Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (NCT04539964)
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Arthritis ans Rheumatology Research, PPLC — Mesa, Arizona
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (42 Sites)
Showing the first 25 of 42 sites.
- Arizona Arthritis ans Rheumatology Research, PPLC — Mesa, Arizona
- Arizona Arthritis Rheumatology & Research, PLLC — Phoenix, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona
- Medvin Clinical Research — Covina, California
- Inland Rheumatology Clinical Trials — Upland, California
- Medvin Clinical Research — Whittier, California
- The Arthritis & Rheumatology Clinic of Northern Colorado — Fort Collins, Colorado
- Stamford Therapeutics Consortium — Stamford, Connecticut
- Delaware Arthritis — Lewes, Delaware
- Arthritis & Rheumatic Disease Specialties — Aventura, Florida
- HARAC Research Corporation — Avon Park, Florida
- RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida
- Bay Area Rheumatology — Clearwater, Florida
- IRIS Research and Development — Plantation, Florida
- Augusta University — Augusta, Georgia
- Parris and Associates Rheumatology — Lawrenceville, Georgia
- Northwestern University — Chicago, Illinois
- Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois
- Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology — Boston, Massachusetts
- June DO, PC — Lansing, Michigan
- Saint Paul Rheumatology, P.A. — Eagan, Minnesota
- Kansas City Physician Partners — Kansas City, Missouri
- West County Rheumatology — St Louis, Missouri
- Physician Research Collaboration, LLC — Lincoln, Nebraska
- Albuquerque Center for Rheumatology — Albuquerque, New Mexico
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rheumatoid Arthritis
- Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD — Phoenix, Arizona
- A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis. — Santa Monica, California
- Employment and Arthritis: Making it Work — Richmond, British Columbia
- Brigham and Women's Rheumatoid Arthritis Sequential Study — Boston, Massachusetts
- A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) — Flagstaff, Arizona
- A Study of SPY072 in Rheumatic Disease — Avondale, Arizona
Explore by condition: All Rheumatoid Arthritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.