Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT03437473
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2018-03-06
2018-12-10
Brief Summary
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Detailed Description
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Subjects will be asked to visit the clinic at day 0, week 1-6, week 8 and week 12. During these visits, the following activities will be conducted: standard patient and physician assessments of RA activity, blood sample collection for RA biomarkers, and a hand MRI.
Subjects who complete the study will have the option to enroll in a long-term extension study. Subjects that do not participate in the extension study can opt to either have their device permanently inactivated and left in place or have the device surgically explanted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
QUADRUPLE
Study Groups
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Active stimulation QD
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Active stimulation QID
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
No stimulation
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Interventions
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SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have provided informed consent
3. Have a diagnosis of adult-onset rheumatoid arthritis as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
4. Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints and CDAI score \>10
5. Have been treated at approved doses with at least 2 biologic DMARDs and/or new targeted synthetic DMARDs (e.g. JAK inhibition) for at least 3 months and either:
1. experienced insufficient efficacy or loss of efficacy
2. experienced intolerance of such treatment
6. Have had regular use of at least 1 conventional DMARDs for at least the 12 weeks prior to study entry with a continuous, non-changing dose for at least 8 weeks prior to screening visit
7. Women of childbearing potential must not be pregnant at the time of screening and must agree to use a double barrier method of contraception throughout the study
Exclusion Criteria
i. Rituximab: 6 months ii. Infliximab, golimumab, adalimumab, certolizumab pegol, tocilizumab: 60 days iii. Abatacept, etanercept, anakinra: 30 days iv. Tofacitinib: 30 days v. Investigational biologic agents: 6 months for depleting agents, 60 days for others vi. Investigational small molecules: 5 times the pharmacokinetic half-life or 30 days, whichever is longer vii. Intra-articular corticosteroid injection: 30 days
2. Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening visit
3. Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of screening visit
4. Documented significant psychiatric illness or substance abuse
5. Active infection requiring treatment with antibiotics
6. Uncontrolled hypertension
7. Uncontrolled diabetes
8. History of stroke
9. Known cardiac disease, including cardiomyopathy with ejection fraction \<40%, recent myocardial infarction or unstable angina, or heart failure with New York Heart Association class III or IV symptoms
10. Known neurological syndromes
11. Known atherosclerotic disease including contralateral carotid artery
12. BMI \<18.5 or \>35
13. Any condition per the investigator's clinical judgment that precludes participation in the study
22 Years
75 Years
ALL
No
Sponsors
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SetPoint Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Genovese, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Northwell Health Division of Rheumatology
Great Neck, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Countries
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References
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Genovese MC, Gaylis NB, Sikes D, Kivitz A, Lewis Horowitz D, Peterfy C, Glass EV, Levine YA, Chernoff D. Safety and efficacy of neurostimulation with a miniaturised vagus nerve stimulation device in patients with multidrug-refractory rheumatoid arthritis: a two-stage multicentre, randomised pilot study. Lancet Rheumatol. 2020 Sep;2(9):e527-e538. doi: 10.1016/S2665-9913(20)30172-7. Epub 2020 Jul 28.
Other Identifiers
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SPM-008
Identifier Type: -
Identifier Source: org_study_id