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A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
Sponsor: Bristol-Myers Squibb
Summary
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.
Official title: Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Key Details
Gender
FEMALE
Age Range
18 Years - 49 Years
Study Type
OBSERVATIONAL
Enrollment
2961
Start Date
2021-03-16
Completion Date
2031-08-31
Last Updated
2023-11-15
Healthy Volunteers
No
Conditions
Interventions
Ozanimod
Women with MS who were exposed to ozanimod during pregnancy
Select DMTs other than ozanimod
Women with MS exposed to select DMTs other than ozanimod during pregnancy
No DMTs
Women with MS not exposed to any DMTs during pregnancy
Locations (1)
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States