Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT04539964

Run by

SetPoint Medical Corporation

People needed

243

Starts

2021-01-11

Expected to finish

2027-10-01

Last updated by the study team

2026-04-14

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22-75 years of age at screening
• Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
• Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
• Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

You may not qualify if…

• Untreated or poorly controlled psychiatric illness or history of substance abuse
• Significant immunodeficiency due to underlying illness
• History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
• Clinically significant cardiovascular disease
• Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
• Uncontrolled fibromyalgia
• History of left or right carotid surgery
• History of unilateral or bilateral vagotomy, partial or complete splenectomy
• Recurrent vasovagal syncope episodes
• Current, regular use of tobacco products
• Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI

Where it is running

• Arizona Arthritis ans Rheumatology Research, PPLC — Mesa, Arizona, United States
• Arizona Arthritis Rheumatology & Research, PLLC — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• Inland Rheumatology Clinical Trials — Upland, California, United States
• Medvin Clinical Research — Whittier, California, United States
• The Arthritis & Rheumatology Clinic of Northern Colorado — Fort Collins, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Delaware Arthritis — Lewes, Delaware, United States
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
• HARAC Research Corporation — Avon Park, Florida, United States
• RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida, United States
• Bay Area Rheumatology — Clearwater, Florida, United States
• IRIS Research and Development — Plantation, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Parris and Associates Rheumatology — Lawrenceville, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States
• Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology — Boston, Massachusetts, United States
• June DO, PC — Lansing, Michigan, United States
• Saint Paul Rheumatology, P.A. — Eagan, Minnesota, United States
• Kansas City Physician Partners — Kansas City, Missouri, United States
• West County Rheumatology — St Louis, Missouri, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Albuquerque Center for Rheumatology — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.