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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1163-1359 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).
Secondary Objectives:
To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.
To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarilumab | Experimental | Single subcutaneous (SC) dose of sarilumab |
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| Tocilizumab | Active Comparator | Single SC dose of tocilizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sarilumab SAR153191 (REGN88) | Drug | Pharmaceutical form:solution Route of administration: Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with adverse events | 6 weeks | |
| Percentage of patients with potentially clinically significant laboratory abnormalities | 6 weeks | |
| Change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 15 | |
| Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter: maximum concentration (Cmax) | Day 1 to Day 43 | |
| Assessment of PK parameter: time to Cmax (tmax) | Day 1 to Day 43 | |
| Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392001 | Sendai | Japan | ||||
| Investigational Site Number 392002 |
| 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. |
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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 |
| C502936 | tocilizumab |
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| tocilizumab | Drug | Pharmaceutical form:solution Route of administration: Subcutaneous injection |
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| Day 1 to Day 43 |
| Change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 29 and Day 43 |
| Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 29 and Day 43 |
| Sendai |
| Japan |
| Investigational Site Number 392003 | Sendai | Japan |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |