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Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT03437473
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
SetPoint Medical Corporation

Brief Summary:
Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System Not Applicable

Detailed Description:

This is a two-stage study where Stage 1 is open label, and Stage 2 is randomized and sham controlled where the sites and subjects are blinded to treatment. Three subjects will be enrolled in Stage 1 of the study. And 12 subjects will be enrolled in Stage 2. Subjects will be treated for a total of 12 weeks.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: A Randomized Controlled Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active stimulation QD Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Other Name: SetPoint System

Active Comparator: Active stimulation QID Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Other Name: SetPoint System

Sham Comparator: No stimulation Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Other Name: SetPoint System




Primary Outcome Measures :
  1. incidence of Adverse Events [ Time Frame: Enrollment to Week 12 ]
    treatment-emergent incidence rates of Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device Effects, and Unanticipated Serious Adverse Device Effects


Secondary Outcome Measures :
  1. change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP) [ Time Frame: change from baseline at Day 0 and Week 12 ]
    comparison between the active device group and the inactive device group of the change in DAS28-CRP

  2. change in American College of Rheumatology (ACR) 20, 50 and 70 response rates [ Time Frame: change from baseline at Day 0 and Week 12 ]
    comparison between the active device group and the inactive device group of the change in ACR 20/50/70

  3. change in European League Against Rheumatism (EULAR) response and remission rate [ Time Frame: change from baseline at Day 0 and Week 12 ]
    comparison between the active device group and the inactive device group of the change in EULAR

  4. change in hand MRI [ Time Frame: change from baseline at Day 0 and Week 12 ]
    comparison between the active device group and the inactive device group of the change in Outcomes Measures in Rheumatology Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS) hand MRI index of synovitis



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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female and 22-75 years of age, inclusive
  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:

  1. Have taken the following within the defined time period prior to screening visit:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437473


Contacts
Contact: David Chernoff, MD 6617506140 dchernoff@setpointmedical.com
Contact: Erinne Wells, BA 6614259779 ewells@setpointmedical.com

Locations
United States, Florida
Arthritis & Rheumatic Disease Specialties Recruiting
Aventura, Florida, United States, 33180
Contact: Joanne Sagliani, CCRC    305-652-6676 ext 109    jsagliani@rheum-care.com   
Principal Investigator: Norman Gaylis, MD         
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33542
Contact: William D. Johnston, RN, CCRC    813-780-8368 ext 80150    wjohnston@floridamedicalclinic.com   
United States, New York
Northwell Health Division of Rheumatology Recruiting
Great Neck, New York, United States, 11021
Contact: Preeya Nandkumar    516-708-2556    pnandkumar@northwell.edu   
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Amber Woomer, LPN, CRC    814-693-0300 ext 156    AmberWoomer@altoonaresearch.com   
Contact: Renea Weyandt, RN, CRC    (814) 693-0300 ext 155    ReneaWeyandt@altoonaresearch.com   
Principal Investigator: Alan J Kivitz, MD, CPI         
Sponsors and Collaborators
SetPoint Medical Corporation
Investigators
Study Director: Mark Genovese, MD Stanford University

Responsible Party: SetPoint Medical Corporation
ClinicalTrials.gov Identifier: NCT03437473     History of Changes
Other Study ID Numbers: SPM-008
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs