Active, Not RecruitingN/ADMT
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
Sponsored by Bristol-Myers Squibb
NCT ID
NCT06133049
Target Enrollment
2,961 participants
Start Date
2021-03-16
Est. Completion
2031-08-31
About This Study
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.
Conditions Studied
Interventions
- •Ozanimod
- •Select DMTs other than ozanimod
- •No DMTs
Eligibility
Sex:FEMALE
Age:18 Years - 49 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Women aged 18 to 49 years at date of conception * Date of conception between April 1, 2020 and July 31, 2030 Exclusion Criteria: * 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
Study Locations (1)
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States