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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: sarilumab SAR153191 (REGN88); Drug: tocilizumab

• Registration Number: NCT02404558
• Lead Sponsor: Sanofi

Brief 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).

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Study Start: 2015-05
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarilumab	sarilumab SAR153191 (REGN88)	Single subcutaneous (SC) dose of sarilumab
Tocilizumab	tocilizumab	Single SC dose of tocilizumab

Primary Outcome Measures

Name	Time	Method
Percentage of patients with adverse events	6 weeks
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)	Baseline, Day 15
Percentage of patients with potentially clinically significant laboratory abnormalities	6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)	Baseline, Day 15

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: maximum concentration (Cmax)	Day 1 to Day 43
Change from baseline in laboratory parameters (hematology and biochemistry)	Baseline, Day 29 and 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)	Day 1 to Day 43
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)	Baseline, Day 29 and Day 43

Trial Locations

Locations (3)

Investigational Site Number 392001; 🇯🇵 Sendai-Shi, Japan

Investigational Site Number 392002; 🇯🇵 Sendai-Shi, Japan

Investigational Site Number 392003; 🇯🇵 Sendai-Shi, Japan