No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
5 (estimated)
Sponsor
The Bionics Institute of Australia · Other
Who this trial is looking for
This trial is looking for adults with moderate to severe rheumatoid arthritis that has not responded to medication. Participants will receive a device that stimulates the abdominal vagus nerve and will be monitored for safety and outcomes for five years after surgery.
Are You a Good Fit for This Trial?
Must be takingBiologic DMARDSynthetic DMARD
Rules you outMajor psychiatric disorder
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with adult-onset rheumatoid arthritis.
I have moderate to severe active rheumatoid arthritis.
My rheumatoid arthritis has not responded to at least two medication trials.
I have been on a stable dose of medication for over 8 weeks.
I am not pregnant and will use contraception if I am of childbearing age.
I am eligible for Medicare.
I can provide informed consent.
You may not be able to join if
I am unable or unwilling to provide written informed consent.
I currently have a major psychiatric disorder.
I have a medical condition that could interfere with this study.
I have severe autonomic neuropathy.
I have had certain surgeries that may affect the study.
I have a history of gastric hiatus hernia.
I have previously implanted active medical devices.
I am considered unsuitable for this trial by the doctors.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This open label clinical trial aims to assess the safety of abdominal vagus nerve stimulation (aVNS) for moderate to severe, adult-onset rheumatoid arthritis (RA) that has not responded to medication. The aVNS is an active medical device placed into the body to allow electrical stimulation of the abdominal vagus nerve. Participants will undergo stimulation treatment with the aVNS device from two t…
This open label clinical trial aims to assess the safety of abdominal vagus nerve stimulation (aVNS) for moderate to severe, adult-onset rheumatoid arthritis (RA) that has not responded to medication. The aVNS is an active medical device placed into the body to allow electrical stimulation of the abdominal vagus nerve. Participants will undergo stimulation treatment with the aVNS device from two to 24 weeks after the device is implanted by keyhole surgery. Safety, device performance and potential benefits will be assessed. Participants will be monitored for specific events for 5 years post surgery.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Male or female (18 - 75 years of age).
2. Adult-onset rheumatoid arthritis (RA) (onset age 18 years or above) as defined by the 2010 ACR/EULAR classification criteria, and Rheumatoid Factor (RF) or Cyclic Citrullinated Peptide (CCP) Antibody/Anti-Citrullinated Peptide Antibod…
Inclusion Criteria:
1. Male or female (18 - 75 years of age).
2. Adult-onset rheumatoid arthritis (RA) (onset age 18 years or above) as defined by the 2010 ACR/EULAR classification criteria, and Rheumatoid Factor (RF) or Cyclic Citrullinated Peptide (CCP) Antibody/Anti-Citrullinated Peptide Antibody (ACPA) must be positive (above lab ranges).
3. Moderate-severe active RA defined by at least 4/28 tender and 4/28 swollen joints.
4. Have active disease that has not responded to a 3-month trial of, or has intolerance limiting a full 3 month trial of, at least 2 biologic and/or new targeted synthetic DMARDs (e.g. JAK inhibitors).
5. Using a stable, continuous dose of at least 1 biological and/or synthetic DMARD for \>8 weeks prior to study screening and for the duration of the trial.
6. Women of childbearing age must not be pregnant or trying to become pregnant and must agree to use an effective method of contraception for the duration of their participation in the trial.
7. Medicare eligibility.
8. Provision of informed consent, in the form of a signed and dated informed consent form.
Exclusion Criteria:
1. Unable or unwilling to provide written informed consent.
2. Current diagnosis of major psychiatric disorder/s, or meets criteria as such on the Mini International Neuropsychiatric Interview (MINI), with the exception of stable, well controlled Major Depression or Anxiety Disorder.
3. A medical condition that could interfere with study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator.
4. Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease.
5. History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery.
6. History of gastric hiatus hernia.
7. Previously implanted active medical devices (e.g., dorsal root ganglion or spinal cord stimulators, cardiac pacemakers, automatic implantable cardioverter-defibrillators, drug pumps), or likely need for implantation of such devices within 6 months after start of this study.
8. A condition that requires routine Magnetic Resonance Imaging (MRI) scans
9. Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.
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