An interventional study of SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System in Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation. Active, not recruiting at 4 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by SetPoint Medical Corporation · Not applicable, Interventional, and Treatment
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
A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID).
Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated.
From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment.
Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 14 is below the median of 96 across 2,220 interventional 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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Device: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.
Also known as: SetPoint System
Incidence rates of Adverse Events
Treatment-emergent incidence rates of Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device Effects, and Unanticipated Serious Adverse Device Effects
Time frame: Enrollment through Month 36 (End of Study)
Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Time frame: Day 0 through Month 12
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status
Time frame: Day 0 through Month 12
European League Against Rheumatism (EULAR) response rates
Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None
Time frame: Day 0 through Month 12
Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission
Time frame: Day 0 through Month 12
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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SetPoint Medical Corporation