Rheumatoid Arthritis Trial, Recruiting NCT07017686 Sponsor: The Bionics Institute of Australia Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT07017686
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old (male or female)
  • You have been diagnosed with rheumatoid arthritis (RA) that started when you were 18 or older, and a specific blood test for RA (RF, CCP, or ACPA) has come back positive
  • Your RA is moderately to severely active, with at least 4 tender and 4 swollen joints (out of 28 checked)
  • Your RA has not improved enough after trying at least 2 biologic or targeted treatments (such as JAK inhibitors) for 3 months, or you were unable to tolerate them
  • You have been on a stable, unchanged dose of at least one RA medication for more than 8 weeks before the study starts, and you are willing to stay on it throughout the trial
  • If you are a woman who could become pregnant, you must not currently be pregnant or trying to become pregnant, and you agree to use reliable contraception throughout the trial
  • You are eligible for Medicare
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You are unwilling or unable to sign a written consent form
  • You have a major psychiatric condition that is not well-controlled (note: stable, well-managed depression or anxiety may still be acceptable — confirm with trial site)
  • You have a medical condition that could interfere with the study or make results harder to interpret, as decided by the study doctor
  • You have severe nerve damage affecting automatic body functions (such as poorly controlled type 2 diabetes) (confirm with trial site)
  • You have previously had certain surgeries, including removal of the vagus nerve (vagotomy), removal of the spleen, or weight-loss (bariatric) surgery
  • You have a history of a hiatus hernia (where part of the stomach pushes up into the chest)
  • You already have an implanted medical device (such as a pacemaker, spinal cord stimulator, or drug pump), or you are likely to need one within 6 months of starting the study
  • You regularly need MRI scans for any ongoing medical condition
  • The study doctor does not consider you a suitable candidate for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: A/Prof Shereen Oon, St Vincent's Hospital Melbourne

Phone: +61392311203

Australian sites

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

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The Bionics Institute of Australia
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 September 2027

Where this trial is recruiting

🇦🇺 Australia

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.; Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.; Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov