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

Last updated: January 26, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Arthritis And Arthritic Pain

Connective Tissue Diseases

Treatment

Guselkumab

Ustekinumab

Clinical Study ID

NCT02103361
CNTO1275PSO4037
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) duringpregnancy 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 untilcompletion of pregnancy.

  • Documentation of gestational timing of the exposure to Stelara (ustekinumab) orTremfya (guselkumab)

Exclusion

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

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase:
Study Start date:
November 01, 2013
Estimated Completion Date:
February 28, 2031

Study Description

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.

Connect with a study center

  • University of California, San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

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