Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major structural defects in children
研究概览
简要总结
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.
The 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 information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.
These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.
The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
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
- 否
入选标准
- •Cohort 1: Tildrakizumab-Exposed Cohort
- •Pregnant women
- •Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy
- •Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
- •Cohort 2: Disease-Matched Comparison Cohort
- •Pregnant women
- •Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
- •No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
- •Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
排除标准
- •Cohort 1: Tildrakizumab-Exposed Cohort:
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect
- •Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- •Women who have used tildrakizumab for an indication other than a currently approved indication
- •Retrospective enrollment after the outcome of pregnancy is known
- •Cohort 2: Disease-Matched Comparison Cohort
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect
- •Exposure to tildrakizumab anytime during the current pregnancy
- •Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- •Retrospective enrollment after the outcome of pregnancy is known
研究组 & 干预措施
Tildrakizumab-Exposed Cohort
Exposure to tildrakizumab for the treatment of an approved indication
干预措施: Pregnant women exposed to tildrakizumab (Drug)
Disease-Matched Comparison Cohort
No exposure to tildrakizumab at any time in the current pregnancy
干预措施: Pregnant women not exposed to tildrakizumab (Drug)
结局指标
主要结局
Major structural defects in children
时间窗: Up to 1 year of age
defined and classified using the US 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
- Spontaneous abortion/miscarriage(20 weeks post-last menstrual period)
- Stillbirth(from 20 weeks post-last menstrual period to end of pregnancy)
- Elective termination/abortion(At the end of pregnancy or through 9 month pregnancy period)
- neonatal/infant death(6 months of age)
- Small for gestational age(at birth)
- Postnatal growth deficiency(Up to 1 year of age)
- Malignancies in live born children(Up to 1 year of age)
- Hospitalization in live born children(Up to 1 year of age)
- Postnatal serious or opportunistic infection in live born children(Up to 1 year)