Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Ulcerative Colitis
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 ulcerative colitis (UC) who were exposed to ozanimod du...
Eligibility Criteria
Inclusion
- Age 18 to 49 years on date of conception
- Date of conception between June 1, 2021 and September 1, 2030
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
- Diagnosis of UC during the 12 months prior to conception through the end of the first trimester
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)
Key Trial Info
Start Date :
August 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
2828 Patients enrolled
Trial Details
Trial ID
NCT06126835
Start Date
August 26 2024
End Date
June 30 2032
Last Update
October 1 2024
Active Locations (1)
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1
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States, 55344