Arthritis, Rheumatoid
Conditions
Keywords
Arthritis, Chinese
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.
Interventions
DRUGEtanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is ACR20 response at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Morning stiffness in minutes | — |
| Pain visual analog scale(VAS) | — |
| Health assessment questionnaire(HAQ) | — |
| C-reactive protein (CRP) values, Subject global assessments | — |
| Physician global assessments | — |
| ACR20 (at visit other than week 12) | — |
| ACR50 | — |
| ACR70 responses | — |
| Number of tender and swollen joints | — |
Countries
China
Outcome results
None listed