ConsideRAte Study - Splenic Stimulation for RA

NCT05003310 · tracked via the Priya Life Science USA tracker

Sponsor

Galvani Bioelectronics

Phase

Not applicable

Started

2021-10-19

Last updated

2024-05-22

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Active StimulationSham StimulationBaricitinibBackground Treatment

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)

Study 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

Sex

ALL

Min age

22 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Adverse Events [Safety and Tolerability] — Up through the end of Period 1 (Period 1 is up to 12 weeks duration)
Adverse Events (AEs) may include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead EKG
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — During Period 2 (Period 2 is up to 12 weeks in duration beyond Period 1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — During Period 3 (Period 3 is up to 24 weeks in duration beyond Period 2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — During Period 4 (Period 4 is up to 5 years in duration beyond Period 3)

Trial sites (14)

Facility	City	Region	Status
Pinnacle Research Group, LLC	Anniston	Alabama	Withdrawn
Medvin Research - Covina	Covina	California	Recruiting
Medvin Research - Whittier	Whittier	California	Recruiting
The Osteoporosis & Clinical Trials Center	Hagerstown	Maryland	Recruiting
NYU Langone	Brooklyn	New York	Recruiting
Oregon Health & Science University	Portland	Oregon	Recruiting
Altoona Center for Clinical Research	Altoona	Pennsylvania	Recruiting
Arthritis & Rheumatology Institute	Allen	Texas	Recruiting
St. David's Healthcare	Austin	Texas	Recruiting
Tekton Research	Austin	Texas	Recruiting
Metroplex Clinical Research Center	Dallas	Texas	Withdrawn
Southwest Rheumatology Research	Mesquite	Texas	Recruiting
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology	Amsterdam	Netherlands	Recruiting
Maxima Medical Center, MMC	Eindhoven	Netherlands	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05003310 on ClinicalTrials.gov ↗ ← All trials in the USA