Safety of Splenic Stimulation for RA

  • STATUS
    Recruiting
  • End date
    Jun 20, 2022
  • participants needed
    5
  • sponsor
    Galvani Bioelectronics
Updated on 20 August 2021
DMARD
antirheumatics

Summary

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.

Description

The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Details
Condition Rheumatoid Arthritis
Treatment Active stimulation
Clinical Study IdentifierNCT04955899
SponsorGalvani Bioelectronics
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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