Ulcerative Colitis
Conditions
Keywords
ZEPOSIA®, Ozanimod, Pregnancy, Sphingosine-1-phosphate (S1P) therapies, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, UC
Brief summary
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event rate of Major Congenital Malformations (MCM) | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Event rate of minor congenital malformations | Up to 12 months |
| Event rate of pre-eclampsia | Up to 9 months |
| Event rate of eclampsia | Up to 9 months |
| Event rate of Spontaneous Abortion (SAB) | Up to 9 months |
| Event rate of stillbirth | Up to 9 months |
| Event rate of elective termination | Up to 9 months |
| Event rate of preterm birth | Up to 9 months |
| Event rate of Small for Gestational Age (SGA) | Up to 12 months |
| Event rate of postnatal growth deficiency | Up to 12 months |
| Event rate of infant developmental deficiency | Up to 12 months |
| Event rate of perinatal death | Up to 10 months |
| Event rate of neonatal death | Up to 1 month |
| Event rate of infant death | Up to 12 months |
| Event rate of serious or opportunistic infant infections | Up to 12 months |
Countries
United States
Contacts
CONTACTBMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACTFirst line of the email MUST contain the NCT# and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed