Last updated on February 2018

Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project


Brief description of study

The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Detailed Study Description

The purpose of the Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

Clinical Study Identifier: NCT02103361

Contact Investigators or Research Sites near you

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Christina Chambers, PhD, MPH

University of California, San Diego
La Jolla, CA United States
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