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Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
NCT04539964 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Conventional Synthetic DMARD
- PROCEDURE Implant Procedure
- DEVICE Active stimulation
- DEVICE Non-active stimulation
Study Locations (20)
Florida
- Arthritis & Rheumatic Disease Specialties — Aventura
- HARAC Research Corporation — Avon Park
- RecioMed Clinical Research Network, Inc. — Boynton Beach
- Bay Area Rheumatology — Clearwater
- IRIS Research and Development — Plantation
Arizona
- Arizona Arthritis ans Rheumatology Research, PPLC — Mesa
- Arizona Arthritis Rheumatology & Research, PLLC — Phoenix
- Arizona Arthritis & Rheumatology Research, PLLC — Tucson
California
- Medvin Clinical Research — Covina
- Inland Rheumatology Clinical Trials — Upland
- Medvin Clinical Research — Whittier
Georgia
- Augusta University — Augusta
- Parris and Associates Rheumatology — Lawrenceville
Illinois
- Northwestern University — Chicago
- Willow Rheumatology and Wellness PLLC — Willowbrook
Colorado
- The Arthritis & Rheumatology Clinic of Northern Colorado — Fort Collins
Connecticut
- Stamford Therapeutics Consortium — Stamford
Delaware
- Delaware Arthritis — Lewes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04539964
The ClinicalTrials.gov registry entry for NCT04539964 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SetPoint Medical Corporation, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions — of which Conventional Synthetic DMARD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04539964 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04539964 about?
NCT04539964 is a clinical study titled "Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis". 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 ...
What is the current status of trial NCT04539964?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2021-01-11. Estimated completion is 2027-10.
What conditions does trial NCT04539964 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04539964?
The interventions under investigation include: Conventional Synthetic DMARD (DRUG), Implant Procedure (PROCEDURE), Active stimulation (DEVICE), Non-active stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04539964?
This trial is sponsored by SetPoint Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04539964 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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