International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 24
- 主要终点
- Spontaneous abortions (≤20 weeks gestation)
研究概览
简要总结
Primary Objective:
The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis.
Secondary Objective:
The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.
详细描述
From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with Multiple Sclerosis who were or became pregnant within the period of time between the first infusion of a course of treatment with LEMTRADA to 4 months after their last infusion for that course.
- •Women able and willing to provide informed consent for study participation and the requirement of the study. Informed consent will be obtained at the time of enrollment in accordance with local regulatory requirements.
排除标准
- •- Previous enrollment in this study for a previous pregnancy.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Lemtrada
Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course
干预措施: Alemtuzumab (GZ402673) (Drug)
结局指标
主要结局
Spontaneous abortions (≤20 weeks gestation)
时间窗: 32 weeks gestation
Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
次要结局
- Elective terminations i.e. any induced or voluntary fetal loss(16-20 weeks' gestation)
- Major congenital malformations(From birth to 1 year after delivery)
- Minor congenital malformations(From birth to 1 year after delivery)
- Any other adverse pregnancy outcomes(Baseline to week 40)
- Stillbirth (any non-deliberate foetal death at >20 weeks gestation)(26-32 weeks' gestation to within 6 weeks after the end of the pregnancy)
- Full-term live birth i.e. infants born maturely (≥37 gestation weeks)(Within 6 weeks after the end of the pregnancy)
- Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)(26-32 weeks' gestation to within 6 weeks after the end of the pregnancy)
- Infant postnatal growth (up to the first year of life)(1 year after delivery)
- Infant development impairment (up to the first year of life)(1 year after delivery)
- Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age(Within 6 weeks after the end of the pregnancy)