Rheumatoid ArthritisNCT04306744
The RA PROTECTION Study
A study testing Vorso PROTECT System in people with Rheumatoid Arthritis, run by Nesos Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Vorso PROTECT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
- Participants receiving intraarticular, intramuscular, or intravenous glucocorticoids within 4 weeks prior to Baseline (unless participant is on stable dose of prednisone as per inclusion above) or if it is anticipated that the participant will need glucocorticoids at some point during the expected study duration
- 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
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- 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)
- Clinically significant arrhythmias (e.g., current atrial fibrillation)
- Bradyarrhythmias (e.g. Type I or type II block)
- Have been hospitalized for psychiatric disorder or attempted suicide within the last 12 months
- History of concurrent illness that requires hospitalization within 30 days prior to Baseline
- Have skin and vascular problems such as infected areas of skin, skin eruptions, dermatological conditions, open wounds or damaged or broken skin in the area where stimulation is planned
- Have uncontrolled hypertension or hypotension
- History or current abuse of or dependence on alcohol or drugs that would interfere with the results or adherence to research requirements based on the judgement of the Investigator
- Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the participant at risk
- Any language barrier that, in the opinion of the Investigator, would preclude communication and compliance with the research requirements
- Participation in another investigational trial during the 30 days prior to research initiation or during this study
- Any other household member currently participating in Vorso research or relative of site staff member
- If the investigator believes there is any reason that the participant will not be compliant with the study requirements and completion of evaluations
Trial locations and contacts
1 site in 1 country.
United States1 site
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
About this study
Official title: Researching the Safety and Efficacy the Vorso PROTECT System for the Treatment of Subjects With Active Rheumatoid Arthritis Who Are naïve to Biologic or Synthetic Disease Modifying Agents
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
- Being tested
- Vorso PROTECT System, Vorso PROTECT System - Sham (OFF)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorso PROTECT SystemDevice
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 - Sham (OFF)Device
Identical device to experimental arm, but the device will not deliver stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Vorso PROTECT System - Sham (OFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 20
The percentage of participants achieving ACR 20 in the treatment vs. sham group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Sep 2020
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, sham-controlled pilot study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nesos Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Kivitz, MD, Principal investigator, Altoona Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306744
- Sponsor's protocol ID
- VC2020-7
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37390360
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Safety and Efficacy the Vorso PROTECT System for the Treatment of Subjects With Active Rheumatoid Arthritis Who Are naïve to Biologic or Synthetic Disease Modifying Agents
- ClinicalTrials.gov ID
- NCT04306744
- Acronym / sponsor ID
- VC2020-7
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Nesos CorpIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, randomized, sham-controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Vorso PROTECT System- ON | Experimental | Device: Vorso PROTECT SystemThe subject will use the Vorso PROTECT System daily. This experimental group will have the stimulation turned on for all of the daily sessions. |
| Sham Arm | Sham comparator | Device: Vorso PROTECT System - Sham (OFF)The subject will use the Vorso PROTECT System daily. This experimental group will have the stimulation turned off for all of the daily sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
- Participants receiving intraarticular, intramuscular, or intravenous glucocorticoids within 4 weeks prior to Baseline (unless participant is on stable dose of prednisone as per inclusion above) or if it is anticipated that the participant will need glucocorticoids at some point during the expected study duration
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vorso PROTECT SystemThe 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. | Device | Vorso PROTECT System- ON |
| Vorso PROTECT System - Sham (OFF)Identical device to experimental arm, but the device will not deliver stimulation | Device | Sham Arm |
Primary outcome
ACR 20
Time frame: 12 weeks
The percentage of participants achieving ACR 20 in the treatment vs. sham group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 37390360Baker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Kivitz, MD principal investigator
Altoona Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vorso PROTECT System in people with Rheumatoid Arthritis, run by Nesos Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 20 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023; AzTrials last refreshed its copy on 3 Nov 2026.