Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

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

• Rheumatoid Arthritis

Interventions

PROCEDURE

Implant Procedure

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.

DRUG

Conventional Synthetic DMARD

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

DEVICE

Active stimulation

Active stimulation for 1 min once per day

DEVICE

Non-active stimulation

Non-active stimulation for 1 min once per day

Sponsors & Collaborators

• SetPoint Medical Corporation

  lead INDUSTRY

Principal Investigators

• John Tesser, MD · Arizona Arthritis and Rheumatology Research, P.C.

• Mark Richardson, MD PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-11

Primary Completion

2024-05-16

Completion

2027-10-31

FDA Device

Yes

Countries

• United States

Study Locations