The SetPoint System Safety & Performance Post-Approval 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SetPoint System

Device

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)

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vickie Haines

CONTACT

[email protected]

661-750-6140

Sponsors and collaborators

Lead sponsor

SetPoint Medical Corporation

Industry

Registry information

Official study title

The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)

Acronym: ACTIVATE

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Mar 24, 2026
Registry last updated: Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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