Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2261003 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emergent Product Development Seattle LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental |
| |
| Treatment Group 2 | Experimental |
| |
| Treatment Group 3 | Experimental |
| |
| Treatment Group 4 | Experimental |
| |
| Treatment Group 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBI-087 | Drug | 200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response as measured by American College of Rheumatology criteria (ACR 20 response) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response | up to 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Paradise Valley | Arizona | 85253 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| SBI-087 |
| Drug |
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate |
|
| SBI-087 | Drug | 200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate |
|
| SBI-087 | Drug | 200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate |
|
| Placebo | Drug | Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
|
| Palm Desert |
| California |
| 92260 |
| United States |
| Pfizer Investigational Site | Santa Monica | California | 90404 | United States |
| Pfizer Investigational Site | Westlake Village | California | 91361 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19713 | United States |
| Pfizer Investigational Site | Miami | Florida | 33169 | United States |
| Pfizer Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62704 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01610 | United States |
| Pfizer Investigational Site | Grand Rapids | Michigan | 49546 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Syracuse | New York | 13210 | United States |
| Pfizer Investigational Site | Minot | North Dakota | 58701 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45408 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43606 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29406 | United States |
| Pfizer Investigational Site | Jackson | Tennessee | 38305 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99204 | United States |
| Pfizer Investigational Site | Clarksburg | West Virginia | 26301 | United States |
| Pfizer Investigational Site | Buenos Aires | C.a.b.a. | C1015ABO | Argentina |
| Pfizer Investigational Site | C.a.b.a | C1055AAF | Argentina |
| Pfizer Investigational Site | C.a.b.a | C1425EKG | Argentina |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9L 3A2 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Pfizer Investigational Site | Providencia | Santiago Metropolitan | 7601126 | Chile |
| Pfizer Investigational Site | Budapest | 1023 | Hungary |
| Pfizer Investigational Site | Gyula | 5701 | Hungary |
| Pfizer Investigational Site | Miskolc | 3529 | Hungary |
| Pfizer Investigational Site | Szolnok | 5000 | Hungary |
| Pfizer Investigational Site | Aichi | Japan |
| Pfizer Investigational Site | Fukui | Japan |
| Pfizer Investigational Site | Fukuoka | Japan |
| Pfizer Investigational Site | Hokkaido | Japan |
| Pfizer Investigational Site | Hyōgo | Japan |
| Pfizer Investigational Site | Kanagawa | Japan |
| Pfizer Investigational Site | Miyagi | Japan |
| Pfizer Investigational Site | Saitama | Japan |
| Pfizer Investigational Site | Shizuoka | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| Pfizer Investigational Site | Coahulia | Torreon | 27000 | Mexico |
| Pfizer Investigational Site | Warsaw | Poland | 04-141 | Poland |
| Pfizer Investigational Site | Działdowo | 13-200 | Poland |
| Pfizer Investigational Site | Elblag | 82-300 | Poland |
| Pfizer Investigational Site | Sopot | 81-759 | Poland |
| Pfizer Investigational Site | Warsaw | 02-637 | Poland |
| Pfizer Investigational Site | Belgrade | 11000 | Serbia |
| Pfizer Investigational Site | Niška Banja | 18205 | Serbia |
| Pfizer Investigational Site | Novi Sad | 21000 | Serbia |
| Pfizer Investigational Site | A Coruña | A Coruña | 15006 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28007 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41009 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622592 | SBI-087 |
Not provided
Not provided
Not provided