Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Vagus nerve, vagus nerve stimulating device, permanent implantable, implant
Brief 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). 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.
Interventions
DEVICESetPoint 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)
Sponsors
SetPoint Medical Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indicated for the SetPoint System * Implant procedure for the SetPoint System has been attempted * Willing to sign Informed Consent Form
Exclusion criteria
* Contraindicated for the SetPoint System
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Disease Activity Index (CDAI) | 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 |
Contacts
CONTACTVickie Haines
Outcome results
None listed