The SetPoint System Safety & Performance Post-Approval Study
ConditionRheumatoid Arthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorSetPoint Medical Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indicated for the SetPoint System
Implant procedure for the SetPoint System has been attempted
Willing to sign Informed Consent Form
Disqualifiers
Contraindicated for the SetPoint System
Trial 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).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
SetPoint System
Deviceimplanted, 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)
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: SetPoint System users1 intervention
Trial outcomes
Primary outcomes
1
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 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: