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

Completed · Phase 3

Conditions studied: RA

In brief

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).

Key facts

Study ID

NCT02057250

Run by

Sanofi

People needed

217

Starts

2014-03-01

Expected to finish

2016-03-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840221 — Peoria, Arizona, United States
• Investigational Site Number 840226 — Roseville, California, United States
• Investigational Site Number 840223 — Boulder, Colorado, United States
• Investigational Site Number 840229 — Miami, Florida, United States
• Investigational Site Number 840236 — Orlando, Florida, United States
• Investigational Site Number 840155 — Palm Harbor, Florida, United States
• Investigational Site Number 840220 — South Miami, Florida, United States
• Investigational Site Number 840202 — Hagerstown, Maryland, United States
• Investigational Site Number 840232 — Flint, Michigan, United States
• Investigational Site Number 840233 — Kalamazoo, Michigan, United States
• Investigational Site Number 840037 — Tupelo, Mississippi, United States
• Investigational Site Number 840112 — Lincoln, Nebraska, United States
• Investigational Site Number 840039 — Albany, New York, United States
• Investigational Site Number 840224 — Cincinnati, Ohio, United States
• Investigational Site Number 840002 — Oklahoma City, Oklahoma, United States
• Investigational Site Number 840065 — Tulsa, Oklahoma, United States
• Investigational Site Number 840009 — Duncansville, Pennsylvania, United States
• Investigational Site Number 840062 — Reading, Pennsylvania, United States
• Investigational Site Number 840016 — North Charleston, South Carolina, United States
• Investigational Site Number 840025 — Jackson, Tennessee, United States
• Investigational Site Number 840038 — Austin, Texas, United States
• Investigational Site Number 840230 — Carrollton, Texas, United States
• Investigational Site Number 840001 — Dallas, Texas, United States
• Investigational Site Number 840020 — Houston, Texas, United States
• Investigational Site Number 840152 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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