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Safety of Splenic Stimulation for RA

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active Stimulation
Sponsored by
Galvani Bioelectronics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Rheumatoid Arthritis focused on measuring Electrical stimulation, inflammation, active implantable medical device, Laparoscopy, antirheumatic agents, autonomic nervous system, feasibility studies

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Greater Glasgow Health BoardRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Stimulation

Arm Description

Active stimulation for 12 weeks

Outcomes

Primary Outcome Measures

Safety and tolerability of the Galvani system
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

Secondary Outcome Measures

Effect of stimulation on the change in pharmacodynamic and response biomarkers
Changes from baseline (Day 1) in the levels of LPS-inducible cytokine/ chemokine release, in whole blood assay at different timepoints after start of stimulation
To evaluate the usability of the external Galvani System devices and accessories
Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices
To evaluate the participants' perception of therapy and sensation
Summarize feedback collected on questionnaires
Evaluate device performance
Tabulation of device deficiencies

Full Information

First Posted
July 5, 2021
Last Updated
October 25, 2021
Sponsor
Galvani Bioelectronics
Collaborators
NAMSA
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1. Study Identification

Unique Protocol Identification Number
NCT04955899
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galvani Bioelectronics
Collaborators
NAMSA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Electrical stimulation, inflammation, active implantable medical device, Laparoscopy, antirheumatic agents, autonomic nervous system, feasibility studies

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Stimulation
Arm Type
Experimental
Arm Description
Active stimulation for 12 weeks
Intervention Type
Device
Intervention Name(s)
Active Stimulation
Intervention Description
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
Primary Outcome Measure Information:
Title
Safety and tolerability of the Galvani system
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect of stimulation on the change in pharmacodynamic and response biomarkers
Description
Changes from baseline (Day 1) in the levels of LPS-inducible cytokine/ chemokine release, in whole blood assay at different timepoints after start of stimulation
Time Frame
Day 1 to week 12
Title
To evaluate the usability of the external Galvani System devices and accessories
Description
Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices
Time Frame
12 weeks
Title
To evaluate the participants' perception of therapy and sensation
Description
Summarize feedback collected on questionnaires
Time Frame
12 weeks
Title
Evaluate device performance
Description
Tabulation of device deficiencies
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Operations Director
Phone
+44 (0)800 3688514
Email
clinical@galvani.bio
Facility Information:
Facility Name
Greater Glasgow Health Board
City
Glasgow
ZIP/Postal Code
G12 OXH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Operations Director
Phone
+44 (0)800 3688514
Email
clinical@galvani.bio

12. IPD Sharing Statement

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Safety of Splenic Stimulation for RA

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