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

Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Ozanimod; Drug: Conventional therapy; Drug: Advanced therapy

• Study Type: Observational
• Enrollment (Estimated): 2828

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • OptumInsight Life Sciences Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ozanimod exposed	Drug: Ozanimod; Women with UC exposed to ozanimod during pregnancy
Conventional therapy exposed	Drug: Conventional therapy; Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
Advanced therapy exposed	Drug: Advanced therapy; Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of major congenital malformations among infants	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.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of spontaneous abortions	Up to 10 years
Number of stillbirths	Up to 10 years
Number of participants with pre-eclampsia	Up to 10 years
Number of participants with 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 serious or opportunistic infections in liveborn infants up to 1 year of 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 infant deaths	Up to 10 years
Number of neonatal deaths	Up to 10 years
Number of perinatal deaths	Up to 10 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Ozanimod
• Other Study ID Numbers: IM047-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No