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

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

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