At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 enrolled
Drug / intervention
etanerceptdrug
Likely dose
etanercept 25mgfrom 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.
An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Jan 5, 2007·Updated Mar 2, 2012
In Brief
A Phase 3 clinical trial evaluating etanercept for Arthritis, Rheumatoid. Completed, enrolled 42 participants across 12 sites.
Detailed Summary
The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartFeb 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedJan 5, 2007
Enrollment StartFeb 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.5 years ago
Interventions
etanerceptdrug
Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)