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ConsideRAte Study - Splenic Stimulation for RA

Galvani Bioelectronics · with NAMSA, Q2 Solutions · NCT05003310

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
28
US sites recruiting
10
Study start
October 19, 2021
Record last updated
May 22, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Active Stimulation; Sham Stimulation; Baricitinib; Background Treatment

Conditions: Rheumatoid Arthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Medvin Research - Covina

    Covina, CA 91722

    Site contact: Study Coordinator · 626-869-5730 · Info@medvinresearch.com

  • Medvin Research - Whittier

    Whittier, CA 90602

    Site contact: Study Coordinator · 562-758-6600 · Info@medvinresearch.com

  • The Osteoporosis & Clinical Trials Center

    Hagerstown, MD 21740

    Site contact: Study Coordinator · 301-791-6680 · arthritis@rheumdocs.com

  • NYU Langone

    Brooklyn, NY 11201

    Site contact: Galvani Operations Director · 877-613-9001 · clinical@galvani.bio

  • Oregon Health & Science University

    Portland, OR 97239

    Site contact: Cong-Qui Chu, MD · 503-494-8637

  • Altoona Center for Clinical Research

    Altoona, PA 16635

    Site contact: Study Coordinator · 800-924-7790

  • Arthritis & Rheumatology Institute

    Allen, TX 75013

    Site contact: Study Coordinator · 972-798-8553

  • St. David's Healthcare

    Austin, TX 78705

    Site contact: SDH Office of Research; Research Dept · 512-544-8070 · Krishna.Saini@stdavids.com

  • Tekton Research

    Austin, TX 78745

    Site contact: Study Coordinator · 512-388-5717 · trials@tektonresearch.com

  • Southwest Rheumatology Research

    Mesquite, TX 75150

    Site contact: Study Coordiinator · 972-288-2600 · jointpain@swrr.net

Study contacts (from the official record)

  • Operations Director · +1 877 613 9001 · clinical@galvani.bio
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ConsideRAte Study - Splenic Stimulation for RA (NCT05003310) | Bored Studies