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NCT04539964 · ClinicalTrials.gov registry record · Phase 3
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
A Phase 3 study of Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation.
- Active
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
- 20
- Study locations
NCT04539964: Active Phase 3 study of Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation.
NCT04539964 is a Phase 3 study of Rheumatoid Arthritis that is active but no longer recruiting, run by SetPoint Medical Corporation. The registered enrollment target is 243 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04539964, a Phase 3 study of Rheumatoid Arthritis, is active but no longer recruiting, sponsored by SetPoint Medical Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 243 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentrati
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 |
What the registry record for NCT04539964 still lists
NCT04539964 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower).
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.
NCT04539964 names 20 study sites across 10 states, led by Florida, Arizona, California.
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.
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).
Who is sponsoring clinical trial NCT04539964?
This trial is sponsored by SetPoint Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04539964's enrollment target sits among peer trials
243 75th of 197 higher than 123 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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