Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Pilot Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-Inflammatory Pathway Using an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552941
• Other study ID #: SPM-005
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: October 28, 2016
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: SetPoint Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Cyberonics VNS System
Active Implantable Electrical Vagal Nerve Stimulator

Locations

Country	Name	City	State
Bosnia and Herzegovina	Sveucilišna klinicka bolnica Mostar	Mostar
Bosnia and Herzegovina	Klinicki Centar Univerziteta, Reumatologija	Sarajevo
Croatia	Sisters of Mercy Clinical Hospital Centre	Zagreb
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
SetPoint Medical Corporation

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Croatia,  Netherlands, 

References & Publications (1)

Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DAS from baseline		6 weeks	No
Secondary	Number of patients with ACR 20 response		6 weeks	No