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Tests treatment safety and results for Arthritis, Rheumatoid
Official title The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07017686
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female (18 - 75 years of age).
- Adult-onset rheumatoid arthritis (RA) (onset age 18 years or above) as defined by the 2010 ACR/EULAR classification criteria, and Rheumatoid Factor...
- Moderate-severe active RA defined by at least 4/28 tender and 4/28 swollen joints.
- 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...
- 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...
You likely can't join if
- Unable or unwilling to provide written informed consent.
- Current diagnosis of major psychiatric disorder/s, or meets criteria as such on the Mini International Neuropsychiatric Interview (MINI), with the...
- A medical condition that could interfere with study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator.
- Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease.
- History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery.
- History of gastric hiatus hernia.
See the full eligibility criteria
- Male or female (18 - 75 years of age).
- 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...
- Moderate-severe active RA defined by at least 4/28 tender and 4/28 swollen joints.
- 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).
- 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.
- 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.
- Medicare eligibility.
- Provision of informed consent, in the form of a signed and dated informed consent form.
- Unable or unwilling to provide written informed consent.
- 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...
- A medical condition that could interfere with study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator.
- Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease.
- History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery.
- History of gastric hiatus hernia.
- 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...
- A condition that requires routine Magnetic Resonance Imaging (MRI) scans
- Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Fitzroy, Victoria, Australia
- Ivanhoe, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fitzroy, Victoria, Australia; Ivanhoe, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.