Abdominal vagus nerve stimulation for moderate to severe drug-refractory rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label first-in-indication pilot will enroll five adults with moderate to severe, drug-refractory rheumatoid arthritis to test an implanted abdominal vagus nerve stimulation (aVNS) device. The device is placed by keyhole surgery and participants will self‑administer stimulation for about three hours per day using an external controller during the initial 2–24 week phase. Primary outcomes at 24 weeks are safety and device performance, with exploratory checks for signs of clinical benefit at 12 and 24 weeks; participants will be seen at 2, 6, 12, and 24 weeks and may continue using the device thereafter. All participants will be followed for safety twice a year for up to five years after implantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bionics Institute
  Fitzroy, Victoria, Australia Recruiting
• St Vincent's Hospital, Department of Rheumatology
  Fitzroy, Victoria, Australia Recruiting
• Austin Health, Heidelberg Repatriation Hospital
  Ivanhoe, Victoria, Australia Recruiting

Study contacts

• Principal investigator: A/Prof Shereen Oon — St Vincent's Hospital Melbourne
• Study coordinator: A/Prof Shereen Oon, MBBS, PhD
• Email: rheumclintrials@svha.org.au
• Phone: +61392311203

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Collarless Actis hip stem for cementless hip replacement in Asian patients

  This study tests how well a collarless Actis hip stem works in adults undergoing primary hip replacement, focusing on outcomes over five years in an East Asian population.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07828080

• BMS-986528 in people with hard-to-treat rheumatoid arthritis

  This study tests BMS-986528 to see if it is safe and tolerable and to gather early data on how it behaves in the body and whether it might slow rheumatoid arthritis.

  Recruiting at 10 sites Phase 1/2 Bristol-Myers Squibb · La Jolla, California and 38 other locations · NCT07412704

• Fucoidan for active rheumatoid arthritis

  This trial will test whether fucoidan, a seaweed-derived SR-A inhibitor, can reduce disease activity in adults (18–65) with active rheumatoid arthritis who have moderate-to-high disease activity despite current treatment.

  Recruiting Peking University People's Hospital · Beijing · NCT07045896

• Effects of phytocannabinoids on immune response in chronic inflammatory diseases

  This study is testing whether phytocannabinoids like CBD and THC can help improve the immune response in people with chronic inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.

  Recruiting Centre Hospitalier Régional d'Orléans · Orléans · NCT06842316

• Individualized tapering strategy for rheumatoid arthritis treatment

  This study is testing a personalized plan for reducing medication in people with rheumatoid arthritis who are in remission to see if it helps prevent flare-ups.

  Recruiting at 6 sites Phase 4 Centre Hospitalier Universitaire de Saint Etienne · Caluire-et-Cuire and 7 other locations · NCT06528431

• Effects of a high-fiber diet on gut health and rheumatoid arthritis symptoms

  This study is testing if a high-fiber diet can improve gut health and reduce symptoms for adults with rheumatoid arthritis.

  Recruiting Wuerzburg University Hospital · Würzburg · NCT06492200

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.