Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

SetPoint Medical

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Device: Cyberonics VNS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01552941

SPM-005

Details and patient eligibility

About

This is a 12 week open label pilot study to determine the efficacy and safety of a surgically implanted, electrically active vagal nerve stimulation device in patients with active rheumatoid arthritis.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult-onset rheumatoid arthritis of at least six months duration as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
Male or female patients, 18-75 years of age, inclusive
Functional status I, II, or III as classified according to the ACR 1991 revised criteria (Hochberg, 1992)
Patients must have active disease as defined by at least 4 active tender or swollen joints and CRP above 0.7 mg/dL, despite at least 3 months of treatment with methotrexate at a dose of up to 25 mg orally per week.
Patients may have been previously treated with TNF antagonists, but must have failed by reason of inadequate safety, intolerance to side effects, or development of antibodies (i.e., secondary failures), and specifically cannot have failed on the basis of primary lack of efficacy
Study amended to add a second cohort of up to 10 patients who have failed both a TNF antagonist and at least one other biological therapy having a non-TNF antagonist mechanism of action

Exclusion criteria

History of unilateral or bilateral vagotomy
History of recurrent vaso-vagal syncope episodes
Known obstructive sleep apnea
Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block
Significant pharyngeal dysfunction or swallowing difficulties
Pre-existing clinically significant vocal cord damage or hoarseness
Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea at time of screening
Active peptic ulcer disease