Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00443950
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Must be of Chinese ancestry and living in China.
- Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
- Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.
Exclusion Criteria
- Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint is ACR20 response at 12 weeks.
- Secondary Outcome Measures
Name Time Method 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 Physician global assessments Morning stiffness in minutes