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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT02103361
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Nov 30, 2013
Status verified
Jan 2025
Primary completion
May 31, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Stelara (ustekinumab) exposed
    Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)
  • Arm: Tremfya (guselkumab) exposed
    Tremfya (guselkumab-exposed pregnant women

Primary Outcome Measure

Major structural malformations [ Time Frame: From 3 months prior to the first day of the last menstrual period and up to one year of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Johnson
Christina Chambers, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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