A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Not yet recruiting
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT05953402
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1182
Inclusion Criteria
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Exclusion Criteria
- Exposure to other S1P therapies at any time during pregnancy
Other protocol-defined eligibility criteria apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event rate of Major Congenital Malformations (MCM) Up to 12 months
- Secondary Outcome Measures
Name Time Method Event rate of stillbirth Up to 9 months Event rate of neonatal death Up to 1 month Event rate of infant death Up to 12 months Event rate of preterm birth Up to 9 months Event rate of pre-eclampsia Up to 9 months Event rate of serious or opportunistic infant infections Up to 12 months Event rate of minor congenital malformations Up to 12 months Event rate of eclampsia Up to 9 months Event rate of Spontaneous Abortion (SAB) Up to 9 months Event rate of elective termination Up to 9 months Event rate of postnatal growth deficiency Up to 12 months Event rate of perinatal death Up to 10 months Event rate of Small for Gestational Age (SGA) Up to 12 months Event rate of infant developmental deficiency Up to 12 months