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

NCT03437473 | Completed FDA Device

• 1 other identifier: SPM-008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• incidence of Adverse Events

  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

  Enrollment to Week 12

Secondary Outcomes (4)

• change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)

  change from baseline at Day 0 and Week 12

• change in American College of Rheumatology (ACR) 20, 50 and 70 response rates

  change from baseline at Day 0 and Week 12

• change in European League Against Rheumatism (EULAR) response and remission rate

  change from baseline at Day 0 and Week 12

• change in hand MRI

  change from baseline at Day 0 and Week 12

Study Arms (3)

Active stimulation QD

ACTIVE COMPARATOR

Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Active stimulation QID

ACTIVE COMPARATOR

Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

No stimulation

SHAM COMPARATOR

Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Interventions

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System DEVICE

Active Implantable Vagus Nerve Stimulation device.

Also known as: SetPoint System

Active stimulation QD; Active stimulation QID; No stimulation

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SetPoint Medical Corporation: lead

Study Sites (4)

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Florida Medical Clinic, P.A.

Zephyrhills, Florida, 33542, United States

Location

Northwell Health Division of Rheumatology

Great Neck, New York, 11021, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• 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.

  PMID: 38273617 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark Genovese, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: March 6, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)