Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: Cyberonics VNS System

• Registration Number: NCT01552941
• Lead Sponsor: SetPoint Medical Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vagal Nerve Stimulation	Cyberonics VNS System	-

Primary Outcome Measures

Name	Time	Method
Change in DAS from baseline	6 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patients with ACR 20 response	6 weeks

Trial Locations

Locations (4)

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Sveučilišna klinička bolnica Mostar; 🇧🇦 Mostar, Bosnia and Herzegovina

Klinicki Centar Univerziteta, Reumatologija; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Sisters of Mercy Clinical Hospital Centre; 🇭🇷 Zagreb, Croatia