ConsideRAte Study - Splenic Stimulation for RA
Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
Galvani Bioelectronics
28 participants
Oct 19, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
Stimulation will be turned ON and applied during each day of the period.
Sham stimulation will be provided during the period
Baricitinib (2 mg) is administered daily during the period.
Stable dose of standard background treatment (e.g., csDMARD therapy)
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT05003310