A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

N/AActive Not RecruitingNCT06710470

Bristol-Myers Squibb833 enrolled

Overview

This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.

Study Type

OBSERVATIONAL

Enrollment

833

Conditions

Psoriasis

Interventions

DeucravacitinibDRUG

As per product label

Systemic psoriasis medicationsDRUG

As per product label

No systemic medicationsOTHER

Participants not exposed to any systemic medications

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Maternal age 15 through 50 years at date of conception * 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: • Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window

Locations (1)

Bristol-Meyers Squibb

Lawrenceville, New Jersey, United States

Outcomes

Primary Outcomes

Number of infants born with Major Congenital Malformations (MCMs)

MCMs defined as a structural abnormality with surgical, medical, or cosmetic importance (excluding chromosomal abnormalities or physiological features due to complications of prematurity, such as cryptorchidism, inguinal hernia, or isolated patent ductus arteriosus in infants born less than 37 weeks of gestation)

Time frame: Up to 12 months after birth or date of health plan disenrollment

Secondary Outcomes

Pregnancy outcomes

Incidence of the following pregnancy outcomes: spontaneous abortion, induced abortion, ectopic pregnancy, stillbirth, pre-eclampsia, eclampsia and gestational diabetes

Time frame: Up to 9 months or date of health plan disenrollment

Infant outcomes

Incidence of the following infant outcomes: small for gestational age, large for gestational age, low birthweight, preterm birth, serious or opportunistic infections, postnatal growth deficiency, infant developmental deficiency, neonatal hospitalization, and infant/neonatal/perinatal death

Time frame: Up to 12 months after birth or date of health plan disenrollment

Data from ClinicalTrials.gov

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