NCT02404558

Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	sarilumab SAR153191 (REGN88)	Pharmaceutical form:solution Route of administration: Subcutaneous injection
DRUG	tocilizumab	Pharmaceutical form:solution Route of administration: Subcutaneous injection

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-03-31
• Last updated: 2016-03-28

Locations

3 sites across 1 country: Japan