An Observational Study on Teriflunomide-exposed Pregnancies
Brief description of study
To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
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 of study
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.
Clinical Study Identifier: NCT03198351
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Sclerosis
Age: 16 Years
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).
- 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.
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