A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
NCT ID: NCT06710470
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
833 participants
OBSERVATIONAL
2024-08-02
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
Participants exposed to deucravacitinib for the full pregnancy duration
Deucravacitinib
As per product label
Cohort 2
Participants exposed to deucravacitinib for the first trimester
Deucravacitinib
As per product label
Cohort 3
Participants exposed to deucravacitinib for the first 20 weeks of gestation
Deucravacitinib
As per product label
Cohort 4
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Systemic psoriasis medications
As per product label
Cohort 5
Participants exposed to other systemic psoriasis medications for the first trimester
Systemic psoriasis medications
As per product label
Cohort 6
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Systemic psoriasis medications
As per product label
Cohort 7
Participants not exposed to any systemic medications for the full pregnancy duration
No systemic medications
Participants not exposed to any systemic medications
Cohort 8
Participants not exposed to any systemic medications during the first trimester
No systemic medications
Participants not exposed to any systemic medications
Cohort 9
Participants not exposed to any systemic medications during the first 20 weeks of gestation
No systemic medications
Participants not exposed to any systemic medications
Interventions
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Deucravacitinib
As per product label
Systemic psoriasis medications
As per product label
No systemic medications
Participants not exposed to any systemic medications
Eligibility Criteria
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Inclusion Criteria
* Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
* Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
* Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy
Exclusion Criteria
15 Years
50 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Bristol-Meyers Squibb
Lawrenceville, New Jersey, United States
Countries
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Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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IM011-201
Identifier Type: -
Identifier Source: org_study_id