RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-14
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05170126

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Multiple sclerosis (MS)
  2. * Currently or recently pregnant
  3. * Reside in a country where ozanimod is prescribed for treatment of MS
  1. * Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC)
  2. * Exposure to known teratogens and/or investigational medications during pregnancy

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Evidera
Bethesda, Maryland, 20814
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2022-01-14
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2022-01-14
Study Completion Date2031-06-30

Terms related to this study

Keywords Provided by Researchers

  • Multiple Sclerosis
  • Ozanimod
  • Pregnancy
  • Outcomes
  • Obstetric
  • Infant

Additional Relevant MeSH Terms

  • Multiple Sclerosis