This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).
Who Can Participate?
Inclusion Criteria:
22-75 years of age at screening
Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12
Exclusion Criteria:
Untreated or poorly controlled psychiatric illness or history of substance abuse
Significant immunodeficiency due to underlying illness
History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
Clinically significant cardiovascular disease
Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
Uncontrolled fibromyalgia
History of left or right carotid surgery
History of unilateral or bilateral vagotomy, partial or complete splenectomy