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

Exclusion Criteria

• •1. Have taken the following within the defined time period prior to screening visit:
• •i. Rituximab: 6 months ii. Infliximab, golimumab, adalimumab, certolizumab pegol, tocilizumab: 60 days iii. Abatacept, etanercept, anakinra: 30 days iv. Tofacitinib: 30 days v. Investigational biologic agents: 6 months for depleting agents, 60 days for others vi. Investigational small molecules: 5 times the pharmacokinetic half-life or 30 days, whichever is longer vii. Intra-articular corticosteroid injection: 30 days
• •2. Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening visit
• •3. Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of screening visit
• •4. Documented significant psychiatric illness or substance abuse
• •5. Active infection requiring treatment with antibiotics
• •6. Uncontrolled hypertension
• •7. Uncontrolled diabetes
• •8. History of stroke
• •9. Known cardiac disease, including cardiomyopathy with ejection fraction \<40%, recent myocardial infarction or unstable angina, or heart failure with New York Heart Association class III or IV symptoms
• •10. Known neurological syndromes
• •11. Known atherosclerotic disease including contralateral carotid artery
• •12. BMI \<18.5 or \>35
• •13. Any condition per the investigator's clinical judgment that precludes participation in the study