The research in the RESET-RA study will help determine if an investigational vagus nerve stimulation device is safe and can improve Rheumatoid Arthritis (RA) in patients who continue to experience symptoms even after having tried multiple medications.
Discovering new effective therapies for conditions like RA depends on clinical research. As participants in this study, the patients are partners in research and play an important role in advancing the treatment choices for RA.
The investigational device for the study is placed on the left vagus nerve through a small incision in the crease of the neck. The 60-90 minute implantation procedure is performed by an experienced surgeon while the patient is under general anesthesia. The patient typically returns home a few hours after the procedure and the healing process takes about 14-21 days.
WHO CAN PARTICIPATE IN THE STUDY?
Study participants must meet the following initial requirements in order to be further evaluated for participation:
Be 22-75 years of age
Have been diagnosed with RA as an adult
Have active moderate to severe RA
Are currently taking a conventional synthetic DMARD. Click here to see a list of common csDMARDs
Have received at least one biologic or targeted synthetic DMARD for RA that was either not effective or was not tolerable. Click here to see a list of common bDMARDs and tsDMARDs
Are willing to undergo an investigational vagus nerve stimulation implant procedure