CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 830 enrolled
Drug / intervention
Etanerceptdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Currently pregnant women residing in the US or Canada
  • ✓Cohort 1: Any etanercept exposure during first trimester (from LMP through week 12) for RA, JRA, AS, PsoA, or PsO
  • ✓Cohort 1: Documented proof of etanercept exposure during first trimester
  • ✓Cohort 2: No etanercept or TNF antagonist use in current pregnancy or within 2 months prior to LMP, but may have diagnosed inflammatory disease
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116272
NCT00116272N/ACompleted
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OTIS Autoimmune Diseases in Pregnancy Project

Amgen·observational·Posted Jun 29, 2005·Updated Oct 6, 2023

In Brief

An observational study evaluating Etanercept for Pregnancy. Completed, enrolled 830 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2005
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 21.0 years ago

Interventions

Etanerceptdrug

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