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RECRUITING
NCT05003310
NA

ConsideRAte Study - Splenic Stimulation for RA

Sponsor: Galvani Bioelectronics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2021-10-19

Completion Date

2032-04

Last Updated

2024-05-22

Healthy Volunteers

No

Interventions

DEVICE

Active Stimulation

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

DEVICE

Sham Stimulation

Sham stimulation will be provided during the period

DRUG

Baricitinib

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

DRUG

Background 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