Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
Sponsor:
Brief Summary:
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.
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.
Locations
- Investigator, San Diego, California, United States, 92093
