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NCT05170126 Clinical Trial

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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05170126
Other study ID # IM047-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date June 30, 2031

Study information
Verified date February 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1182
Est. completion date June 30, 2031
Est. primary completion date June 30, 2031
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Local Institution - 0002 Herne
United States Evidera Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Germany, 

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