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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
Must not have
Significant immunodeficiency due to underlying illness
History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
Timeline
Screening 28 days
Treatment 24 months
Follow Up 2 months
Awards & highlights
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 75 years old.
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I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.
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I am between 22 and 75 years old.
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I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.
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I have rheumatoid arthritis and treatments like biologics or JAK inhibitors haven’t worked for me.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that significantly weakens my immune system.
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I have had a stroke, TIA, or have cerebrovascular fibromuscular dysplasia.
Select...
I have a serious heart condition.
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I have a neurological condition like MS, Alzheimer's, or Parkinson's.
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My fibromyalgia is not under control.
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I have had surgery on my carotid artery.
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I have had surgery on my stomach nerves or spleen.
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I frequently faint due to sudden drops in my heart rate and blood pressure.
Timeline
Screening ~ 28 days2 visits
Treatment ~ 24 months14 visits
Follow Up ~ 2 months12 visits
Screening ~ 28 days
Treatment ~ 24 months
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
the American College of Rheumatology (ACR) 20 response
Secondary study objectives
ACR20 response at Week 12 from Day 0
DAS28-CRP response (MCID -1.2) at Week 12
Diabetes Insipidus
+1 moreSide effects data
From 2019 Phase 4 trial • 149 Patients • NCT015487681%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have rheumatoid arthritis and treatments like biologics or JAK inhibitors haven’t worked for me.I have a condition that significantly weakens my immune system.I frequently faint due to sudden drops in my heart rate and blood pressure.I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.I have been on a stable dose of a DMARD for my condition for at least 12 weeks.I have had surgery on my carotid artery.I am between 22 and 75 years old.I am between 22 and 75 years old.I have active rheumatoid arthritis with at least 4 tender and 4 swollen joints.You currently smoke or use tobacco products regularly.You are allergic to the contrast agents used in MRI scans or you cannot undergo an MRI.You have a mental illness that is not being treated or controlled well, or a history of substance abuse.I have had a stroke, TIA, or have cerebrovascular fibromuscular dysplasia.I have a serious heart condition.I have a neurological condition like MS, Alzheimer's, or Parkinson's.My fibromyalgia is not under control.I have had surgery on my stomach nerves or spleen.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 24 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Months after you stop receiving the treatment.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04539964 — Phase 3
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