An Observational Study on Teriflunomide-exposed Pregnancies

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Multiple Sclerosis

Clinical Trial Details

NCT number	NCT03198351
Study type	Observational [Patient Registry]
Source	Sanofi
Contact
Status	Completed
Phase
Start date	April 25, 2013
Completion date	June 13, 2023

View Details

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