Vagus Nerve Stimulation for Rheumatoid Arthritis

(RESET-RA Trial)

Recruiting at45 trial locations

Overseen by JOHN R TESSER

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: SetPoint Medical Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 up to 250 subjects at up to 45 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 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

Research Team

JOHN R TESSER

Principal Investigator

Arizona Arthritis and Rheumatology Research, P.C.

Mark Richardson, MD PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults aged 22-75 with active, moderate to severe rheumatoid arthritis who haven't responded well or can't tolerate certain advanced RA medications. Participants must be on a stable dose of conventional synthetic DMARD for at least 12 weeks before the trial and continue it through Week 12. People with recurrent fainting episodes, significant psychiatric or substance abuse history, stroke/TIA, serious heart disease, neurological disorders like MS/Alzheimer's/Parkinson's, uncontrolled fibromyalgia, past carotid surgery/splenectomy/vagotomy or tobacco users are excluded.

Inclusion Criteria

I have rheumatoid arthritis and treatments like biologics or JAK inhibitors haven’t worked for me.

I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.

I have been on a stable dose of a DMARD for my condition for at least 12 weeks.

Exclusion Criteria

I have a condition that significantly weakens my immune system.

I frequently faint due to sudden drops in my heart rate and blood pressure.

I have had surgery on my carotid artery.

Treatment Details

Interventions

• SetPoint System (Device)

Trial Overview The RESET-RA study is testing the SetPoint System device that stimulates the vagus nerve to treat rheumatoid arthritis. The device is implanted via surgery under general anesthesia. Of the enrolled participants, half will receive actual stimulation while the other half will get non-active stimulation as a control group initially; after Week 12 all subjects will receive active stimulation for long-term safety assessment.

Participant Groups

Group I: Treatment Experimental Treatment 3 Interventions

Active stimulation for 1 min once per day

Group II: Control Placebo Group 3 Interventions

Non-active stimulation for 1 min once per day

Who Is Running the Clinical Trial?

SetPoint Medical Corporation

Lead Sponsor

Trials

8

Recruited

400+