Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
Overview
- Phase
- Not Applicable
- Intervention
- Teriflunomide (HMR1726)
- Conditions
- Multiple Sclerosis
- Sponsor
- Sanofi
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Rate of major structural defects in live born infants
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort I
Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy
Intervention: Teriflunomide (HMR1726)
Outcomes
Primary Outcomes
Rate of major structural defects in live born infants
Time Frame: Up to the infant's first year birthday
Secondary Outcomes
- 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)