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

N/ANot Yet RecruitingNCT05953402

Bristol-Myers Squibb1,182 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,182

Conditions

Ulcerative Colitis

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Event rate of Major Congenital Malformations (MCM)

Time frame: Up to 12 months

Secondary Outcomes

Event rate of minor congenital malformations

Time frame: Up to 12 months

Event rate of pre-eclampsia

Time frame: Up to 9 months

Event rate of eclampsia

Time frame: Up to 9 months

Event rate of Spontaneous Abortion (SAB)

Time frame: Up to 9 months

Event rate of stillbirth

Time frame: Up to 9 months

Event rate of elective termination

Time frame: Up to 9 months

Event rate of preterm birth

Time frame: Up to 9 months

Event rate of Small for Gestational Age (SGA)

Time frame: Up to 12 months

Event rate of postnatal growth deficiency

Time frame: Up to 12 months

Event rate of infant developmental deficiency

Time frame: Up to 12 months

Event rate of perinatal death

Time frame: Up to 10 months

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Data from ClinicalTrials.gov

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