Japanese 2006.

Trial name or title	A Randomised, Double‐Blind, Multi‐Centre, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects with Active Rheumatoid Arthritis
Methods	Multicentre, double‐blind (subjects, carers, investigators, outcome assessors), parallel group RCT
Participants	Inclusion: Japanese citizen living in Japan; 20 to 75 years; diagnosed ≤5 years from time of first visit Exclusion: Etanercept or TNF inhibitors such as infliximab, or adalimumab in the past; other rheumatic diseases or conditions that could predispose the person to infection, pregnant or lactating women
Interventions	Etanercept 10 or 25 mg SC twice weekly for 52 weeks vs. MTX (up to 8 mg/week) oral for 52 weeks
Outcomes	Primary: radiographic scores (change in modified TSS from baseline) at 52 weeks Secondary: adverse events incidence at 52 weeks
Starting date	June 2006
Contact information	clinicaltrialparticipation@wyeth.com
Notes	Estimated completion: October 2010. Funded by Wyeth