Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Biogen
- 入组人数
- 908
- 试验地点
- 15
- 主要终点
- Number of Major Congenital Malformations (MCMs)
研究概览
简要总结
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).
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
- •Participant must have a diagnosis of MS
- •Documentation that the participant was one of the following:
- •exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
- •unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
- •Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)
排除标准
- •NOTE: Other protocol defined Inclusion criteria may apply
研究组 & 干预措施
Dimethyl Fumarate
Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
干预措施: Dimethyl Fumarate (Drug)
Disease Modifying Therapy (DMTs) Exposed
Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
干预措施: Avonex (Drug)
Disease Modifying Therapy (DMTs) Exposed
Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
干预措施: Tysabri (Biological)
DMTs Unexposed
Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP or discontinued a non-Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP.
Women Without MS
Pregnant women with external, general population comparators.
Diroximel Fumarate
Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
干预措施: Diroximel Fumarate (Drug)
结局指标
主要结局
Number of Major Congenital Malformations (MCMs)
时间窗: Up to 52 weeks postdelivery
MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.
次要结局
- Number of Live Births(Up to delivery (approximately 10 months))
- Number of Maternal Deaths(Up to 12 weeks postdelivery)
- Number of Neonatal Deaths(Prior to 28 days postdelivery)
- Number of Elective or Therapeutic Terminations(Up to 9 months of pregnancy)
- Number of Spontaneous Abortions(Before 22 weeks of gestation)
- Number of Fetal Deaths Including Still Birth(At or after 22 weeks of gestation)
- Number of Ectopic Pregnancies(Up to 9 months of pregnancy)
- Number of Serious or Opportunistic Infections in Liveborn Children(Up to 52 weeks postdelivery)
- Number of Perinatal Deaths(At or after 28 days to 12 weeks postdelivery)
- Number of Infants with Abnormal Postnatal Growth and Development(Up to 52 weeks postdelivery)
- Number of Molar Pregnancies(Up to 9 months of pregnancy)
- Number of Infant Deaths(Between 12 to 52 weeks postdelivery)
- Number of Participants with Pregnancy Complications(Up to 9 months of pregnancy)