Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Number of major congenital malformations (MCM) among live births
研究概览
简要总结
The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.
详细描述
Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The following overall criteria for study inclusion are applied:
- •Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period
- •Age 18-49 years at index date
- •A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources
- •Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date
- •In addition, the following outcome and objective specific inclusion criteria are applied:
- •For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth
- •For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth, preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy
- •For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at least one live birth
- •For analyses of MCMs among live births, spontaneous abortions, stillbirths, and elective terminations (exploratory objective): pregnancy ending in at least one live birth, spontaneous abortion, still birth, or elective termination
- •For analyses of neonatal infection: live newborn
- •For analyses of SII: newborn alive at 29 days after birth
排除标准
- •The following overall criteria for exclusion are applied:
- •Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- •Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- •The following outcome specific exclusion criteria are applied:
- •For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
- •For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples
- •For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period
结局指标
主要结局
Number of major congenital malformations (MCM) among live births
时间窗: First year of life, up to 12 months
The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth. MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip)
次要结局
- Number of participants with spontaneous abortions(Up to 9 months)
- Number of participants with elective termination of pregnancy(Up to 9 months)
- Number of participants with preeclampsia(Up to 9 months)
- Number of participants with stillbirths(Up to 9 months)
- Number of participants with preterm births(Up to 9 months)
- Number of participants with eclampsia(Up to 9 months)
- Number of participants small for gestational age (SGA)(Up to 9 months)