CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 639 enrolled
Drug / intervention
Etanerceptbiological
Likely dose
Etanercept 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00357903
NCT00357903Phase 3Completed
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Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials

Amgen·interventional·Posted Jul 28, 2006·Updated Feb 9, 2017

In Brief

A Phase 3 clinical trial evaluating Etanercept for Rheumatoid Arthritis. Completed, enrolled 639 participants.

Detailed Summary

This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
CollaboratorsImmunex Corporation

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2006
Enrollment StartApr 1, 1997
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 19.9 years ago

Interventions

Etanerceptbiological

Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).