Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

Phase 3 Active, not recruiting NCT04539964

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.

the American College of Rheumatology (ACR) 20 Response

Week 12 · Participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• Dietary Salt in Rheumatoid Arthritis — Vanderbilt University Medical Center
• Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) — University of North Carolina, Chapel Hill
• Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With R — Alfasigma S.p.A.
• CD40L Antagonism in Rheumatoid Arthritis (RA) — National Institute of Allergy and Infectious Diseases (NIAID)
• A Study of Baricitinib in Participants With Rheumatoid Arthritis — Eli Lilly and Company
• A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis — Eli Lilly and Company

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