Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT04539964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04539964
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 243 participants
Conditions and interventions
Conditions
Interventions
- Implant Procedure Procedure
- Conventional Synthetic DMARD Drug
- Active stimulation Device
- Non-active stimulation Device
Procedure · Drug · Device
Eligibility (public fields only)
- Age range
- 22 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2021 (Actual)
- Primary completion
- May 16, 2024 (Actual)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Apr 14, 2026
2021 – 2027
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis ans Rheumatology Research, PPLC | Mesa | Arizona | 85210 | — |
| Arizona Arthritis Rheumatology & Research, PLLC | Phoenix | Arizona | 85037 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Tucson | Arizona | 85704 | — |
| Medvin Clinical Research | Covina | California | 91722 | — |
| Inland Rheumatology Clinical Trials | Upland | California | 91786 | — |
| Medvin Clinical Research | Whittier | California | 90602 | — |
| The Arthritis & Rheumatology Clinic of Northern Colorado | Fort Collins | Colorado | 80528 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Delaware Arthritis | Lewes | Delaware | 19958 | — |
| Arthritis & Rheumatic Disease Specialties | Aventura | Florida | 33180 | — |
| HARAC Research Corporation | Avon Park | Florida | 33825 | — |
| RecioMed Clinical Research Network, Inc. | Boynton Beach | Florida | 33472 | — |
| Bay Area Rheumatology | Clearwater | Florida | 33765 | — |
| IRIS Research and Development | Plantation | Florida | 33324 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Parris and Associates Rheumatology | Lawrenceville | Georgia | 30044 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Willow Rheumatology and Wellness PLLC | Willowbrook | Illinois | 60527 | — |
| Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology | Boston | Massachusetts | 02114 | — |
| June DO, PC | Lansing | Michigan | 48910 | — |
| Saint Paul Rheumatology, P.A. | Eagan | Minnesota | 55121 | — |
| Kansas City Physician Partners | Kansas City | Missouri | 64151 | — |
| West County Rheumatology | St Louis | Missouri | 63122 | — |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | — |
| Albuquerque Center for Rheumatology | Albuquerque | New Mexico | 87102 | — |
| Long Island Regional Arthritis & Osteoporosis Care | Babylon | New York | 11702 | — |
| Arthritis & Osteoporosis Consultants Of The Carolinas | Charleston | North Carolina | 28202 | — |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | — |
| Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Arthritis & Rheumatology Research Institute, PLLC | Allen | Texas | 75013 | — |
| Austin Regional Clinic | Austin | Texas | 78717 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Central Texas Rheumatology Associates | Austin | Texas | 78746 | — |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | — |
| Biopharma Informatic | Houston | Texas | 77043 | — |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | — |
| Clinical Trials of Texas, Inc | San Antonio | Texas | 78229 | — |
| Annapolis Rheumatology | Fairfax | Virginia | 22033 | — |
| Sound Clinical Research, LLC | Bothell | Washington | 98021 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04539964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04539964 live on ClinicalTrials.gov.