ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Female
View:
• Diagnosis of Multiple sclerosis (MS)
• Currently or recently pregnant
• Reside in the United States, Canada or Germany.
Locations
United States
North Carolina
ZEPOSIA MS Pregnancy Registry
RECRUITING
Wilmington
ZEPOSIA MS Pregnancy Registry
RECRUITING
Wilmington
Other Locations
Germany
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
RECRUITING
Herne
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2032-06-30
Participants
Target number of participants: 1182
Treatments
Ozanimod-exposed participants
Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window.
Comparator-exposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other sphingosine 1-phosphate (S1P) therapies during the exposure window but who are exposed to other products approved to treat MS during the exposure window.
Unexposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window.
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb