Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
Galvani Bioelectronics
Summary
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.
Description
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…
Eligibility
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * RA of at least six months duration, per 2010 ACR/EULAR criteria * Male or female participants, 22-75 years of age * Active RA * Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor * Have an appropriate washout from previously used biological DMARDs or JAKi * Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance Exclusion Criteria: * Inability to provide informed consent * Significant psychiatric dise…
Interventions
- DeviceActive Stimulation
Stimulation will be turned ON and applied during each day of the period.
- DeviceSham Stimulation
Sham stimulation will be provided during the period
- DrugBaricitinib
Baricitinib (2 mg) is administered daily during the period.
- DrugBackground Treatment
Stable dose of standard background treatment (e.g., csDMARD therapy)
Locations (14)
- Pinnacle Research Group, LLCAnniston, Alabama
- Medvin Research - CovinaCovina, California
- Medvin Research - WhittierWhittier, California
- The Osteoporosis & Clinical Trials CenterHagerstown, Maryland
- NYU LangoneBrooklyn, New York
- Oregon Health & Science UniversityPortland, Oregon