CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 243 enrolled
Drug / intervention
Conventional Synthetic DMARD +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04539964
NCT04539964Phase 3Active
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Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study

SetPoint Medical Corporation·interventional·Posted Sep 7, 2020·Updated Apr 14, 2026

In Brief

A Phase 3 clinical trial evaluating Implant Procedure, Conventional Synthetic DMARD, and 2 other interventions for Rheumatoid Arthritis. Active but no longer recruiting, targeting 243 participants across 42 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3Active
2021202220232024202520262027
First PostedSep 7, 2020
Enrollment StartJan 11, 2021
Primary CompletionMay 16, 2024
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Interventions

Implant Procedureprocedure

The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.

Conventional Synthetic DMARDdrug

All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent

Active stimulationdevice

Active stimulation for 1 min once per day

Non-active stimulationdevice

Non-active stimulation for 1 min once per day