ConsideRAte Study - Splenic Stimulation for RA

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.

Eligibility

Inclusion Criteria:

* RA of at least six months duration, per 2010 ACR/EULAR criteria
* 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 current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance

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

Conditions2

Interventions2

Locations12 sites

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