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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Investigational Site Number 392001
Sendai, Japan
Investigational Site Number 392002
Sendai, Japan
Investigational Site Number 392003
Sendai, Japan
Percentage of patients with adverse events
Time frame: 6 weeks
Percentage of patients with potentially clinically significant laboratory abnormalities
Time frame: 6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 15
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 15
Assessment of PK parameter: maximum concentration (Cmax)
Time frame: Day 1 to Day 43
Assessment of PK parameter: time to Cmax (tmax)
Time frame: Day 1 to Day 43
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Time frame: Day 1 to Day 43
Change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 29 and Day 43
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 29 and Day 43
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