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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is ACR20 response at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician global assessments | ||
| Morning stiffness in minutes | ||
| Pain visual analog scale(VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100029 | China | ||||
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 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 |
| Beijing |
| 100044 |
| China |
| Beijing | 100853 | China |
| Guangzhou | 510275 | China |
| Shanghai | 200001 | China |
| Xi'an | 710032 | China |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |