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

Sponsor
Sanofi
Study ID
NCT02404558
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sarilumab SAR153191 (REGN88) — DRUG
    Pharmaceutical form:solution Route of administration: Subcutaneous injection
  • tocilizumab — DRUG
    Pharmaceutical form:solution Route of administration: Subcutaneous injection

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Mar 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sarilumab
    Single subcutaneous (SC) dose of sarilumab
  • Active Comparator: Tocilizumab
    Single SC dose of tocilizumab

Primary Outcome Measure

Percentage of patients with adverse events [ Time Frame: 6 weeks ]

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