Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Ozanimod, Pregnancy, Outcomes, Obstetric, Infant
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major congenital malformations | Up to first year of life |
Secondary
| Measure | Time frame |
|---|---|
| Perinatal death | Up to first year of life |
| Neonatal death | Up to first year of life |
| Infant death | Up to first year of life |
| Serious or opportunistic infant infection (SOI) | Up to first year of life |
| Preterm birth | Through pregnancy |
| Small for gestational age | Up to first year of life |
| Infant developmental deficiency | Up to first year of life |
| Minor congenital malformations | Up to first year of life |
| Pre-eclampsia | Through pregnancy |
| Eclampsia | Through pregnancy |
| Spontaneous abortion | Through pregnancy |
| Stillbirth | Through pregnancy |
| Elective termination | Through pregnancy |
| Postnatal growth deficiency | Up to first year of life |
Countries
Germany, United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed