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This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0360324 | Drug | 3 doses of PD 0360324 (Dose level 1) administered over 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety laboratories | 16 weeks | |
| Vital signs | 16 weeks | |
| ECG | 16 weeks | |
| Incidence and severity of adverse events | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | 16 weeks | |
| Pharmacodynamic | 16 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 | Peoria | Arizona | 85381 | 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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| PD 0360324 |
| Drug |
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks |
|
| PD 0360324 | Drug | 3 doses of PD 0360324 (Dose level 3) administered over 12 weeks |
|
| Placebo | Drug | 3 doses of Placebo administered over 12 weeks |
|
| Daytona Beach |
| Florida |
| 32114 |
| United States |
| Pfizer Investigational Site | Port Orange | Florida | 32127 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Frederick | Maryland | 21702 | United States |
| Pfizer Investigational Site | Lansing | Michigan | 48910-8595 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Buenos Aires | C1013AAR | Argentina |
| Pfizer Investigational Site | Pleven | 5800 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1606 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1612 | Bulgaria |
| Pfizer Investigational Site | Brno | 656 91 | Czechia |
| Pfizer Investigational Site | Prague | 140 59 | Czechia |
| Pfizer Investigational Site | México | D.F. | 06700 | Mexico |
| Pfizer Investigational Site | Mexico City | Mexico City | 14050 | Mexico |
| Pfizer Investigational Site | Bialystok | 15-461 | Poland |
| Pfizer Investigational Site | Bialystok | 15-875 | Poland |
| Pfizer Investigational Site | Krakow | 31-201 | Poland |
| Pfizer Investigational Site | Krakow | 31-752 | Poland |
| Pfizer Investigational Site | Warsaw | 02-637 | Poland |
| Pfizer Investigational Site | Wroclaw | 51-124 | Poland |
| Pfizer Investigational Site | Piešťany | 921 01 | Slovakia |
| Pfizer Investigational Site | Santiago de Compostela | A CORUÑA | 15705 | Spain |
| 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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