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NCT03437473
Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
NA trial testing SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System in Rheumatoid Arthritis in 14 participants. Completed in 10 December 2018.
10 December 2018
Quick facts
| Lead sponsor | SetPoint Medical Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | device feasibility |
| Enrollment | 14 |
| Start date | 6 March 2018 |
| Primary completion | 10 December 2018 |
| Estimated completion | 10 December 2018 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
SetPoint Medical Corporation — full company profile →
Who can join
Adults 22 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and efficacy of neurostimulation with a miniaturised vagus nerve stimulation device in patients with multidrug-refractory rheumatoid arthritis: a two-stage multicentre, randomised pilot study.
Genovese MC, Gaylis NB, Sikes D, Kivitz A, et al · · 2020 · cited 83× · PMID 38273617 · DOI 10.1016/s2665-9913(20)30172-7 -
Neuroimmunomodulation of vagus nerve stimulation and the therapeutic implications.
Fang YT, Lin YT, Tseng WL, Tseng P, et al · · 2023 · cited 61× · PMID 37484689 · DOI 10.3389/fnagi.2023.1173987 -
The Evolution of Neuromodulation in the Treatment of Chronic Pain: Forward-Looking Perspectives.
Fishman MA, Antony A, Esposito M, Deer T, et al · · 2019 · cited 44× · PMID 31152176 · DOI 10.1093/pm/pnz074 -
Harnessing the Inflammatory Reflex for the Treatment of Inflammation-Mediated Diseases.
Levine YA, Faltys M, Chernoff D. · · 2020 · cited 18× · PMID 30833463 · DOI 10.1101/cshperspect.a034330 -
Vagus nerve stimulation: Novel concept for the treatment of glioblastoma and solid cancers by cytokine (interleukin-6) reduction, attenuating the SASP, enhancing tumor immunity.
Brem S. · · 2024 · cited 14× · PMID 39512605 · DOI 10.1016/j.bbih.2024.100859 -
Abdominal vagus nerve stimulation alleviates collagen-induced arthritis in rats.
Payne SC, Romas E, Hyakumura T, Muntz F, et al · · 2022 · cited 5× · PMID 36478876 · DOI 10.3389/fnins.2022.1012133 -
Macrophages as central mediators of sympathetic neuro-immune interplay in autoimmunity.
Muntjewerff EM, Josyula VS, Lehmair F, Christoffersson G. · · 2025 · PMID 41476959 · DOI 10.3389/fimmu.2025.1654382
Verify or expand the search:
- PubMed search for NCT03437473
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Trials testing the same drug.
- NCT04862117 — Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) · NA · active not recruiting
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other SetPoint Medical Corporation trials
Trials by the same sponsor.
- NCT07489326 — The SetPoint System Safety & Performance Post-Approval Study · not yet recruiting
- NCT06796504 — The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study · NA · recruiting
- NCT04862117 — Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03437473 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SetPoint Medical Corporation
- Last refreshed: 27 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03437473.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing