Rheumatoid ArthritisNCT04862117
Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
A study testing SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System in people with Rheumatoid Arthritis, run by SetPoint Medical Corporation at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jul 2018to 8 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
- Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study
Who cannot join
- Inability to provide consent
- An adverse event during Study SPM-008 which precludes participation in this study
- Any condition per the investigator's clinical judgement that precludes participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Northwell Health
Great Neck, New York, 11021
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
About this study
Official title: Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
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
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway SystemDevice
Also called SetPoint System
Active Implantable Vagus Nerve Stimulation device.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation QD | Active comparator | Not described Receives: Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System |
| Active stimulation QID | Active comparator | Not described Receives: Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates 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
Measured: Enrollment through Month 36 (End of Study)
Secondary outcomes (4)
Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Measured: Day 0 through Month 12
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status
Measured: Day 0 through Month 12
European League Against Rheumatism (EULAR) response rates
Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None
Measured: Day 0 through Month 12
Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission
Measured: Day 0 through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start28 Jul 2018
- Primary completion8 Dec 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- SetPoint Medical Corporation
- 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
- NCT04862117
- Sponsor's protocol ID
- SPM-011
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04862117
- Acronym / sponsor ID
- SPM-011
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- SetPoint Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 27 Apr 2021 (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.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
- Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study
Key exclusion criteria (3 listed)
- Inability to provide consent
- An adverse event during Study SPM-008 which precludes participation in this study
- Any condition per the investigator's clinical judgement that precludes participation in the study
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 |
|---|---|---|
| SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway SystemAlso: SetPoint SystemActive Implantable Vagus Nerve Stimulation device. | Device | Active stimulation QD, Active stimulation QID |
Primary outcome
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
4 secondary outcomes
Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Time frame: Day 0 through Month 12
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Time frame: Day 0 through Month 12
European League Against Rheumatism (EULAR) response rates
Time frame: Day 0 through Month 12
Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
Time frame: Day 0 through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System in people with Rheumatoid Arthritis, run by SetPoint Medical Corporation at 4 sites 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence rates of Adverse Events (time frame: Enrollment through Month 36 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.