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The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| P1 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-582949 | Drug | Tablets, Oral, 300 mg, once daily, 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 | at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving an ACR 20 | at each scheduled visit | |
| Proportion of subjects schieving and ACR 50 | at each scheduled visit | |
| Proportion of subjects schieving and ACR 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Medical Advances | Palm Desert | California | 92260 | United States | ||
| Orrin M. Troum,M D |
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| Placebo | Drug | Tablets, Oral, placebo, once daily, 12 weeks |
|
| at each scheduled visit |
| Percent change from baseline to each scheduled visit in DAS28 score | at each scheduled visit |
| Percent change from baseline to each scheduled visit in ACR scores | at each scheduled visit |
| Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue | at each scheduled visit |
| Percent change from baseline to each scheduled visit in HAQ score | at each scheduled visit |
| Santa Monica |
| California |
| 90404 |
| United States |
| G. Timothy Kelly, Md | Las Vegas | Nevada | 81928 | United States |
| Health Research Of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Arthritis Clinic | Jackson | Tennessee | 38305 | United States |
| Walter F Chase Md | Austin | Texas | 78705 | United States |
| Tacoma Center For Arthritis Research Ps | Tacoma | Washington | 98405 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1426 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1431 | Argentina |
| Local Institution | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1034ACO | Argentina |
| Local Institution | České Budějovice | 370 01 | Czechia |
| Local Institution | Hradec Králové | 500 05 | Czechia |
| Local Institution | Prague | 128 50 | Czechia |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Chambray-lès-Tours | 37170 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Guadalajara | Jalisco | 44200 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44500 | Mexico |
| Local Institution | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution | Nuevo León | Nuevo León | 64020 | Mexico |
| Local Institution | Culiacán | Sinaloa | 8000 | Mexico |
| Local Institution | Cheonan | Choong Chung Nam-Do | 330-721 | South Korea |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Santiago de C. | 15706 | Spain |
| Local Institution | Vizcaya | 48903 | Spain |
| Local Institution | Taichung | B | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C552704 | 4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide |
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