Safety of Splenic Stimulation for RA

Official title

A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device

Overview

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.

Detailed description

The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Interventions

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

Primary outcome measures

• Safety and tolerability of the Galvani system [Time frame: 12 weeks]

Secondary outcome measures (4)

• Effect of stimulation on the change in pharmacodynamic and response biomarkers [Time frame: Day 1 to week 12]
• To evaluate the usability of the external Galvani System devices and accessories [Time frame: 12 weeks]
• To evaluate the participants' perception of therapy and sensation [Time frame: 12 weeks]
• Evaluate device performance [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Netherlands · 1 center

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

United Kingdom · 1 center

• Greater Glasgow Health Board — Glasgow

Identifiers

NCT: NCT04955899 · GAL1039

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗