germany.
排除标准
- •Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Major congenital malformations
时间窗: Up to first year of life
次要结局
- Postnatal growth deficiency(Up to first year of life)
- Minor congenital malformations(Up to first year of life)
- Neonatal death(Up to first year of life)
- Serious or opportunistic infant infection (SOI)(Up to first year of life)
- Spontaneous abortion(Through pregnancy)
- Stillbirth(Through pregnancy)
- Preterm birth(Through pregnancy)
- Perinatal death(Up to first year of life)
- Pre-eclampsia(Through pregnancy)
- Eclampsia(Through pregnancy)
- Elective termination(Through pregnancy)
- Small for gestational age(Up to first year of life)
- Infant developmental deficiency(Up to first year of life)
- Infant death(Up to first year of life)
研究者
研究点 (3)
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