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

NCT06126835 | Active Not Recruiting FDA Drug

• 1 other identifier: IM047-025
• Study Type: observational
• Target: 2,828
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (3)

Ozanimod exposed

Drug: Ozanimod

Conventional therapy exposed

Drug: Conventional therapy

Advanced therapy exposed

Drug: Advanced therapy

Interventions

Ozanimod DRUG

Women with UC exposed to ozanimod during pregnancy

Ozanimod exposed

Conventional therapy DRUG

Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy

Conventional therapy exposed

Advanced therapy DRUG

Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

Advanced therapy exposed

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

OptumInsight Life Sciences Inc

Eden Prairie, Minnesota, 55344, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: November 13, 2023
• Study Start: August 26, 2024
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)