Vagus Nerve Stimulation for Rheumatoid Arthritis

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SetPoint Medical Corporation

Disqualifiers: Inability to consent, adverse event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action

Research Team

Alan Kivitz, MD

Principal Investigator

Altoona Center for Clinical Research

Eligibility Criteria

This trial is for adults with moderate-to-severe rheumatoid arthritis who didn't fully respond to at least two advanced treatments. Participants must have completed a prior 12-week treatment in Study SPM-008 and, if they can bear children, agree to use reliable contraception during the study.

Inclusion Criteria

Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study

I completed 12 weeks in Study SPM-008.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active vagus nerve stimulation with output current adjustments during the initial weeks

5 weeks

Visits at Day 0, Week 1, 2, 3, 4, and 5

Long-term Treatment

Participants continue receiving maximally tolerated output current as 1 min QD or 1 min QID treatment

31 months

Follow-up visits at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Trial Overview The trial is testing the long-term safety and effectiveness of a Vagus Nerve Stimulation (VNS) device by SetPoint Medical. It's designed for patients whose arthritis hasn't improved enough with previous drug therapies.

Participant Groups

Group I: Active stimulation QD Active Control 1 Intervention

Group II: Active stimulation QID Active Control 1 Intervention

Who Is Running the Clinical Trial?

SetPoint Medical Corporation

Lead Sponsor

Trials

8

Recruited

400+