Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Clinical Trial ID: NCT02103361

Description

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.

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.


Criteria

Inclusion Criteria: - Documentation of an exposure to Stelara (ustekinumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy. - Documentation of gestational timing of the exposure to Stelara (ustekinumab) Exclusion Criteria: - Women who have not have an exposure to Stelara (ustekinumab) during pregnancy.

  • Start Date

    2013-11-30

  • Last Updated

    2017-03-22

  • Sponsor

    Janssen Biotech, Inc.

  • Condition Name

    Crohn Disease

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