RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2013-11
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02103361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)
  1. * 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.

Contacts and Locations

Study Contact

Diana Johnson, MS
CONTACT
877-311-8972
d4johnson@ucsd.edu
Christina Chambers, PhD, MPH
CONTACT
877-311-8972
chchambers@ucsd.edu

Principal Investigator

Christina Chambers, PhD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Christina Chambers, PhD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-11
Study Completion Date2025-12

Study Record Updates

Study Start Date2013-11
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • autoimmune disease
  • pregnancy
  • psoriasis
  • Stelara
  • ustekinumab
  • birth outcome
  • malformation
  • birth defect
  • psoriatic arthritis
  • Crohn's Disease
  • Tremfya
  • guselkumab

Additional Relevant MeSH Terms

  • Psoriasis
  • Pregnancy
  • Psoriatic Arthritis
  • Crohn Disease