Summary

for females (full criteria)
healthy people welcome
at La Jolla, California
study started
estimated completion:

Description

Summary

The purpose of the OTIS Autoimmune disease 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 that 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

Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

Keywords

Crohn's Disease Rheumatoid Arthritis Autoimmune diseases adalimumab pregnancy birth defects TNF Tumor necrosis factor Arthritis Arthritis, Rheumatoid Crohn Disease

Eligibility

For females

Inclusion Criteria:

  • Currently pregnant

Location

  • University of California, San Diego
    La Jolla, California, 92093-0828, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT01086059
Lead Scientist
Kenneth L Jones
Study Type
Observational
Last Updated
March 2017