The RA PROTECTION Study

NCT04306744 | Completed FDA Device

• 1 other identifier: VC2020-7
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, double-blind, randomized, controlled pilot study to assess safety and efficacy of the Vorso PROTECT System in patients who have moderately to severely active rheumatoid arthritis. Eligible participants will be randomized in a 1:1 ratio of treatment to control (non- therapeutic) group after it has been determined they meet all of the inclusion criteria and none of the exclusion criteria. Both the treatment and control group participants will be asked to use the VORSO System once a day while maintaining a stable dose of methotrexate throughout the 12-week study. Participants will return to the site at 1, 6 and 12 weeks for follow-up testing.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR 20

  The percentage of participants achieving ACR 20 in the treatment vs. sham group

  12 weeks

Study Arms (2)

Vorso PROTECT System- ON

EXPERIMENTAL

The subject will use the Vorso PROTECT System daily. This experimental group will have the stimulation turned on for all of the daily sessions.

Device: Vorso PROTECT System

Sham Arm

SHAM COMPARATOR

The subject will use the Vorso PROTECT System daily. This experimental group will have the stimulation turned off for all of the daily sessions.

Device: Vorso PROTECT System - Sham (OFF)

Interventions

Vorso PROTECT System DEVICE

The Vorso PROTECT System is designed to deliver targeted, imperceptible, non-invasive stimulation to the ear to treat the signs and symptoms (e.g., tender and swollen joints, pain, synovitis) of patients with rheumatoid arthritis.

Vorso PROTECT System- ON

Vorso PROTECT System - Sham (OFF) DEVICE

Identical device to experimental arm, but the device will not deliver stimulation

Sham Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18 and 80 years of age at the time of enrollment
• Diagnosis of rheumatoid arthritis based on the 2010 EULAR/ACR criteria
• Diagnosis present for ≥3 months
• Have evidence of active disease, as defined by having at least 4 tender and 4 swollen joints in the TJC68 and SJC66, respectively
• Presence of rheumatoid factor or anti-CCP antibody at enrollment
• Must have an inadequate response to the maximum tolerated dose of 15-25 mg/week (unless lower dose is needed to due toxicity or physician discretion) of csDMARD/s for at least 12 weeks with a stable dose for at least 4 weeks prior to Baseline visit and have not been previously treated with a biologic
• Participants receiving a nonsteroidal anti-inflammatory drug (NSAID), prednisone or prednisone equivalent (10mg or less/day) or methotrexate must be on stable doses of these agents for more than 30 days prior to Baseline and remain stable for the duration of the study
• Able to operate the device appropriately and use it as per the protocol requirements
• Be willing and capable of giving informed consent
• Be willing and able to comply with research-related requirements, procedures, assessments and visits

You may not qualify if:

• Previously treated with any approved or investigational biologic agent (including TNF-, IL-1, IL-6, T-cell or B-cell targeted therapies) or tsDMARD
• History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia. Current diagnosis of secondary Sjogren's Syndrome is permitted.
• Have active disease involving the auricle or ear canal (e.g. otitis media, tinnitus, infection, perforated tympanic membrane, vestibular and/or balance, excessive cerumen production), unwilling to remove a piercing (e.g. daith or tragus), or use a device (e.g. hearing aid, cochlear implant) that would preclude daily use of the earpiece
• History of any clinically significant (as deemed by PI) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
• History of unilateral or bilateral vagotomy
• History of recurrent vasovagal syncope episodes
• Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the research or confounds the ability to interpret data from the research in the opinion of the Investigator
• Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
• Be pregnant or breast feeding (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
• Have symptomatic osteoarthritic knee issues within 30 days of enrollment
• Diagnosis of cancer (other than non-invasive skin cancer or carcinoma in-situ of the cervix) within the 5 years prior to research initiation
• Significant ECG findings (as determined by the Investigator), defined by:
• Ischemic changes (defined as \>1mm of down-sloping ST segment depression in at least two contiguous leads)
• Q-waves in at least two contiguous leads
• Clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome)

Sponsors & Collaborators

• Nesos Corp: lead

Study Sites (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• Baker MC, Kavanagh S, Cohen S, Matsumoto AK, Dikranian A, Tesser J, Kivitz A, Alataris K, Genovese MC. A Randomized, Double-Blind, Sham-Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Dec;75(12):2107-2115. doi: 10.1002/art.42637. Epub 2023 Nov 9.

  PMID: 37390360 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

• Alan Kivitz, MD

  Altoona Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, sham-controlled pilot study

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 13, 2020
• Study Start: September 1, 2020
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)