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ConsideRAte Study - Splenic Stimulation for RA

NCT ID: NCT05003310
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Galvani Bioelectronics
Conditions: Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 28 participants (Estimated).

What is being studied

Device: Active Stimulation
Drug: Background Treatment
Intervention: baricitinib
Drug: Baricitinib
Device: Sham Stimulation

Who may be eligible

Ages: 22 Years to 75 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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

Study locations

14 study locations are listed.

Recruiting site status is explicitly provided for 14 locations; 12 are listed as Recruiting.

Countries: Netherlands, United States

Alabama, United States: 1
California, United States: 2
Maryland, United States: 1
New York, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 1
Texas, United States: 5

Sample of listed locations

Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology — Amsterdam, Netherlands — Recruiting
Maxima Medical Center, MMC — Eindhoven, Netherlands — Recruiting
Medvin Research - Covina — Covina, California, 91722, United States — Recruiting
Medvin Research - Whittier — Whittier, California, 90602, United States — Recruiting
The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland, 21740, United States — Recruiting
NYU Langone — Brooklyn, New York, 11201, United States — Recruiting
Oregon Health & Science University — Portland, Oregon, 97239, United States — Recruiting
Altoona Center for Clinical Research — Altoona, Pennsylvania, 16635, United States — Recruiting
Arthritis & Rheumatology Institute — Allen, Texas, 75013, United States — Recruiting
St. David's Healthcare — Austin, Texas, 78705, United States — Recruiting
Tekton Research — Austin, Texas, 78745, United States — Recruiting
Southwest Rheumatology Research — Mesquite, Texas, 75150, United States — Recruiting
Pinnacle Research Group, LLC — Anniston, Alabama, 36207, United States — Withdrawn
Metroplex Clinical Research Center — Dallas, Texas, 75231, United States — Withdrawn

Study details

Start date: October 19, 2021
Primary completion date: July 1, 2027
Completion date: April 1, 2032
First posted: August 12, 2021
Collaborators: NAMSA, Q2 Solutions

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05003310
Registry last updated: May 22, 2024
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT05003310 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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