Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis
NCT ID: NCT01552941
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2011-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vagal Nerve Stimulation
Cyberonics VNS System
Active Implantable Electrical Vagal Nerve Stimulator
Interventions
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Cyberonics VNS System
Active Implantable Electrical Vagal Nerve Stimulator
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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SetPoint Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Paul-Peter Tak, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Sveučilišna klinička bolnica Mostar
Mostar, , Bosnia and Herzegovina
Klinicki Centar Univerziteta, Reumatologija
Sarajevo, , Bosnia and Herzegovina
Sisters of Mercy Clinical Hospital Centre
Zagreb, , Croatia
Academic Medical Center, University of Amsterdam
Amsterdam, , Netherlands
Countries
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References
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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. Epub 2016 Jul 5.
Other Identifiers
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SPM-005
Identifier Type: -
Identifier Source: org_study_id