Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,961
- 试验地点
- 1
- 主要终点
- Prevalence of major congenital malformations among infants
研究概览
简要总结
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 49 years at date of conception
- •Date of conception between April 1, 2020 and July 31, 2030
排除标准
- •Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
- •Exposure to the DMTs fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester
研究组 & 干预措施
Ozanimod exposed
干预措施: Ozanimod (Drug)
Other DMT exposed
干预措施: Select DMTs other than ozanimod (Drug)
Not DMT exposed
干预措施: No DMTs (Drug)
结局指标
主要结局
Prevalence of major congenital malformations among infants
时间窗: Up to 11 years
Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed)
次要结局
- Number of spontaneous abortions(Up to 11 years)
- Number of preterm births(Up to 11 years)
- Number of stillbirths(Up to 11 years)
- Number of participants with pre-eclampsia(Up to 11 years)
- Number of participants with eclampsia(Up to 11 years)
- Number of infants small for gestational age(Up to 11 years)
- Number of serious or opportunistic infections in liveborn infants up to one year of age(Up to 11 years)
- Number of infant postnatal growth deficiencies(Up to 11 years)
- Number of infant developmental deficiencies(Up to 11 years)
- Number of neonatal hospitalizations(Up to 11 years)
- Number of infant deaths(Up to 11 years)
- Number of neonatal deaths(Up to 11 years)
- Number of perinatal deaths(Up to 11 years)