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Device

Vagus Nerve Stimulation for Rheumatoid Arthritis (RESET-RA Trial)

Phase 3
Recruiting
Led By Jeffrey R Curtis, MD MPH
Research Sponsored by SetPoint Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
22-75 years of age at screening
Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
Timeline
Screening 28 days
Treatment 24 months
Follow Up 2 months
Awards & highlights

RESET-RA Trial Summary

This trial will assess the safety and efficacy of a new device designed to treat rheumatoid arthritis by stimulating the vagus nerve. The study will enroll 250 subjects at 40 sites, who will either receive active or non-active stimulation. There will be a one-way crossover of control subjects to active stimulation after 12 weeks, and all subjects will receive active stimulation for the next 180 weeks to evaluate long-term safety.

Who is the study for?
Adults aged 22-75 with active, moderate to severe rheumatoid arthritis who haven't responded well or can't tolerate certain advanced RA medications. Participants must be on a stable dose of conventional synthetic DMARD for at least 12 weeks before the trial and continue it through Week 12. People with recurrent fainting episodes, significant psychiatric or substance abuse history, stroke/TIA, serious heart disease, neurological disorders like MS/Alzheimer's/Parkinson's, uncontrolled fibromyalgia, past carotid surgery/splenectomy/vagotomy or tobacco users are excluded.Check my eligibility
What is being tested?
The RESET-RA study is testing the SetPoint System device that stimulates the vagus nerve to treat rheumatoid arthritis. The device is implanted via surgery under general anesthesia. Of the enrolled participants, half will receive actual stimulation while the other half will get non-active stimulation as a control group initially; after Week 12 all subjects will receive active stimulation for long-term safety assessment.See study design
What are the potential side effects?
Potential side effects may include complications from neck surgery such as infection or pain at implant site; adverse reactions to anesthesia; possible changes in voice tone due to vagus nerve proximity; discomfort from electrical stimulation; and typical risks associated with any surgical procedure.

RESET-RA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 75 years old.
Select...
I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.
Select...
I am between 22 and 75 years old.
Select...
I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.
Select...
I have rheumatoid arthritis and treatments like biologics or JAK inhibitors haven’t worked for me.

RESET-RA Trial Timeline

Screening ~ 28 days
Treatment ~ 24 months
Follow Up ~2 months
This trial's timeline: 28 days for screening, 24 months for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the American College of Rheumatology (ACR) 20 response
Secondary outcome measures
ACR20 response at Week 12 from Day 0
DAS28-CRP response (MCID -1.2) at Week 12
Diabetes Insipidus
+1 more

Side effects data

From 2019 Phase 4 trial • 149 Patients • NCT01548768
1%
Worsening Migraine
1%
Mobitz II Heart Block
1%
Angina
1%
Atrial Tachycardia
1%
Panic Attack
1%
Thrombophlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients - Cross Sectional (RA)
RA Patients - Pharmacotherapy Escalation (TNFi)
RA Patients - Pharmacotherapy Escalation (DMARD)
Healthy Volunteers

RESET-RA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment3 Interventions
Active stimulation for 1 min once per day
Group II: ControlPlacebo Group3 Interventions
Non-active stimulation for 1 min once per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active stimulation
2022
Completed Phase 3
~340

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

SetPoint Medical CorporationLead Sponsor
6 Previous Clinical Trials
94 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
64 Patients Enrolled for Rheumatoid Arthritis
Jeffrey R Curtis, MD MPHPrincipal InvestigatorUniversity of Alabama, Birmingham, AL
John Tesser, MDPrincipal InvestigatorArizona Arthritis and Rheumatology Research, P.C.

Media Library

SetPoint System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04539964 — Phase 3
Rheumatoid Arthritis Research Study Groups: Treatment, Control
Rheumatoid Arthritis Clinical Trial 2023: SetPoint System Highlights & Side Effects. Trial Name: NCT04539964 — Phase 3
SetPoint System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04539964 — Phase 3
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04539964 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA endorse this surgical method?

"The safety of the Implant Procedure has been evaluated as a 3 by our team at Power. This is due to the fact that it is a Phase 3 trial, which suggests that not only is there some evidence for its efficacy, but also that multiple rounds of data support its safety."

Answered by AI

If a patient is over 25, do they still qualify for the trial?

"The age requirement for this trial is between 22 and 75 years old. There are 52 clinical trials that cater to people under 18 and 345 for those over 65."

Answered by AI

Are there any specific requirements for volunteers for this research project?

"We are looking for around 250 individuals aged 22-75 that have a diagnosis of rheumatoid arthritis. In addition, these patients must currently be experiencing active moderate or severe RA symptoms, as indicated by 4 or more swollen joints and 4 or more tender joints."

Answered by AI

Do you still need participants for this experiment?

"That is correct. As of November 2nd, 2022, this study is still looking for 250 individuals to take part in the clinical trial which is being conducted at 23 hospitals."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Arizona Arthritis Rheumatology & Research, PLLC
Arizona Arthritis ans Rheumatology Research, PPLC
University of Pennsylvania Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

Have tried Synvisc one....it has been of little benefit. I've tried numerous medications over the past 40 years.
PatientReceived 2+ prior treatments
I have exhausted all RA meds and do not wish to use biologicals. I'm experiencing alot of pain,numbing,no medication seems to help.
PatientReceived no prior treatments
I’ve just been diagnosed with potential RA by blood test. My fingers and toes have arthritis and possibly my knee.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Do you have clinical studies with regard to the vagus pump closer to San Francisco?
PatientReceived no prior treatments
How long is the trial period? Will I be required to change my medication during the trial?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Arthritis & Rheumatology Research Institute, PLLC: < 24 hours
  2. Arthritis & Rheumatology Institute: < 48 hours
  3. Central Texas Rheumatology Associates: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
2021. "Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04539964.
All > Rheumatoid Arthritis > Ra
~59 spots leftby Apr 2025
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