Rheumatoid Arthritis Clinical Trial
Official title:
An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
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). ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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