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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo).
Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental |
| |
| Dose 2 | Experimental |
| |
| Dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN475 | Drug | 2 Administrations of REGN475 within 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) (total score as well as all 3 subscales: pain, stiffness and function). | 24 weeks | |
| Patient assessment of response to treatment over time using the Patient Global Impression of Change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States | ||||
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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| Placebo | Other | Placebo to match REGN475 doses |
|
| 24 weeks |
| Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12). | 24 weeks |
| Tampa |
| Florida |
| United States |
| Salt Lake City | Utah | United States |
| D012216 |
| Rheumatic Diseases |