Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 1
- 主要终点
- Rate of major structural defects
研究概览
简要总结
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.
The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Dupilumab-Exposed Cohort
- •Pregnant women
- •Exposure to dupilumab for the treatment of the approved indications of atopic dermatitis (AD) or asthma, for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.
- •Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- •Pregnant women
- •Diagnosed with a dupilumab-approved indications of moderate-to-severe AD without asthma or moderate-to-severe asthma; frequency matched to the exposed group by disease indication, with the indication and severity validated by medical records when possible.
- •No exposure to dupilumab any time in the current pregnancy or within 10 weeks of the first day of the LMP and may or may not have taken another medication for their disease in the current pregnancy.
- •Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
- •Pregnant women
排除标准
- •Cohort 1: Dupilumab-Exposed Cohort
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect
- •Women who have used dupilumab for an indication other than asthma or AD
- •Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect
- •Exposure to dupilumab within 10 weeks of LMP or anytime during the current pregnancy
- •Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2):
- •Exposure to dupilumab within 10 weeks prior to the first day of the LMP
- •Women who have a diagnosis of any dupilumab approved indication
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect
- •NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
Cohort 1: Dupilumab-Exposed Cohort
Pregnant women with approved indications exposed to dupilumab during pregnancy
干预措施: dupilumab (Drug)
Cohort 2: Disease-Matched Comparison Cohort
Pregnant women with approved indications not exposed to dupilumab during pregnancy
Cohort 3: Healthy Comparison Cohort
Pregnant women who are not diagnosed with any dupilumab-approved indications, and not exposed to dupilumab during pregnancy
结局指标
主要结局
Rate of major structural defects
时间窗: Up to 1 Year of Age
Defined and classified using the Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
次要结局
- Postnatal growth deficiency(Up to 1 Year of Age)
- Incidence of hospitalizations in live born children(Up to 1 Year of Age)
- Incidence of a pattern of 3 or more minor structural defects(Between Birth and Up to 1 Year of Age)
- Incidence of postnatal serious or opportunistic infections in live born children(Up to 1 Year of Age)
- Incidence of spontaneous abortion or miscarriage(Up to 20 weeks post-LMP (Last Menstrual period))
- Incidence of premature delivery(Prior to 37 weeks of gestation)
- Incidence of small for gestational age(At Birth)
- Incidence of stillbirth(At or after 20 weeks post-LMP)
- Incidence of elective termination/abortion(Up to 9 months)