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The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozanimod exposed |
| ||
| Conventional therapy exposed |
| ||
| Advanced therapy exposed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Women with UC exposed to ozanimod during pregnancy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of major congenital malformations among infants | To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of spontaneous abortions | Up to 10 years | |
| Number of stillbirths | Up to 10 years | |
| Number of participants with pre-eclampsia |
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Inclusion Criteria:
Exclusion Criteria:
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Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OptumInsight Life Sciences Inc | Eden Prairie | Minnesota | 55344 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| Conventional therapy |
| Drug |
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy |
|
| Advanced therapy | Drug | Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy |
|
| Up to 10 years |
| Number of participants with eclampsia | Up to 10 years |
| Number of preterm births | Up to 10 years |
| Number of infants small for gestational age | Up to 10 years |
| Number of serious or opportunistic infections in liveborn infants up to 1 year of age | Up to 10 years |
| Number of infant postnatal growth deficiencies | Up to 10 years |
| Number of infant developmental deficiencies | Up to 10 years |
| Number of neonatal hospitalizations | Up to 10 years |
| Number of infant deaths | Up to 10 years |
| Number of neonatal deaths | Up to 10 years |
| Number of perinatal deaths | Up to 10 years |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |