An Observational Study on Teriflunomide-exposed Pregnancies
- Registration Number
- NCT03198351
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort I Teriflunomide (HMR1726) Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy
- Primary Outcome Measures
Name Time Method Rate of major structural defects in live born infants Up to the infant's first year birthday
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
University of California at San Diego-Site Number:001
🇺🇸San Diego, California, United States
Investigational Site Number :002
🇨🇦Canada, Canada