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NCT05953402 Clinical Trial

A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

Ulcerative Colitis Clinical Trial

Official title:
ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05953402
Other study ID # IM047-026
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 6, 2023
Est. completion date June 30, 2032

Study information
Verified date July 2023
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1182
Est. completion date June 30, 2032
Est. primary completion date June 30, 2032
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Outcome
Type Measure Description Time frame Safety issue
Primary Event rate of Major Congenital Malformations (MCM) Up to 12 months
Secondary Event rate of minor congenital malformations Up to 12 months
Secondary Event rate of pre-eclampsia Up to 9 months
Secondary Event rate of eclampsia Up to 9 months
Secondary Event rate of Spontaneous Abortion (SAB) Up to 9 months
Secondary Event rate of stillbirth Up to 9 months
Secondary Event rate of elective termination Up to 9 months
Secondary Event rate of preterm birth Up to 9 months
Secondary Event rate of Small for Gestational Age (SGA) Up to 12 months
Secondary Event rate of postnatal growth deficiency Up to 12 months
Secondary Event rate of infant developmental deficiency Up to 12 months
Secondary Event rate of perinatal death Up to 10 months
Secondary Event rate of neonatal death Up to 1 month
Secondary Event rate of infant death Up to 12 months
Secondary Event rate of serious or opportunistic infant infections Up to 12 months
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