ConsideRAte Study - Splenic Stimulation for RA
Recruiting · NCT05003310 · Interventional (participants receive a specific treatment) · Lead sponsor: Galvani Bioelectronics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 disease or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
- Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
- Previous splenectomy
Where it is running
14 locations listed across 7 US states.
- 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