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Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
NCT02103361 · University of California, San Diego
In plain English
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Official title
Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
About this study
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.
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.
Study design
Enrollment target: 200 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2013-11
Estimated completion: 2031-02
Last updated: 2025-01-28
Interventions
Drug: UstekinumabDrug: Guselkumab
Primary outcomes
- • Major structural malformations (From 3 months prior to the first day of the last menstrual period and up to one year of age)
Sponsor
University of California, San Diego · other
With: The Organization of Teratology Information Specialists, Janssen Biotech, Inc.
Contacts & investigators
ContactDiana Johnson, MS · contact · d4johnson@ucsd.edu · 877-311-8972
ContactChristina Chambers, PhD, MPH · contact · chchambers@ucsd.edu · 877-311-8972
InvestigatorChristina Chambers, PhD, MPH · principal_investigator, University of California, San Diego
All locations (1)
University of California, San DiegoRecruiting
La Jolla, California, United States