The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Unnamed facility
Xi'an, China
The primary endpoint is ACR20 response at 12 weeks.
Physician global assessments
Morning stiffness in minutes
Pain visual analog scale(VAS)
Health assessment questionnaire(HAQ)
C-reactive protein (CRP) values, Subject global assessments
Number of tender and swollen joints
ACR20 (at visit other than week 12)
ACR50
ACR70 responses
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.