Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

• Status: Recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

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 250 subjects at 40 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 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SetPoint Medical Corporation
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

• 22-75 years of age at screening

• Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints

• Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)

• Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

Exclusion Criteria:

• Untreated or poorly controlled psychiatric illness or history of substance abuse

• Significant immunodeficiency due to underlying illness

• History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia

• Clinically significant cardiovascular disease

• Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease

• Uncontrolled fibromyalgia

• History of left or right carotid surgery

• History of unilateral or bilateral vagotomy, partial or complete splenectomy

• Recurrent vasovagal syncope episodes

• Current, regular use of tobacco products

• Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI