The RESET-RA Study

Purpose: This is a research study to evaluate the safety and effectiveness of the SetPoint System vagal nerve stimulator (study device) for the treatment of patients with active, moderate-to-severe RA, who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).

Description: The study is a randomized, sham-controlled, double-blind, multicenter pivotal study enrolling up to 250 subjects ages 22-75 at 45 study centers across the U.S.  The goal is to evaluate the use of vagus nerve stimulation using a system designed by SetPoint Medical in patients will moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to 1 or more biologic or targeted synthetic disease-modifying anti-rheumatic drugs in hopes that this therapy will decrease inflammation. The device is implanted in the operating room. Within 14-21 days after implantation, patients are randomized 1:1 to either have the device activated or left non activated. Twelve weeks after randomization, the sham group (non-activated device patients), can be crossed over and have the device activated. Long term follow up is expected to last approximately 3.5 years for all patients after the crossover portion of the study.