Multiple Sclerosis
Conditions
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.
Interventions
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Pregnant women who have provided an oral and/or written consent to enroll no later than 20 completed weeks from last menstrual period (LMP). * Pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants (up to 1 year post birth). * Pregnant women with a diagnosis of MS and teriflunomide exposure during pregnancy (Cohort 1). * Pregnant women with MS but not exposed teriflunomide during pregnancy (Cohort 2). * Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen during pregnancy (Cohort 3).
Exclusion criteria
* Pregnant women who come in first contact with the project after prenatal diagnosis of a major structural defect (Cohort 1, 2, 3). This does not apply to the registry group. * Pregnant women who first come in contact with the project after 20 completed weeks' gestation (Cohort 1, 2, 3). This does not apply to the registry group. * Pregnant women who had previously enrolled in the study for a previous pregnancy (only 1 pregnancy, per woman, maybe registered) (Cohort 1, 2, 3). This does not apply to the registry group. * Retrospectively reported cases (Cohort 1, 2, 3). This does not apply to the registry group. * Pregnant women with exposures to teriflunomide commencing after the 12th week post-LMP (Cohort 1). This does not apply to the registry group. * Pregnant women who had previously been treated with teriflunomide if they had received any dose of the drug within 2 years prior to the index pregnancy and do not have documented blood levels below 0.02 mcg/mL prior to pregnancy (Cohort 2). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of major structural defects in live born infants | Up to the infant's first year birthday |
Secondary
| Measure | Time frame |
|---|---|
| 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 major structural defects in all pregnancies | up to 1 year of age in infant |
| 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 |
| 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 |
| Rate of preterm delivery | live birth prior to 37 weeks gestation |
Countries
Canada, United States
Outcome results
None listed