OTIS Autoimmune Diseases in Pregnancy Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 830
- 试验地点
- 1
- 主要终点
- Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
研究概览
简要总结
The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.
详细描述
This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout North America.
Participants in the first two cohorts are recruited concurrently from callers to OTIS centers, from health care providers and through direct to consumer marketing efforts. The source of historical controls is archived data on pregnancies that have been followed through the California Teratogen Information Service's Clinical Research Program located at the University of California San Diego.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects will be currently pregnant women residing in the US or Canada who have had any exposure to etanercept for treatment of Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) at any time during the first trimester of pregnancy which is defined as the period between first day of the last menstrual period (i.e., within two weeks of conception) up to and including the 12th week after the first day of the last menstrual period (LMP) - Eligible subjects must have documentation of an exposure to etanercept during the first trimester of pregnancy.
- •Cohort 2 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in the US or Canada who have not taken etanercept or any TNF antagonist for treatment of RA, JRA, AS, PsoA or PsO at any time in the current pregnancy or within two months prior to the first day of the last menstrual period (LMP).
- •Cohort 3 Inclusion Criteria: Eligible subjects will be pregnant women who were residing in the US or Canada who had not been diagnosed with RA, JRA, AS, PsoA or PsO and had not been exposed to a known human teratogen during the index pregnancy.
排除标准
- 未提供
研究组 & 干预措施
Etanercept-Exposed
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
干预措施: Etanercept (Drug)
结局指标
主要结局
Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
时间窗: From birth through 1 year of age
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Percentage of Infants With Major Birth Defects in All Pregnancies
时间窗: From birth through 1 year of age
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
次要结局
- Percentage of Infants With Any 3 or More Minor Birth Defects(From birth through 1 year of age)
- Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects(From birth through 1 year of age)
- Postnatal Length Percentile at One Year(1 year after birth)
- Percentage of Infants at One Year of Age With Small for Gestational Age Weight(1 year after birth)
- Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year(From birth to 1 year)
- Birth Length Among Full Term Infants(At birth)
- Percentage of Infants With Small for Gestational Age Birth Length(At birth)
- Percentage of Infants With Small for Gestational Age Birth Head Circumference(At birth)
- Percentage of Infants at One Year of Age With Small for Gestational Age Length(1 year after birth)
- Percentage of Pregnancies Ending in Spontaneous Abortion(9 months)
- Birth Head Circumference Among Full Term Infants(At birth)
- Postnatal Weight Percentile at One Year(1 year after birth)
- Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference(1 year after birth)
- Gestational Age at Delivery (GAD) of Live Births(At birth)
- Percentage of Participants With Pre-term Delivery(9 months)
- Birth Weight Among Full Term Infants(At birth)
- Percentage of Infants With Small for Gestational Age Birth Weight(At birth)
- Postnatal Head Circumference Percentile at One Year(1 year after birth)
- Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age(From birth to 1 year)
- Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)(1 year after birth)