Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18-49 years
Brief 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 du...
Eligibility Criteria
Inclusion
- Women aged 18 to 49 years at date of conception
- Date of conception between April 1, 2020 and July 31, 2030
Exclusion
- 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
Key Trial Info
Start Date :
March 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2031
Estimated Enrollment :
2961 Patients enrolled
Trial Details
Trial ID
NCT06133049
Start Date
March 16 2021
End Date
August 31 2031
Last Update
November 15 2023
Active Locations (1)
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1
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States, 55344