A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

February 26, 2024 updated by: Bristol-Myers Squibb

ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Germany
      • Herne, Germany, 44625
        • Not yet recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Evidera
        • Contact:
          • Kristin Veley, Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study population will include pregnant women of any age who reside in the United States

Description

Inclusion Criteria:

  • Diagnosis of Multiple sclerosis (MS)
  • Currently or recently pregnant
  • Reside in a country where ozanimod is prescribed for treatment of MS

Exclusion Criteria:

  • Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC)
  • Exposure to known teratogens and/or investigational medications during pregnancy

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ozanimod-exposed
Pregnant women with a diagnosis of Multiple sclerosis (MS) who are exposed to ozanimod at any time during pregnancy
Unexposed comparator cohort with MS
Pregnant women with a diagnosis of MS who are not exposed to ozanimod at any time during pregnancy
Unexposed comparator cohort without MS
Pregnant women without a diagnosis of MS who are not exposed to ozanimod at any time during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major congenital malformations
Time Frame: Up to first year of life
Up to first year of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Minor congenital malformations
Time Frame: Up to first year of life
Up to first year of life
Pre-eclampsia
Time Frame: Through pregnancy
Through pregnancy
Eclampsia
Time Frame: Through pregnancy
Through pregnancy
Spontaneous abortion
Time Frame: Through pregnancy
Through pregnancy
Stillbirth
Time Frame: Through pregnancy
Through pregnancy
Elective termination
Time Frame: Through pregnancy
Through pregnancy
Preterm birth
Time Frame: Through pregnancy
Through pregnancy
Small for gestational age
Time Frame: Up to first year of life
Up to first year of life
Postnatal growth deficiency
Time Frame: Up to first year of life
Up to first year of life
Infant developmental deficiency
Time Frame: Up to first year of life
Up to first year of life
Perinatal death
Time Frame: Up to first year of life
Up to first year of life
Neonatal death
Time Frame: Up to first year of life
Up to first year of life
Infant death
Time Frame: Up to first year of life
Up to first year of life
Serious or opportunistic infant infection (SOI)
Time Frame: Up to first year of life
Up to first year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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