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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion criteria:

• Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010

• Rheumatoid Arthritis Classification Criteria.

• ACR Class I-III functional status, based on the 1991 revised criteria.

Exclusion criteria:

• Patients less than 20 years of age.

• Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.

• Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.

• Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.

• Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.

• Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.

• Active or suspected tuberculosis (TB) or at high risk of contracting TB.

• Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.