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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06126835

Collaborator

(none)

2,828

Enrollment

Location

Anticipated Duration (Months)

32.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Ozanimod Drug: Conventional therapy Drug: Advanced therapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

2828 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2024

Anticipated Primary Completion Date :

May 31, 2031

Anticipated Study Completion Date :

May 31, 2031

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OptumInsight Life Sciences Inc	Eden Prairie	Minnesota	United States	55344

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT06126835

Other Study ID Numbers:

IM047-025

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023