The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
Bristol-Myers Squibb
Summary
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.
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: Cohort 1: Deucravacitinib-exposed cohort * Currently pregnant during the enrollment period * Diagnosed with psoriasis (PsO) validated by medical records when possible * Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy * Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants Cohort 2: PsO Disease-matched unexposed comparator cohort * Currently pregnant duri…
Interventions
- DrugDeucravacitinib
According to product label
- DrugOther systemic treatments for PsO
According to product label
Location
- University of California San DiegoLa Jolla, California