NCT00443950

Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Etanercept

Timeline

• Start date: 2006-06-01
• Completion: 2007-07-01
• First posted: 2007-03-07
• Last updated: 2007-12-13

Locations

6 sites across 1 country: China