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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major congenital malformations | Up to first year of life |
| Measure | Description | Time Frame |
|---|---|---|
| Minor congenital malformations | Up to first year of life | |
| Pre-eclampsia | Through pregnancy | |
| Eclampsia |
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Inclusion Criteria:
Exclusion Criteria:
• Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
Other protocol-defined inclusion/exclusion criteria apply
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Female
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The study population will include pregnant women of any age who reside in the United States, Canada or Germany.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera INC. | Recruiting | Bethesda | Maryland | 20814 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Through pregnancy |
| Spontaneous abortion | Through pregnancy |
| Stillbirth | Through pregnancy |
| Elective termination | Through pregnancy |
| Preterm birth | Through pregnancy |
| Small for gestational age | Up to first year of life |
| Postnatal growth deficiency | Up to first year of life |
| Infant developmental deficiency | Up to first year of life |
| 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 |
| Evidera | Recruiting | Bethesda | Maryland | 20814 | United States |
|
| Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum | Recruiting | Herne | 44625 | Germany |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |