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

Recruiting now

Conditions studied: Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease

In brief

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.

Key facts

Study ID

NCT02103361

Run by

University of California, San Diego

People needed

200

Starts

2013-11-01

Expected to finish

2031-02-01

Last updated by the study team

2025-01-28

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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