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

NCT02057250

CompletedPhase 3

Sponsor: Sanofi

Conditions: RA

Interventions: Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS), Methotrexate, Sulfasalazine

Countries: United States, Chile, Mexico, Poland, Russia, South Africa

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (53)

Huntsville, Alabama, United States
Peoria, Arizona, United States
Roseville, California, United States
Boulder, Colorado, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
South Miami, Florida, United States
Hagerstown, Maryland, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Tupelo, Mississippi, United States
Lincoln, Nebraska, United States
Albany, New York, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Reading, Pennsylvania, United States
North Charleston, South Carolina, United States
Jackson, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
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