Stelara & Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The purpose of the Stelara and Tremfya 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 or Tremfya 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02103361
Study type	Observational [Patient Registry]
Source	University of California, San Diego
Contact	Diana Johnson, MS
Phone	877-311-8972
Email	d4johnson@ucsd.edu
Status	Recruiting
Phase
Start date	November 2013
Completion date	December 2025

View Details

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