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A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
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.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 2961 |
| Start date | Tue Mar 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Aug 31 2031 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Multiple Sclerosis
Interventions
- Ozanimod
- Select DMTs other than ozanimod
- No DMTs
Countries
United States