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The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablet, once daily for 4 weeks |
| |
| PH-797804 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85013 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
Tablet, 1 mg PH-797804, once daily for 4 weeks |
|
| PH-797804 | Drug | Tablet, 5 mg PH-797804, once daily for 4 weeks |
|
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| Pfizer Investigational Site | Miami | Florida | 33169 | United States |
| Pfizer Investigational Site | Frederick | Maryland | 21702 | United States |
| Pfizer Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| 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 |
|---|---|
| C542398 | PH 797804 |
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