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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862117
Recruitment Status : Active, not recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
SetPoint Medical Corporation

Study Description
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Brief Summary:
Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having 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:

A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID).

Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated.

From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment.

Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Actual Study Start Date : July 28, 2018
Estimated Primary Completion Date : January 8, 2022
Estimated Study Completion Date : January 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rates of Adverse Events [ Time Frame: Enrollment through Month 36 (End of Study) ]
    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: Day 0 through Month 12 ]
    Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)

  2. American College of Rheumatology (ACR) 20, 50 and 70 response rates [ Time Frame: Day 0 through Month 12 ]
    Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status

  3. European League Against Rheumatism (EULAR) response rates [ Time Frame: Day 0 through Month 12 ]
    Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None

  4. Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate [ Time Frame: Day 0 through Month 12 ]
    Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission


Eligibility Criteria
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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. Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
  2. Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study

Exclusion Criteria:

  1. Inability to provide consent
  2. An adverse event during Study SPM-008 which precludes participation in this study
  3. Any condition per the investigator's clinical judgement that precludes participation in the study
Contacts and Locations
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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): NCT04862117


Locations
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United States, Florida
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Florida Medical Clinic, PA
Zephyrhills, Florida, United States, 33542
United States, New York
Northwell Health
Great Neck, New York, United States, 11021
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
SetPoint Medical Corporation
Investigators
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Principal Investigator: Alan Kivitz, MD Altoona Center for Clinical Research
More Information
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Responsible Party: SetPoint Medical Corporation
ClinicalTrials.gov Identifier: NCT04862117    
Other Study ID Numbers: SPM-011
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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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
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