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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Active dose |
|
| Dose 2 | Experimental | Active dose |
|
| Dose 3 | Experimental | Active 3 |
|
| Dose 4 | Placebo Comparator | Placebo dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN88 | Drug | Single dose of REGN88 and 43 day follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hs-C reactive protein (hs-CRP) | 43 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Assessment of Pain and Subject's Global Assessment of Disease activity | 43 Days |
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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 |
|---|---|---|---|---|---|---|
| Institute of Rheumatology under the Russian Academy of Medical Sciences | Moscow | Russia |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000592401 | sarilumab |
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| Placebo | Other | Placebo to match REGN88 administration |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |