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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.
This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.
Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | First dose of SC REGN88 |
|
| Dose 2 | Experimental | Second dose of SC REGN88 |
|
| Dose 3 | Experimental | Third dose of SC REGN88 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN88 | Biological | Single SC Dose |
| |
| REGN88 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate | 113 Days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88 | 113 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Radin, M.D. | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duncansville | Pennsylvania | United States | ||||
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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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| Biological |
Single SC Dose |
|
| REGN88 | Biological | Single SC Dose |
|
| Dallas |
| Texas |
| United States |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |