RESET-RA Study

Study of an investigational device for patients with rheumatoid arthritis (Recruitment complete)

Type

Interventional – treatment

The study device is implanted on the vagus nerve and may decrease inflammatory markers to reduce symptoms in people with rheumatoid arthritis (RA). The device is investigational for use in patients with RA.

Purpose

The research in the RESET-RA study will help determine if an investigational vagus nerve stimulation device is safe and can improve RA in patients who continue to experience symptoms even after having tried multiple medications. Although there is no guarantee that participation will benefit you, this study has an important role in advancing treatment choices for RA and may help future patients.

Eligibility

You may be eligible for this study if you:

  • Are aged 22-75;
  • Have been diagnosed with rheumatoid arthritis as an adult;
  • Have active, moderate to severe RA;
  • Are currently taking a conventional synthetic DMARD;
  • Have received at least one biologic or targeted synthetic DMARD for RA that was either not effective or was not tolerable; and
  • Are willing to undergo an investigational vagus nerve stimulation implant procedure.

Participation

All participants undergo the implant procedure, which will be performed by a surgeon with extensive experience in this specific type of procedure. You will be randomized either to receive active stimulation (treatment group) or to receive non-active doses of stimulation (control group) for the first 12 weeks after implantation. Regardless of your randomization, you will continue using a conventional DMARD throughout the study and receive usual care.

After the 12-week period, if you were in the control group, you can cross over to receive active stimulation. You may also choose to discontinue use of the device. The long-term phase will last approximately three years, and the study team will assess your RA progress and general health. During this time, you can also add biologic DMARDs, according to your doctor’s recommendation.