Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring

IM047-025

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.

2024-08-01

2031-05-31

2031-05-31

Not yet recruiting

2828

Inclusion Criteria: * 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 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)

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 2828, 'type': 'ESTIMATED'}}

2024-05-02