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Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project

NCT00116272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 830

Last updated 2023-10-06

Study results available
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Summary

The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.

Conditions

  • Pregnancy

Interventions

DRUG

Etanercept

Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00116272 on ClinicalTrials.gov