NCT05003310Recruiting
ConsideRAte Study - Splenic Stimulation for RA
Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 22 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 5 Jul 2021
- Start date
- 19 Oct 2021
- Primary completion date
- Jul 2027
- Lead sponsor
- Galvani Bioelectronics
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05003310
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 19 Oct 2021 to the primary completion date, Jul 2027
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
- Previous splenectomy
Other illness
- 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)
Other
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Maxima Medical Center, MMC Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Arthritis & Rheumatology Institute Coordinator of this site? Confirm its status | Allen | United States | Recruiting |
| Altoona Center for Clinical Research Coordinator of this site? Confirm its status | Altoona | United States | Recruiting |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Withdrawn |
| St David's HealthCare Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Tekton Research Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| NYU Langone Coordinator of this site? Confirm its status | Brooklyn | United States | Recruiting |
| Medvin Research - Covina Coordinator of this site? Confirm its status | Covina | United States | Recruiting |
| Metroplex Clinical Research Center Coordinator of this site? Confirm its status | Dallas | United States | Withdrawn |
| The Osteoporosis & Clinical Trials Center Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Southwest Rheumatology Research Coordinator of this site? Confirm its status | Mesquite | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Medvin Research - Whittier Coordinator of this site? Confirm its status | Whittier | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.