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ConsideRAte Study - Splenic Stimulation for RA
Sponsor: 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.
Official title: Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2021-10-19
Completion Date
2032-04
Last Updated
2024-05-22
Healthy Volunteers
No
Conditions
Interventions
Active Stimulation
Stimulation will be turned ON and applied during each day of the period.
Sham Stimulation
Sham stimulation will be provided during the period
Baricitinib
Baricitinib (2 mg) is administered daily during the period.
Background Treatment
Stable dose of standard background treatment (e.g., csDMARD therapy)
Locations (14)
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Medvin Research - Covina
Covina, California, United States
Medvin Research - Whittier
Whittier, California, United States
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States
NYU Langone
Brooklyn, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Altoona Center for Clinical Research
Altoona, Pennsylvania, United States
Arthritis & Rheumatology Institute
Allen, Texas, United States
St. David's Healthcare
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Southwest Rheumatology Research
Mesquite, Texas, United States
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands
Maxima Medical Center, MMC
Eindhoven, Netherlands