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Clinical Trials in the UK / NCT04955899
Recruiting Not applicable

Safety of Splenic Stimulation for RA

NCT04955899 · tracked via the Priya Life Science UK tracker
Sponsor
Galvani Bioelectronics
Phase
Not applicable
Started
2021-10-20
Last updated
2024-02-14

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Active Stimulation

Active Stimulation: The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Study summary

This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. 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). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Adult-onset RA of at least six months duration * Male or female participants, 22-75 years of age * Active RA * Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis) * Have an appropriate washout from previously used biological DMARDs or JAKi * A female participant should have no child-bearing potential 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. * Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators). * Previous splenectomy * Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery. * Uncontrolled other inflammatory diseases * Current/recurrent infections that in the opinion of the PI risk\>benefit. * History of cancer within the past 5 years, except non-malignant skin cancer. * Chronic use of morphine or oxicodone

Primary outcome measure(s)

  • Safety and tolerability of the Galvani system — 12 weeks
    Incidence and relatedness of Adverse Events (AEs), which 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 ECG

Trial sites (2)

FacilityCityRegionStatus
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology Amsterdam Netherlands Recruiting
Greater Glasgow Health Board Glasgow United Kingdom Recruiting

Other trials for the same condition

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Active, not recruiting
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis Recruiting
Comprehensive Nano - Post Market Clinical Follow-Up Study Active, not recruiting
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants Recruiting
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 NCT04955899 on ClinicalTrials.gov ↗ ← All trials in the UK