Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Rate of major structural birth defect
研究概览
简要总结
Primary Objective:
To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.
Secondary Objective:
To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.
详细描述
Pregnant women enrolled in the study will participate for the duration of that pregnancy. Those who deliver at least one live born infant and the infants will participate for 1 year after delivery of that infant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Sarilumab-Exposed Cohort: Pregnant women exposed to Kevzara (sarilumab) for the treatment of an approved Kevzara (sarilumab) indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
干预措施: Sarilumab SAR153191 (REGN88) (Drug)
结局指标
主要结局
Rate of major structural birth defect
时间窗: Up to 1 year of age of the infant
A major structural birth defect is a defect that has either cosmetic or functional significance to the child (eg, a cleft lip) and is identified up to one year of age by the mother, the health care provider/medical record, or identified in the dysmorphological examination.
次要结局
- Pregnancy Outcomes: Spontaneous abortion(Date of conception to 20 weeks gestation)
- Pregnancy Outcomes: Stillbirth(After 20 weeks of gestation but prior to delivery)
- Pregnancy Outcomes: Premature delivery(Live birth prior to 37 weeks gestation)
- Infant Outcomes: pattern of minor structural birth defects(Up to 1 year of age of the infant)
- Infant Outcomes: Postnatal growth deficiency(Up to 1 year of age of the infant)
- Infant Outcomes: Malignancies(Up to 1 year of age of the infant -)
- Infant Outcomes: Small for gestational age(At birth)
- Infant Outcomes: Serious or opportunistic infections(Up to 1 year of age of the infant)
- Infant Outcomes: Hospitalizations(Up to 1 year of age of the infant)