Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Rate of major structural defects in live born infants
研究概览
简要总结
Primary Objective:
To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
Secondary Objective:
To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.
详细描述
The total study duration per participant is approximately up to 2 years.
- This is a prospective, observational study (no intervention), ie, patient registry.
- The statistical analysis for the cohort study describe baseline characteristics in all three cohorts, and then will compare pregnancy outcomes in cohort 1 to cohort 2 and secondarily to cohort 3.
- For the "registry" group, without comparisons, only descriptive statistics of pregnancy outcomes will be summarized.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort I
Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy
干预措施: Teriflunomide (HMR1726) (Drug)
结局指标
主要结局
Rate of major structural defects in live born infants
时间窗: Up to the infant's first year birthday
次要结局
- Proportion of major structural defects in all pregnancies(up to 1 year of age in infant)
- Rate of preterm delivery(live birth prior to 37 weeks gestation)
- Proportion of infants who are small for gestational age (less than or equal to the 10th percentile for gestational age and sex) on weight, length, or head circumference(at birth)
- Specific pattern of 3 or more minor structural defects in live born infants receiving the exam(up to one year after birth)
- Rate of spontaneous abortion(date of conception to 20 weeks gestation)
- Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation(1 year)