RecruitingNot ApplicableNCT05003310

ConsideRAte Study - Splenic Stimulation for RA

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


Sponsor

Galvani Bioelectronics

Enrollment

28 participants

Start Date

Oct 19, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a device that stimulates the spleen (an organ involved in immune function) through a small implant, as a new way to treat rheumatoid arthritis (RA) — a condition where the immune system attacks the joints causing pain, swelling, and damage — in people who have not responded well to multiple medications. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis for at least 6 months - You are between 22 and 75 years old - Your RA is currently active and causing symptoms - You have tried at least 2 biologic medications and/or JAK inhibitors (including at least one TNF inhibitor) without adequate relief **You may NOT be eligible if...** - You have active or latent tuberculosis - You have HIV, active hepatitis B or C - You have had your vagus nerve cut (vagotomy) in the past - You have a serious psychiatric condition or active substance abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive Stimulation

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

DEVICESham Stimulation

Sham stimulation will be provided during the period

DRUGBaricitinib

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

DRUGBackground Treatment

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


Locations(14)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Medvin Research - Covina

Covina, California, United States

Medvin Research - Whittier

Whittier, California, United States

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, United States

NYU Langone

Brooklyn, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Altoona Center for Clinical Research

Altoona, Pennsylvania, United States

Arthritis & Rheumatology Institute

Allen, Texas, United States

St. David's Healthcare

Austin, Texas, United States

Tekton Research

Austin, Texas, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Southwest Rheumatology Research

Mesquite, Texas, United States

Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology

Amsterdam, Netherlands

Maxima Medical Center, MMC

Eindhoven, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05003310


Related Trials