An observational study in Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by SetPoint Medical Corporation · Observational
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 150 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →SetPoint Medical Corporation is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted
Device: SetPoint System
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)
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
Time frame: 3 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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SetPoint Medical Corporation