Evaluating the safety of splenic stimulation for rheumatoid arthritis
A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device
This study is testing a new device that stimulates the spleen to see if it can safely help people with rheumatoid arthritis who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Galvani Bioelectronics Industry-sponsored |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT04955899 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the Galvani neuromodulation system, which stimulates the splenic neurovascular bundle in patients with active rheumatoid arthritis (RA). Participants who have not responded adequately to at least two biologic DMARDs or JAK inhibitors will be implanted with the device and receive neurostimulation for a duration of 12 weeks. The study will involve a total of five participants, with follow-up visits scheduled throughout the treatment period to monitor their response and adjust stimulation parameters if necessary. After the treatment phase, participants will have the option to enroll in a long-term follow-up study lasting up to five years.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 22-75 with active rheumatoid arthritis who have had inadequate responses to at least two biologic DMARDs or JAK inhibitors.
Not a fit: Patients with significant psychiatric disorders, those with a history of vagotomy, or individuals currently using other electrically active medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new therapeutic option for patients with rheumatoid arthritis who have not responded to existing treatments.
How similar studies have performed: While this approach is novel, similar neuromodulation techniques have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult-onset RA of at least six months duration * Male or female participants, 22-75 years of age * Active RA * Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis) * Have an appropriate washout from previously used biological DMARDs or JAKi * A female participant should have no child-bearing potential 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. * Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators). * Previous splenectomy * Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery. * Uncontrolled other inflammatory diseases * Current/recurrent infections that in the opinion of the PI risk\>benefit. * History of cancer within the past 5 years, except non-malignant skin cancer. * Chronic use of morphine or oxicodone
Where this trial is running
Amsterdam and 1 other locations
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology — Amsterdam, Netherlands (Recruiting)
- Greater Glasgow Health Board — Glasgow, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Operations Director
- Email: clinical@galvani.bio
- Phone: +44 (0)800 3688514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.