A multipart exploratory study to evaluate splenic nerve stimulation in patients with rheumatoid arthritis.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Rheumatoid Arthritis
  • Age: Between 22 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Adult-onset RA of at least six months duration as defined by the 2010 ACR/EULAR classification criteria.
    2. Participants must have active disease as defined by at least 4 active swollen and at least 4 active tender joints and CRP greater than or equal to 5.0 mg/L
    3. The participant must have had an Inadequate Response to at least 2 biologic DMARDs and/or JAKinhibitors (JAKis) including at least one TNF inhibitor
    4. Participants must have an appropriate washout period as described below from previously used biological DMARDs or JAKi - all must be discontinued prior to Day 1:
      • At least 6 weeks prior to Day 1 (i.e.: 2 weeks prior to surgery):Tofacitinib and upadacitinib; as well as anakinra, etanercept, infliximab and tocilizumab
      • At least 8 weeks prior to Day 1: Adalimumab, certolizumab pegol, golimumab and abatacept
      • At least 6 months prior to Day 1:Belimumab, rituximab, or other selective B lymphocyte depleting agents
    5. Participants must be receiving treatment with standard dose(s) of conventional synthetic DMARD(s) including methotrexate (MTX), leflunomide, hydroxychloroquine or sulfasalazine, or a combination thereof and this conventional synthetic DMARD regimen must have been stable with tolerated doses and no change in doses or routes of administration for a minimum of 12 weeks before randomization and be kept stable thereafter.
    6. Demonstrate, or simulate, ability to use the Galvani System components
    7. For Female Participants Only: A female participant is eligible to participate if she is not pregnant or breastfeeding or planning on becoming pregnant in the future, and is a woman of non-childbearing potential OR using acceptable contraceptive methods

You may not be eligible for this study if the following are true:

    1. Prior use of baricitinib or for whom baricitinib use is not recommended
    2. Inability to provide informed consent
    3. Significant psychiatric disease or substance abuse
    4. History of unilateral or bilateral vagotomy
    5. Active or latent tuberculosis
    6. Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
    7. Positive SARS COV 2 PCR screening test for COVID-19 infection
    8. Currently implanted electrically active medical devices
    9. Any prior investigational treatment must be discontinued for at least 4 weeks or 5 half-lives, whichever is longer, prior to Day 1
    10. Patients with comorbid fibromyalgia
    11. Previous splenectomy
    12. Drug or alcohol abuse or dependence including opioid dependence or chronic opioid use
    13. Laboratory exclusion criteria: cytopenia as characterized by – anemia, lymphopenia and/or neutropenia
    14. Any finding – which in the opinion of the investigator would interfere with the study interventions (including device implantation), study procedures and/or assessments, or create an undue risk for the participant



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