Clinical trialNCT04539964Active, not recruitingPhase 3Interventional

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

SponsorSetPoint Medical CorporationEnrollment243Rheumatoid Arthritis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

John Tesser, MD
Arizona Arthritis and Rheumatology Research, P.C.
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Mark Richardson, MD PhD
Massachusetts General Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Long Island Regional Arthritis & Osteoporosis Care
Babylon, New York, United States
Arthritis & Osteoporosis Consultants of the Carolinas
Charleston, North Carolina, United States
Djl Clinical Research
Charlotte, North Carolina, United States
Health Research of Oklahoma, Pllc
Oklahoma City, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Arthritis & Rheumatology Research Institute, Pllc
Allen, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Central Texas Rheumatology Associates
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Biopharma Informatic
Houston, Texas, United States
Southwest Rheumatology Research Llc
Mesquite, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Annapolis Rheumatology
Fairfax, Virginia, United States

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Conventional Synthetic DMARD

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Jan 2021
Primary completion: 16 May 2024
Completion: 31 Oct 2027
Last update posted: 14 Apr 2026
Registered enrollment: 243
Registry id: NCT04539964

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.