Summary

Eligibility
for females (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Christina Chambers, PhD
Headshot of Christina Chambers
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, Psoriasis, Autoimmune disease, certolizumab pegol, Cimzia, pregnancy, birth defect, birth outcome, TNF, Tumor necrosis factor, Spondylitis, Arthritis, Crohn Disease, Autoimmune Diseases

Eligibility

For females

Inclusion Criteria:

  • Currently pregnant

Location

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

Lead Scientist at UCSD

  • Christina Chambers, PhD
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Vice Chair 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 MotherToBaby/OTIS Studies Coordinated at the University of California, San Diego
ID
NCT01797224
Study Type
Observational
Participants
Expecting 925 study participants
Last Updated