ConsideRAte Study - Splenic Stimulation for RA
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT05003310
- Run by
- Galvani Bioelectronics
- People needed
- 28
- Starts
- 2021-10-19
- Expected to finish
- 2032-04-01
- Last updated by the study team
- 2024-05-22
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Maxima Medical Center, MMC — Eindhoven, Netherlands (enrolling)
- Medvin Research - Covina — Covina, California, United States (enrolling)
- Medvin Research - Whittier — Whittier, California, United States (enrolling)
- The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland, United States (enrolling)
- NYU Langone — Brooklyn, New York, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Altoona Center for Clinical Research — Altoona, Pennsylvania, United States (enrolling)
- Arthritis & Rheumatology Institute — Allen, Texas, United States (enrolling)
- St. David's Healthcare — Austin, Texas, United States (enrolling)
- Tekton Research — Austin, Texas, United States (enrolling)
- Southwest Rheumatology Research — Mesquite, Texas, United States (enrolling)
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology — Amsterdam, Netherlands (enrolling)
- Metroplex Clinical Research Center — Dallas, Texas, United States
- Pinnacle Research Group, LLC — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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