Rheumatoid ArthritisNCT04955899
Safety of Splenic Stimulation for RA
A study testing Active Stimulation in people with Rheumatoid Arthritis, run by Galvani Bioelectronics at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Active Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2021to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam
Study Coordinator
Sander Tas, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Greater Glasgow Health Board
Glasgow, G12 OXH
Operations Director, +44 (0)800 3688514, clinical@galvani.bio
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Active Stimulation
- Keywords
- Electrical stimulation, inflammation, active implantable medical device, Laparoscopy, antirheumatic agents, autonomic nervous system, feasibility studies
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StimulationDevice
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Active stimulation for 12 weeks Receives: Device: Active Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
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
Measured: Day 1 to week 12
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
Measured: 12 weeks
To evaluate the participants' perception of therapy and sensation
Summarize feedback collected on questionnaires
Measured: 12 weeks
Evaluate device performance
Tabulation of device deficiencies
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start20 Oct 2021
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galvani Bioelectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955899
- Sponsor's protocol ID
- GAL1039
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04955899
- Acronym / sponsor ID
- GAL1039
- Conditions
- Rheumatoid Arthritis
- Keywords
- Electrical stimulation, inflammation, active implantable medical device, Laparoscopy, antirheumatic agents, autonomic nervous system, feasibility studies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Galvani BioelectronicsIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active StimulationActive stimulation for 12 weeks |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active StimulationThe Galvani System will be implanted in eligible participants, and stimulation will be turned ON | Device | Active Stimulation |
Primary outcome
Safety and tolerability of the Galvani system
Time frame: 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Stimulation in people with Rheumatoid Arthritis, run by Galvani Bioelectronics at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Operations Director (+44 (0)800 3688514, clinical@galvani.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the Galvani system (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.