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

Active Not RecruitingNA

Sponsor: SetPoint Medical Corporation

Conditions: Rheumatoid Arthritis

Interventions: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Countries: United States

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 overview

Sex: ALL

Age: 22 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (4)

Aventura, Florida, United States
Zephyrhills, Florida, United States
Great Neck, New York, United States
Duncansville, Pennsylvania, United States