Rheumatoid ArthritisACTIVATENCT07489326
The SetPoint System Safety & Performance Post-Approval Study
An observational study of Rheumatoid Arthritis, run by SetPoint Medical Corporation.
Trial summary
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SetPoint System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 1 Jan 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs).
Who may be able to join
- Indicated for the SetPoint System
- Implant procedure for the SetPoint System has been attempted
- Willing to sign Informed Consent Form
Who cannot join
- Contraindicated for the SetPoint System
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.
Read the detailed description
The registry will follow a prospective, multi-center, observational design with data collection at predefined intervals for up to three (3) years. All participants will have received the SetPoint System as part of routine clinical care, and no study-specific interventions are required. Data about the surgical procedure will be obtained from training records, implant procedure checklists, and other available records and entered into study-specific electronic case report forms (eCRFs). Additionally, data will be captured during scheduled follow-up at the Rheumatology clinic, using a combination of study-specific worksheets and the automatic transfer of device-specific performance data that is captured in the SetPoint Cloud Infrastructure. User feedback (including both complaints and non-complaints) will also be collected. The compilation of this data will allow monitoring of safety, effectiveness, device performance, and usability in a real-world setting.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SetPoint System
- Keywords
- Rheumatoid Arthritis, Vagus nerve, vagus nerve stimulating device, permanent implantable, implant
- 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 SystemDevice
implanted, vagus-mediated neuroimmune modulator for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs)
| Study group | Role | What they receive |
|---|---|---|
| SetPoint System users | Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted Receives: Device: SetPoint System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Disease Activity Index (CDAI)
The CDAI score is based on 4 items:
- Tender joint count of 28 joints (TJC28). Scale: 0=best to 28=worst
- Swollen joint count of 28 joints (SJC28). Scale: 0=best to 28=worst
- Subject global assessment (SGA). Scale: 0=best to 10=worst
- Evaluator's global assessment (EGA). Scale: 0=best to 10=worst
The CDAI score is calculated as follows and ranges from 0 to 76:
- CDAI = TJC28 + SJC28 + SGA + EGA
The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- SetPoint Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489326
- Sponsor's protocol ID
- SPM-021
- Acronym
- ACTIVATE
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)
- ClinicalTrials.gov ID
- NCT07489326
- Acronym / sponsor ID
- ACTIVATE / SPM-021
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Vagus nerve, vagus nerve stimulating device, permanent implantable, implant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SetPoint Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 24 Mar 2026 (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.
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.
Detailed description
The registry will follow a prospective, multi-center, observational design with data collection at predefined intervals for up to three (3) years. All participants will have received the SetPoint System as part of routine clinical care, and no study-specific interventions are required. Data about the surgical procedure will be obtained from training records, implant procedure checklists, and other available records and entered into study-specific electronic case report forms (eCRFs). Additionally, data will be captured during scheduled follow-up at the Rheumatology clinic, using a combination of study-specific worksheets and the automatic transfer of device-specific performance data that is captured in the SetPoint Cloud Infrastructure. User feedback (including both complaints and non-complaints) will also be collected. The compilation of this data will allow monitoring of safety, effectiveness, device performance, and usability in a real-world setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SetPoint System users | – | Device: SetPoint SystemPatients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs).
Key inclusion criteria (3 listed)
- Indicated for the SetPoint System
- Implant procedure for the SetPoint System has been attempted
- Willing to sign Informed Consent Form
Key exclusion criteria (1 listed)
- Contraindicated for the SetPoint System
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 Systemimplanted, vagus-mediated neuroimmune modulator for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs) | Device | SetPoint System users |
Primary outcome
Clinical Disease Activity Index (CDAI)
Time frame: 3 years
The CDAI score is based on 4 items: * Tender joint count of 28 joints (TJC28). Scale: 0=best to 28=worst * Swollen joint count of 28 joints (SJC28). Scale: 0=best to 28=worst * Subject global assessment (SGA). Scale: 0=best to 10=worst * Evaluator's global assessment (EGA). Scale: 0=best to 10=worst The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * >2.8 to ≤ 10 Low disease activity (LDA) * >10 to ≤ 22 Moderate disease activity * > 22 High disease activity
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 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by SetPoint Medical Corporation.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Vickie Haines (661-750-6140, vhaines@setpointmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Disease Activity Index (CDAI) (time frame: 3 years). 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 24 Mar 2026.