Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

NCT04862117 · tracked via the Priya Life Science USA tracker

Sponsor

SetPoint Medical Corporation

Phase

Not applicable

Started

2018-07-28

Last updated

2026-08-27

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System: Active Implantable Vagus Nerve Stimulation device.

Study summary

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

Eligibility

Sex

ALL

Min age

22 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008 2. Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study Exclusion Criteria: 1. Inability to provide consent 2. An adverse event during Study SPM-008 which precludes participation in this study 3. Any condition per the investigator's clinical judgement that precludes participation in the study

Primary outcome measure(s)

Incidence rates of Adverse Events — Enrollment through Month 36 (End of Study)
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

Trial sites (4)

Facility	City	Region
Arthritis & Rheumatic Disease Specialties	Aventura	Florida
Florida Medical Clinic, PA	Zephyrhills	Florida
Northwell Health	Great Neck	New York
Altoona Center for Clinical Research	Duncansville	Pennsylvania

More SetPoint Medical Corporation trials in the USA

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis Active, not recruiting

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study Recruiting

Other trials for the same condition

A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis Recruiting

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis Active, not recruiting

A Study of AZD0120 in Autoimmune Diseases Recruiting

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA) Recruiting

An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04862117 on ClinicalTrials.gov ↗ ← All trials in the USA