Galvani Bioelectronics
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.
Rheumatoid Arthritis
Active Stimulation
Sham Stimulation
Baricitinib
Background Treatment
NA
Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1). Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks. At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks. Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 28 participants |
| Masking : | QUADRUPLE |
| Primary Purpose : | TREATMENT |
| Official Title : | Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis |
| Actual Study Start Date : | 2021-10-19 |
| Estimated Primary Completion Date : | 2027-07 |
| Estimated Study Completion Date : | 2032-04 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 22 Years to 75 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
WITHDRAWN
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
RECRUITING
Medvin Research - Covina
Covina, California, United States, 91722
RECRUITING
Medvin Research - Whittier
Whittier, California, United States, 90602
RECRUITING
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States, 21740
RECRUITING
NYU Langone
Brooklyn, New York, United States, 11201
RECRUITING
Oregon Health & Science University
Portland, Oregon, United States, 97239
RECRUITING
Altoona Center for Clinical Research
Altoona, Pennsylvania, United States, 16635
RECRUITING
Arthritis & Rheumatology Institute
Allen, Texas, United States, 75013
RECRUITING
St. David's Healthcare
Austin, Texas, United States, 78705
RECRUITING
Tekton Research
Austin, Texas, United States, 78745
WITHDRAWN
Metroplex Clinical Research Center
dallas, Texas, United States, 75231
RECRUITING
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
RECRUITING
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands,
RECRUITING
Maxima Medical Center, MMC
Eindhoven, Netherlands,