To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

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

Summary

Primary Objective:

To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Hydroxychloroquine; Leflunomide; Methotrexate; Sulfasalazine

Criteria

Inclusion criteria:

• Diagnosis of RA, ≥3 months disease duration;

• Participant willing and able to self-inject;

• Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);

• Moderate-to-severely active RA.

Exclusion criteria:

• Participants <18 years;

• Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;

• Treatment with tumor necrosis factor (TNF) antagonists;

• Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;

• Prior treatment with a Janus kinase inhibitor.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.