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Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Recruitingn/aAges any - anyFemaleUniversity of California, San Diego
NCT02103361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ustekinumab
  • Guselkumab
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Where

1 site
University of California, San Diego
La Jolla, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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