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The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were exposed to deucravacitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib Cohort | Pregnant participants with psoriasis exposed to deucravacitinib treatment |
| |
| Other Systemic Treatment Cohort | Pregnant participants with psoriasis exposed to other systemic treatments for PsO |
| |
| Unexposed Cohort | Pregnant participants without psoriasis or any other autoimmune diseases |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | According to product label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of major congenital malformations among infants | 1-year post pregnancy outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Number of other pregnancy and infant outcomes | Other pregnancy and infant outcomes include:
|
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Inclusion Criteria:
Cohort 1: Deucravacitinib-exposed cohort
Cohort 2: PsO Disease-matched unexposed comparator cohort
Cohort 3: Non-disease unexposed comparator cohort
Exclusion Criteria
Cohort 1: Deucravacitinib-exposed cohort
Cohort 2: Disease-matched unexposed comparator cohort
Cohort 3: Non-disease unexposed comparator cohort
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The study population will include pregnant women participating in the The Organization of Teratology Information Specialists (OTIS) pregnancy registry in the US or Canada
| 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 NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92037 | 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 |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Other systemic treatments for PsO |
| Drug |
According to product label |
|
| 1-year post pregnancy outcome |