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Behavioural Intervention

Splenic Stimulation for Rheumatoid Arthritis

N/A
Recruiting
Research Sponsored by Galvani Bioelectronics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving treatment with standard dose(s) of conventional synthetic DMARD(s)
Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor.
Must not have
Active or latent tuberculosis
Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up through the end of period 1 (period 1 is up to 12 weeks duration)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial will evaluate the safety and effectiveness of a new implantable device to treat rheumatoid arthritis. The device is placed under the skin and sends electrical impulses to the nerves in the spleen.

Who is the study for?
This trial is for adults aged 22-75 with active rheumatoid arthritis (RA) who haven't responded well to at least two biologic DMARDs or JAK inhibitors, including a TNF inhibitor. They must have stopped previous RA treatments for a specific time before joining. People with implanted electrical devices, significant psychiatric issues, substance abuse problems, certain infections like COVID-19 or tuberculosis, HIV, hepatitis B/C, or those who've had vagotomy or splenectomy can't join.
What is being tested?
The study tests the Galvani System's safety and effects on stimulating the splenic neurovascular bundle in RA patients. It includes an initial randomized control phase where some get real stimulation and others sham (fake) treatment; followed by open label and treat-to-target periods; ending with long-term follow-up to assess outcomes.
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort at the implant site, infection risk from surgery or device presence in the body. There could also be unintended impacts on nearby organs due to nerve stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on standard doses of synthetic drugs for my autoimmune disease.
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I have not improved after trying at least two types of advanced arthritis medication.
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I have had rheumatoid arthritis for at least six months.
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I have active rheumatoid arthritis.
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I am between 22 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tuberculosis, whether active or not.
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I have HIV or current/past hepatitis B or C.
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I have had surgery to cut the nerves to my stomach.
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I have had my spleen removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up through the end of period 1 (period 1 is up to 12 weeks duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up through the end of period 1 (period 1 is up to 12 weeks duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Adverse Events [Safety and Tolerability]
Secondary study objectives
To evaluate the participants' perception of therapy and sensation
To evaluate the usability of the external Galvani System devices and accessories

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: RA drug combined with active stimulation, Period 3Experimental Treatment3 Interventions
Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks
Group II: Open label active stimulation, Period 2Experimental Treatment2 Interventions
Open label active stimulation for 12 additional weeks
Group III: Open label RA Drug, Period 2Experimental Treatment2 Interventions
Open label drug treatment with baricitinib for 12 weeks
Group IV: Long-term Follow-up, Period 4Experimental Treatment2 Interventions
Standard of care treatments with or without stimulation
Group V: Active stimulation combined with RA drug, Period 3Experimental Treatment3 Interventions
Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks
Group VI: Active Stimulation; Period 1Experimental Treatment2 Interventions
Active stimulation for 12 weeks
Group VII: Sham Stimulation; Period 1Placebo Group2 Interventions
Sham stimulation for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved

Find a Location

Who is running the clinical trial?

Galvani BioelectronicsLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
5 Patients Enrolled for Rheumatoid Arthritis
NAMSAOTHER
52 Previous Clinical Trials
20,665 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
5 Patients Enrolled for Rheumatoid Arthritis
Q2 SolutionsIndustry Sponsor
14 Previous Clinical Trials
1,637 Total Patients Enrolled

Media Library

Galvani System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05003310 — N/A
Rheumatoid Arthritis Research Study Groups: RA drug combined with active stimulation, Period 3, Long-term Follow-up, Period 4, Open label active stimulation, Period 2, Active stimulation combined with RA drug, Period 3, Open label RA Drug, Period 2, Active Stimulation; Period 1, Sham Stimulation; Period 1
Rheumatoid Arthritis Clinical Trial 2023: Galvani System Highlights & Side Effects. Trial Name: NCT05003310 — N/A
Galvani System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003310 — N/A
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05003310 — N/A
~13 spots leftby Jul 2027
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