Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
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). 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 study will
enroll 250 subjects at 40 sites. All eligible subjects will undergo the implant procedure.
Half of the subjects will receive active stimulation (treatment) and the other half will
receive non-active stimulation (control). 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.