A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Recruiting
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT05170126
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1182
Inclusion Criteria
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
Exclusion Criteria
• Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major congenital malformations Up to first year of life
- Secondary Outcome Measures
Name Time Method Minor congenital malformations Up to first year of life Postnatal growth deficiency Up to first year of life Neonatal death Up to first year of life Serious or opportunistic infant infection (SOI) Up to first year of life Spontaneous abortion Through pregnancy Stillbirth Through pregnancy Preterm birth Through pregnancy Perinatal death Up to first year of life Pre-eclampsia Through pregnancy Eclampsia Through pregnancy Elective termination Through pregnancy Small for gestational age Up to first year of life Infant developmental deficiency Up to first year of life Infant death Up to first year of life
Trial Locations
- Locations (2)
ZEPOSIA MS Pregnancy Registry
🇺🇸Wilmington, North Carolina, United States
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
🇩🇪Herne, Germany