Summary

for females (full criteria)
healthy people welcome
at San Diego, California
study started
estimated completion:
Christina Chambers

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 five years 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

Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project

Details

The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Keywords

Crohn's Disease Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Autoimmune disease certolizumab pegol Cimzia pregnancy birth defect birth outcome TNF Tumor necrosis factor Arthritis Arthritis, Rheumatoid Crohn Disease Spondylitis Spondylitis, Ankylosing Arthritis, Psoriatic Autoimmune Diseases

Eligibility

For females

Inclusion Criteria:

  • Currently pregnant

Location

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

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 Coordinated at the University of California, San Diego
ID
NCT01797224
Lead Scientist
Christina Chambers
Study Type
Observational
Last Updated
March 2017