Splenic Stimulation for RA

  • STATUS
    Recruiting
  • End date
    Jan 31, 2029
  • participants needed
    28
  • sponsor
    Galvani Bioelectronics
Updated on 31 October 2021
tumor necrosis factor
DMARD
baricitinib

Summary

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.

Description

Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1).

Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks.

At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks.

Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.

Details
Condition Rheumatoid Arthritis
Treatment sham stimulation, Baricitinib, Active stimulation, Background Treatment
Clinical Study IdentifierNCT05003310
SponsorGalvani Bioelectronics
Last Modified on31 October 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) including at least one TNF inhibitor
Have an appropriate washout from previously used biological DMARDs or JAKi
Receiving treatment with standard dose(s) of conventional synthetic DMARD(s)

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
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)
Previous splenectomy
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