This study will evaluate the safety, tolerability, and effects of stimulating the splenic
neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable
pulse generator, external components and accessories. The study will consist of 4 study
periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period
2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4).
Participants eligible for implant will have active rheumatoid arthritis (RA) and have an
inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic
Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be
enrolled so that approximately 28 participants will undergo device implantation.