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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.
This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | dose 1 vs. placebo |
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| 2 | Active Comparator | dose 2 vs. placebo |
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| 3 | Active Comparator | dose 3 vs. placebo |
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| 4 | Active Comparator | dose 4 vs. placebo |
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| 5 | Active Comparator | dose 5 vs. placebo |
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| 6 | Active Comparator | dose 6 vs. placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN88 | Biological | This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate exploratory efficacy endpoints | over 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Radin, MD | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Maria | California | United States | ||||
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| Boca Raton |
| Florida |
| United States |
| Clearwater | Florida | United States |
| Daytona Beach | Florida | United States |
| Delray Beach | Florida | United States |
| Palm Harbor | Florida | United States |
| Idaho Falls | Idaho | United States |
| Worcester | Massachusetts | United States |
| Lansing | Michigan | United States |
| Flowood | Mississippi | United States |
| Kalamzaoo | Missouri | United States |
| St Louis | Missouri | United States |
| Reno | Nevada | United States |
| Charlotte | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Duncansville | Pennsylvania | United States |
| Greenville | South Carolina | United States |
| Orangeburg | South Carolina | United States |
| Hixson | Tennessee | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | 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 |
|---|---|
| C000592401 | sarilumab |
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