Tests electrical stimulation of the spleen nerves in rheumatoid arthritis
Tests a implanted device stimulating spleen nerves in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: ConsideRAte Study - Splenic Stimulation for RA
Key facts
- Where
- Amsterdam and Eindhoven, NetherlandsSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT05003310, who can take part
Where in Netherlands
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical ImmunologyAmsterdam, NetherlandsTaking people
- Maxima Medical Center, MMCEindhoven, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Galvani Bioelectronics
- Trial code
- NCT05003310
- Record updated
- 22 May 2024
- Original description
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.Read full original descriptionShow less
Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
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.
Inclusion: 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: Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B; Previous splenectomy; Significant psychiatric disease or substance abuse; History of unilateral or bilateral vagotomy; Active or latent tuberculosis; 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); Inability to provide informed consent.