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The purpose of this clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-582949 and Methotrexate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state | during 28 doses of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949 | ||
| To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone | during 28 days of treatment |
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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 | ||
| Boling Clinical Trials |
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| To evaluate PK of MTX in stable RA subjects in the absence and presence of BMS-582949 for subjects enrolled prior to approval of amendment 2 |
| Upland |
| California |
| 91786 |
| United States |
| Delray Research Associates | Delray Beach | Florida | 33484 | United States |
| Ocala Rheumatology Research Center | Ocala | Florida | 34474 | United States |
| Phase Iii Clinical Research | Fall River | Massachusetts | 02720 | United States |
| Covance Clinical Research Unit Inc. | Dallas | Texas | 75247 | United States |
| Radiant Research San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Healthcare Discoveries, Inc | San Antonio | Texas | 78229 | United States |
| Local Institution | León | Guanajuato | 37520 | Mexico |
| Local Institution | Metepec | State of Mexico | 52140 | Mexico |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| 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 |
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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 |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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