At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 468 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.
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
In Brief
A Phase 3 clinical trial evaluating Etanercept for Rheumatoid Arthritis. Completed, enrolled 468 participants.
Detailed Summary
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
CollaboratorsImmunex Corporation
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 1998
First PostedJul 2006
Primary CompletionDec 2008
Study CompletionApr 2009
TodayJul 2026
First PostedJul 26, 2006
Enrollment StartDec 1, 1998
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 19.9 years ago
Interventions
Etanerceptbiological
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.