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Clinical Trial Summary

Primary Objective: To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies. Secondary Objective: To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.


Clinical Trial Description

Pregnant women enrolled in the study will participate for the duration of that pregnancy. Those who deliver at least one live born infant and the infants will participate for 1 year after delivery of that infant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03378219
Study type Observational
Source Sanofi
Contact
Status Active, not recruiting
Phase
Start date May 18, 2018
Completion date October 18, 2024