Overview

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

Status:
Completed

Trial end date:
2007-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Etanercept

Criteria

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).