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The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozanimod-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy | ||
| Conventional therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy | ||
| Advanced therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy |
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| Measure | Description | Time Frame |
|---|---|---|
| Event rate of Major Congenital Malformations (MCM) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event rate of minor congenital malformations | Up to 12 months | |
| Event rate of pre-eclampsia | Up to 9 months | |
| Event rate of eclampsia |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined eligibility criteria apply.
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The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
| 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 |
|---|---|---|---|---|---|---|
| PPD Virtual - PPD - US | Recruiting | Wilmington | North Carolina | 28401-3331 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Up to 9 months |
| Event rate of Spontaneous Abortion (SAB) | Up to 9 months |
| Event rate of stillbirth | Up to 9 months |
| Event rate of elective termination | Up to 9 months |
| Event rate of preterm birth | Up to 9 months |
| Event rate of Small for Gestational Age (SGA) | Up to 12 months |
| Event rate of postnatal growth deficiency | Up to 12 months |
| Event rate of infant developmental deficiency | Up to 12 months |
| Event rate of perinatal death | Up to 10 months |
| Event rate of neonatal death | Up to 1 month |
| Event rate of infant death | Up to 12 months |
| Event rate of serious or opportunistic infant infections | Up to 12 months |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |