MedTrace Logo

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

NCT02103361 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-01-28

No results posted yet for this 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.

Conditions

Interventions

DRUG

Ustekinumab

DRUG

Guselkumab

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2030-05-31
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103361 on ClinicalTrials.gov