Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis

What this Trial Is About

This research aims to evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle using the Galvani System in people with active rheumatoid arthritis RA. Participants must have active RA with an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs DMARDs or JAK inhibitors. The study includes four distinct periods a randomized control trial, an open label phase, a treat-to-target phase, and a long-term follow-up, to thoroughly assess the treatment over time. Participants who receive the implantable system will be randomly assigned to either active stimulation or sham stimulation for 12 weeks in the first period. In the second period, responders to stimulation continue it, while non-responders or those who had sham stimulation receive an approved RA drug, baricitinib, for 12 weeks. In the third period, participants showing improvement but still with RA symptoms receive combined therapy of stimulation and baricitinib for up to 24 weeks. The fourth period provides a long-term safety follow-up lasting up to 5 years, during which participants may receive stimulation with other standard treatments as judged appropriate. Throughout the study, participants will undergo assessments including monitoring for adverse events, changes in RA disease activity scores, inflammatory markers, and questionnaires on physical and mental health. The study will track safety and tolerability during each period, with long-term follow-up to observe ongoing effects. The total participation duration extends over several years, with detailed monitoring to evaluate the implantable devices performance and impact on RA symptoms.

ConsideRAte Study - Splenic Stimulation for RA