ConsideRAte Study - Splenic Stimulation for RA

NCT05003310 | Recruiting DMC FDA Device

• 1 other identifier: GAL1040
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Electrical stimulation; random allocation; inflammation; active implantable medical device; Laparoscopy; antirheumatic agents; autonomic nervous system; feasibility studies

Outcome Measures

Primary Outcomes (4)

• Incidence of Adverse Events [Safety and Tolerability]

  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

  Up through the end of Period 1 (Period 1 is up to 12 weeks duration)

• 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)

Secondary Outcomes (36)

• Change in the 28 Joint Disease Activity Score 28 - C reactive protein (DAS28-CRP)

  Baseline to 12 weeks (Period 1)

• Change in the level of Lipopolysaccharide (LPS)-inducible release of Tumor Necrosis Factor (TNFα) in whole blood assay

  Baseline to 12 weeks (Period 1)

• Change in the level of LPS-inducible release of TNFα in whole blood assay

  Baseline to 24 weeks (Period 2)

• Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay

  Baseline to 12 weeks (Period 1)

• Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay

  Baseline to 24 weeks (Period 2)

Study Arms (7)

Active Stimulation; Period 1

EXPERIMENTAL

Active stimulation for 12 weeks

Device: Active Stimulation; Drug: Background Treatment

Sham Stimulation; Period 1

SHAM COMPARATOR

Sham stimulation for 12 weeks

Device: Sham Stimulation; Drug: Background Treatment

Open label active stimulation, Period 2

EXPERIMENTAL

Open label active stimulation for 12 additional weeks

Device: Active Stimulation; Drug: Background Treatment

Open label RA Drug, Period 2

OTHER

Open label drug treatment with baricitinib for 12 weeks

Drug: Baricitinib; Drug: Background Treatment

RA drug combined with active stimulation, Period 3

EXPERIMENTAL

Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks

Device: Active Stimulation; Drug: Baricitinib; Drug: Background Treatment

Active stimulation combined with RA drug, Period 3

EXPERIMENTAL

Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks

Device: Active Stimulation; Drug: Baricitinib; Drug: Background Treatment

Long-term Follow-up, Period 4

OTHER

Standard of care treatments with or without stimulation

Device: Active Stimulation; Drug: Background Treatment

Interventions

Active Stimulation DEVICE

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

Active Stimulation; Period 1; Active stimulation combined with RA drug, Period 3; Long-term Follow-up, Period 4; Open label active stimulation, Period 2; RA drug combined with active stimulation, Period 3

Sham Stimulation DEVICE

Sham stimulation will be provided during the period

Sham Stimulation; Period 1

Baricitinib DRUG

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

Active stimulation combined with RA drug, Period 3; Open label RA Drug, Period 2; RA drug combined with active stimulation, Period 3

Background Treatment DRUG

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

Active Stimulation; Period 1; Active stimulation combined with RA drug, Period 3; Long-term Follow-up, Period 4; Open label RA Drug, Period 2; Open label active stimulation, Period 2; RA drug combined with active stimulation, Period 3; Sham Stimulation; Period 1

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galvani Bioelectronics: lead
• NAMSA: collaborator
• Q2 Solutions: collaborator

Study Sites (14)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

WITHDRAWN

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

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

WITHDRAWN

Southwest Rheumatology Research

Mesquite, Texas, 75150, United States

RECRUITING

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

Amsterdam, Netherlands

RECRUITING

Maxima Medical Center, MMC

Eindhoven, Netherlands

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Operations Director

CONTACT

+1 877 613 9001; clinical@galvani.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter study with 4 periods. Period 1 is a randomized, controlled double-blind period where participants are assigned randomly to either active or sham stimulation. During the open-label Periods 2 through 4, participants are assigned treatment based on responses to treatments in the prior period

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 12, 2021
• Study Start: October 19, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): April 1, 2032
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

US (12); NL (2)