Deucravacitinib Pregnancy Study: A Retrospective Observational Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 833
- 试验地点
- 1
- 主要终点
- Number of infants born with Major Congenital Malformations (MCMs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
研究组 & 干预措施
Cohort 1
Participants exposed to deucravacitinib for the full pregnancy duration
干预措施: Deucravacitinib (Drug)
Cohort 2
Participants exposed to deucravacitinib for the first trimester
干预措施: Deucravacitinib (Drug)
Cohort 3
Participants exposed to deucravacitinib for the first 20 weeks of gestation
干预措施: Deucravacitinib (Drug)
Cohort 4
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
干预措施: Systemic psoriasis medications (Drug)
Cohort 5
Participants exposed to other systemic psoriasis medications for the first trimester
干预措施: Systemic psoriasis medications (Drug)
Cohort 6
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
干预措施: Systemic psoriasis medications (Drug)
Cohort 7
Participants not exposed to any systemic medications for the full pregnancy duration
干预措施: No systemic medications (Other)
Cohort 8
Participants not exposed to any systemic medications during the first trimester
干预措施: No systemic medications (Other)
Cohort 9
Participants not exposed to any systemic medications during the first 20 weeks of gestation
干预措施: No systemic medications (Other)
结局指标
主要结局
Number of infants born with Major Congenital Malformations (MCMs)
时间窗: Up to 12 months after birth or date of health plan disenrollment
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)
次要结局
- Pregnancy outcomes(Up to 9 months or date of health plan disenrollment)
- Infant outcomes(Up to 12 months after birth or date of health plan disenrollment)