Exploratory Study Evaluating Splenic Nerve Stimulation Using the Galvani System for Rheumatoid Arthritis Patients with Inadequate Response to Biologic or JAK Inhibitors Including Randomized, Open-Label, Treat-to-Target, and Long-Term Follow-Up Periods

What this Trial Is About

Researchers are studying the safety, tolerability, and effects of stimulating the splenic neurovascular bundle using the Galvani System, which includes an implantable lead and pulse generator along with external components. This research focuses on adults with active rheumatoid arthritis (RA) who have not responded well or are intolerant to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors. Approximately 28 participants will receive the device implantation to evaluate its impact. Participants with active RA who receive the implant will be randomly assigned to either active stimulation or sham stimulation for a 12-week period (Period 1). After this, all participants enter an open-label phase (Period 2) lasting 12 weeks, where responders to stimulation continue it, and others receive an approved RA medication. Those still showing RA symptoms after Period 2 enter a Treat-to-Target phase (Period 3), receiving combined stimulation and medication for up to 24 weeks. Finally, Period 4 offers a long-term safety follow-up for up to 5 years, allowing ongoing stimulation and standard RA treatments as judged appropriate. During the study, participants will be monitored for safety and treatment-emergent adverse events across all four periods. Researchers will assess responses through clinical evaluations and safety checks up to 5 years after implantation. The study tracks adverse events during each period, ensuring careful observation of participant health and treatment effects throughout the entire study duration.

ConsideRAte Study - Splenic Stimulation for RA