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A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis 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 ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
Official title: Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
Key Details
Gender
FEMALE
Age Range
18 Years - 49 Years
Study Type
OBSERVATIONAL
Enrollment
2828
Start Date
2024-08-26
Completion Date
2032-06-30
Last Updated
2024-10-01
Healthy Volunteers
No
Conditions
Interventions
Ozanimod
Women with UC exposed to ozanimod during pregnancy
Conventional therapy
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
Advanced therapy
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
Locations (1)
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States