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Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Who can join
All ages · Women
Full eligibility criteria
Inclusion Criteria: * Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) 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) or Tremfya (guselkumab) Exclusion Criteria: * Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.
About the 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.
What is being tested
- Ustekinumab (drug)
- Guselkumab (drug)
Sponsor: University of California, San Diego · Participants: 200 · Started: 2013-11
Contact the study team
- Diana Johnson, MS · Phone: 877-311-8972
- Christina Chambers, PhD, MPH · Phone: 877-311-8972
Official record on ClinicalTrials.gov — NCT02103361
Locations in the U.S.
| California | University of California, San Diego, La Jolla |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.