Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- The number of major structural malformations identified in the children of study participants
研究概览
简要总结
The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.
详细描述
The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada.
The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age.
The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and the effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.
The Pregnancy Exposure Registry is sponsored by Celgene Corporation and is conducted by the Organization of Teratology Information Specialists (OTIS) Research Group and is administered by investigators at the coordinating site located at the University of California, San Diego. The study is planned for seven years.
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
Apremilast-Exposed Cohort
Women who have been exposed to apremilast in pregnancy for an approved indication in the first trimester of pregnancy for any length of time from the date of conception.
干预措施: apremilast (Drug)
Apremilast-Exposed Registry Group
Women who have been exposed to apremilast in pregnancy, for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study.
干预措施: apremilast (Drug)
结局指标
主要结局
The number of major structural malformations identified in the children of study participants
时间窗: Throughout pregnancy through 1 year of life
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects in children of study participants. The study is analyzing the difference in the number of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
A pattern of major malformations identified in the children of study participants
时间窗: Throughout pregnancy through 1 year of life
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to a pattern of major malformations in children of study participants. The study is analyzing the difference in the pattern of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records.
次要结局
- Pattern of minor structural malformations identified by study physical exam in the children of study participants(Assessed when the dysmorphology exam is conducted, which will occur between birth of the child and through study completion, an average of 1 year of age)
- Gestational age at delivery among infants in the cohort groups(At the end of pregnancy)
- Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study(Up to one year of age of the child)
- Pregnancy Complication rates between cohort groups(From the first day of the last menstrual period (LMP) through delivery)
- Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups(At the end of pregnancy)
- Neonatal Complication rates between cohort groups(Birth of the child to 1 month of age.)
- Pre- and post-natal fetal and infant growth percentiles(From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child)
- Any malignancies diagnosed in infants of mothers enrolled in the study(Up to one year of age of the child)
研究者
Christina Chambers
Professor, Co-Director Center for Promotion of Maternal Health and Infant Development
University of California, San Diego