At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 151 enrolled
Drug / intervention
ETN Alone +1 moredrug
Likely dose
ETN Alone 25 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.
Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan
Japan Biological Agent Study Integrated Consortium·interventional·Posted Jun 2, 2008·Updated Oct 1, 2015
In Brief
A Phase 4 clinical trial evaluating ETN Alone and ETN+MTX for Rheumatoid Arthritis. Completed, enrolled 151 participants across 1 site.
Detailed Summary
Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups. 1. Etanercept alone treatment group (25mg, twice/week, s.c.) 2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedJun 2008
Primary CompletionOct 2008
Study CompletionOct 2010
TodayJul 2026
First PostedJun 2, 2008
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2008
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.1 years ago
Interventions
ETN Alonedrug
etanercept (25 mg, twice/week, s.c.)
ETN+MTXdrug
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)