Recruiting

Splenic Stimulation

Sponsor:

Galvani Bioelectronics

Code:

NCT05003310

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Stimulation

Sham Stimulation

Baricitinib

Background Treatment

Study Details

Brief 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.

Conditions

Rheumatoid Arthritis

Study ID

NCT05003310

Start date

Oct 19, 2021

Status verified date

May, 2024

Completion date

Apr, 2032

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Stimulation; Period 1

Active stimulation for 12 weeks

sham comparator: Sham Stimulation; Period 1

Sham stimulation for 12 weeks

experimental: Open label active stimulation, Period 2

Open label active stimulation for 12 additional weeks

other: Open label RA Drug, Period 2

Open label drug treatment with baricitinib for 12 weeks

experimental: RA drug combined with active stimulation, Period 3

Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks

experimental: Active stimulation combined with RA drug, Period 3

Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks

other: Long-term Follow-up, Period 4

Standard of care treatments with or without stimulation

Interventions

Active Stimulation

Stimulation will be turned ON and applied during each day of the period.

Sham Stimulation

Sham stimulation will be provided during the period

Baricitinib

Baricitinib (2 mg) is administered daily during the period.

Background Treatment

Stable dose of standard background treatment (e.g., csDMARD therapy)

Primary outcome measure

  • Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: Up through the end of Period 1 (Period 1 is up to 12 weeks duration) ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: During Period 2 (Period 2 is up to 12 weeks in duration beyond Period 1) ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: During Period 3 (Period 3 is up to 24 weeks in duration beyond Period 2) ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: During Period 4 (Period 4 is up to 5 years in duration beyond Period 3) ]

Central Contacts and Locations

Central contacts

Operations Director

+1 877 613 9001clinical@galvani.bio

Locations

Medvin Research - Covina

Recruiting

Covina, California, United States, 91722

Contacts

Study Coordinator

626-869-5730Info@medvinresearch.com

Principal Investigator:

Samy Metyas, MD

Medvin Research - Whittier

Recruiting

Whittier, California, United States, 90602

Contacts

Study Coordinator

562-758-6600Info@medvinresearch.com

Principal Investigator:

Tien-I Karleen Su, MD

The Osteoporosis & Clinical Trials Center

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Study Coordinator

301-791-6680arthritis@rheumdocs.com

Principal Investigator:

Mary Howell, MD

NYU Langone

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Galvani Operations Director

877-613-9001clinical@galvani.bio

Principal Investigator:

David Goddard, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Cong-Qui Chu, MD

503-494-8637

Altoona Center for Clinical Research

Recruiting

Altoona, Pennsylvania, United States, 16635

Contacts

Study Coordinator

800-924-7790

Principal Investigator:

Alan Kivitz, MD

Arthritis & Rheumatology Institute

Recruiting

Allen, Texas, United States, 75013

Contacts

Study Coordinator

972-798-8553

Principal Investigator:

Megha Patel-Banker, MD

St. David's Healthcare

Recruiting

Austin, Texas, United States, 78705

Contacts

SDH Office of Research; Research Dept

512-544-8070Krishna.Saini@stdavids.com

Principal Investigator:

Robert J. Koval, MD

Tekton Research

Recruiting

Austin, Texas, United States, 78745

Contacts

Study Coordinator

512-388-5717trials@tektonresearch.com

Principal Investigator:

Paul Pickrell, MD

Southwest Rheumatology Research

Recruiting

Mesquite, Texas, United States, 75150

Contacts

Study Coordiinator

972-288-2600jointpain@swrr.net

Principal Investigator:

Atul Singhal, MD

More Information

Sponsor

Galvani Bioelectronics

Last update posted

May 22, 2024

Last verified

May, 2024

Keywords

  • Electrical stimulation
  • random allocation
  • inflammation
  • active implantable medical device
  • Laparoscopy
  • antirheumatic agents
  • autonomic nervous system
  • feasibility studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Galvani Bioelectronics on 2024-05-22.