Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Īll subjects, investigators, joint evaluators and study staff will be blinded. Subjects assigned to the treatment group will receive active stimulation for 1 min once per day, and those assigned to the control group will receive non-active stimulation for 1 min once per day. Subjects will be assigned randomly in a 1:1 ratio into either a treatment or control group. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĪn operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter study. Blinding will be maintained until the last enrolled and randomized subject in Stage 2 completes Week 12 assessments, and the study database is locked.
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After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety. Stimulation will be delivered for 1 min once per day for 12 weeks. Half of the subjects will receive active stimulation (the treatment group) and the other half will receive non-active stimulation (the control group). All eligible subjects will undergo the surgery under general anesthesia. The implant delivers a small amount of electricity (stimulation) to the nerve. The study device contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). The study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The RESET-RA study is an operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter pivotal study enrolling 250 subjects at 40 study centers across the U.S. Procedure: Implant Procedure Drug: Conventional Synthetic DMARD Device: Active stimulation Device: Non-active stimulation
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Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). All eligible subjects will undergo the implant procedure. The study will enroll 250 subjects at 40 sites.
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The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Why Should I Register and Submit Results?.