Safety of Splenic Stimulation for RA
Recruiting · NCT04955899 · Interventional (participants receive a specific treatment) · Lead sponsor: Galvani Bioelectronics
View the official record on ClinicalTrials.gov →Interventions studied
Active Stimulation
What this trial is about
This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. 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). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.
Who can take part
Age range
22 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology - Amsterdam, Netherlands
- Greater Glasgow Health Board - Glasgow, United Kingdom