A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Treatments: Drug: Ozanimod; Drug: Conventional therapy; Drug: Advanced therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06126835

IM047-025

Details and patient eligibility

About

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.

Enrollment: 2,828 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,828 participants in 3 patient groups

Ozanimod exposed

Treatment:

Drug: Ozanimod

Conventional therapy exposed

Treatment:

Drug: Conventional therapy

Advanced therapy exposed

Treatment:

Drug: Advanced therapy