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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarilumab - dose 1 | Experimental | Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice) |
|
| Sarilumab - dose 2 | Experimental | Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice) |
|
| Tocilizumab - dose 1 | Active Comparator | Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice) |
|
| Tocilizumab - dose 2 | Active Comparator | Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarilumab | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| PD parameters | Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4:
| baseline through week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of TEAEs | Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6). | baseline through week 6 |
| PK parameters | Pharmacokinetic (PK) parameters, what the body does to a drug, will be collected from baseline through week 4:
|
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Inclusion Criteria:
Exclusion Criteria:
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32453485 | Derived | Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20. | |
| 30590833 |
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| Tocilizumab |
| Drug |
|
| baseline through week 4 |
| Orange |
| California |
| United States |
| DeLand | Florida | United States |
| Edgewater | Florida | United States |
| Miami | Florida | United States |
| Miami Lakes | Florida | United States |
| Granger | Indiana | United States |
| Grand Blanc | Michigan | United States |
| Charlotte | North Carolina | United States |
| Cinicinnati | Ohio | United States |
| Memphis | Tennessee | United States |
| Austin | Texas | United States |
| Carrollton | Texas | United States |
| Channelview | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Mesquite | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| Derived |
| Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A. Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 May 1;58(5):849-858. doi: 10.1093/rheumatology/key361. |
| 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 |
| C502936 | tocilizumab |
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