Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03437473 |
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Recruitment Status :
Recruiting
First Posted : February 19, 2018
Last Update Posted : May 10, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System | Not Applicable |
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 |
| 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 |
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female and 22-75 years of age, inclusive
- Have provided informed consent
- Have a diagnosis of adult-onset rheumatoid arthritis as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
- Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints and CDAI score >10
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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:
- experienced insufficient efficacy or loss of efficacy
- experienced intolerance of such treatment
- 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
- 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:
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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
- 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
- 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
- Documented significant psychiatric illness or substance abuse
- Active infection requiring treatment with antibiotics
- Uncontrolled hypertension
- Uncontrolled diabetes
- History of stroke
- 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
- Known neurological syndromes
- Known atherosclerotic disease including contralateral carotid artery
- BMI <18.5 or >35
- Any condition per the investigator's clinical judgment that precludes participation in the study
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
| Contact: David Chernoff, MD | 6617506140 | dchernoff@setpointmedical.com | |
| Contact: Erinne Wells, BA | 6614259779 | ewells@setpointmedical.com |
| 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 | |
| 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:
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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 |