An Observational Study on Teriflunomide-exposed Pregnancies

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03198351

Run by

Sanofi

People needed

220

Starts

2013-04-25

Expected to finish

2023-06-13

Last updated by the study team

2023-08-28

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California at San Diego-Site Number:001 — San Diego, California, United States
• Investigational Site Number :002 — Canada, Canada

Full record on ClinicalTrials.gov

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