Last updated on July 2018

An Observational Study on Teriflunomide-exposed Pregnancies


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03198351

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Investigator

San Diego, CA United States
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