ConsideRAte Study - Splenic Stimulation for RA

Description

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.

Conditions

Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

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.

Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis

ConsideRAte Study - Splenic Stimulation for RA

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Anniston

Pinnacle Research Group, LLC, Anniston, Alabama, United States, 36207

Covina

Medvin Research - Covina, Covina, California, United States, 91722

Whittier

Medvin Research - Whittier, Whittier, California, United States, 90602

Hagerstown

The Osteoporosis & Clinical Trials Center, Hagerstown, Maryland, United States, 21740

Brooklyn

NYU Langone, Brooklyn, New York, United States, 11201

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Altoona

Altoona Center for Clinical Research, Altoona, Pennsylvania, United States, 16635

Allen

Arthritis & Rheumatology Institute, Allen, Texas, United States, 75013

Austin

St. David's Healthcare, Austin, Texas, United States, 78705

Austin

Tekton Research, Austin, Texas, United States, 78745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Galvani Bioelectronics,

Study Record Dates

2032-04