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

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Ozanimod; Drug: Conventional therapy; Drug: Advanced therapy

• Registration Number: NCT06126835
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Study Start: 2024-08-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2031-05-31
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2828

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ozanimod exposed	Ozanimod	-
Conventional therapy exposed	Conventional therapy	-
Advanced therapy exposed	Advanced therapy	-

Primary Outcome Measures

Name	Time	Method
Prevalence of major congenital malformations among infants	Up to 10 years	To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.

Secondary Outcome Measures

Name	Time	Method
Number of spontaneous abortions	Up to 10 years
Number of participants with pre-eclampsia	Up to 10 years
Number of preterm births	Up to 10 years
Number of infants small for gestational age	Up to 10 years
Number of infant postnatal growth deficiencies	Up to 10 years
Number of infant developmental deficiencies	Up to 10 years
Number of neonatal hospitalizations	Up to 10 years
Number of participants with eclampsia	Up to 10 years
Number of serious or opportunistic infections in liveborn infants up to 1 year of age	Up to 10 years
Number of stillbirths	Up to 10 years
Number of infant deaths	Up to 10 years
Number of neonatal deaths	Up to 10 years
Number of perinatal deaths	Up to 10 years

Trial Locations

Locations (1)

OptumInsight Life Sciences Inc; 🇺🇸 Eden Prairie, Minnesota, United States