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

a study on Psoriasis Pregnancy Arthritis Crohn's Disease Inflammatory Bowel Disease

Summary

for females (full criteria)
at La Jolla, California
study started
estimated completion
Christina Chambers, PhD, MPH

Description

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.

Official Title

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

Details

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.

Keywords

Psoriasis Pregnancy Psoriatic Arthritis Crohn Disease autoimmune disease Stelara ustekinumab birth outcome malformation birth defect Crohn's Disease Tremfya guselkumab Arthritis Arthritis, Psoriatic Autoimmune Diseases Antibodies, Monoclonal Stelara (ustekinumab) exposed Tremfya (guselkumab) exposed

Eligibility

You can join if…

Open to females

  • 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 CAN'T join 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.

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist

  • Christina Chambers, PhD, MPH
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Director of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital. She is a perinatal epidemiologist, whose research is focused on environmental exposures and pregnancy and child health outcomes, including birth defects.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
Links
Official research website of the Organization of Teratology Information Specialists, Studies coordinated at the University of California, San Diego
ID
NCT02103361
Study Type
Observational [Patient Registry]
Last Updated