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Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Cyberonics VNS System

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Vagus Nerve, Vagal Nerve Stimulation, Rheumatoid Arthritis, Implantable Medical Device

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sveučilišna klinička bolnica Mostar
Klinicki Centar Univerziteta, Reumatologija
Sisters of Mercy Clinical Hospital Centre
Academic Medical Center, University of Amsterdam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vagal Nerve Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Change in DAS from baseline

Secondary Outcome Measures

Number of patients with ACR 20 response

Full Information

NCT ID

NCT01552941

First Posted

March 8, 2012

Last Updated

October 28, 2016

Sponsor

SetPoint Medical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01552941

Brief Title

Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SetPoint Medical Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Vagus Nerve, Vagal Nerve Stimulation, Rheumatoid Arthritis, Implantable Medical Device

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vagal Nerve Stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Cyberonics VNS System

Intervention Description

Active Implantable Electrical Vagal Nerve Stimulator

Primary Outcome Measure Information:

Title

Change in DAS from baseline

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Number of patients with ACR 20 response

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul-Peter Tak, M.D., Ph.D.

Organizational Affiliation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sveučilišna klinička bolnica Mostar

City

Mostar

Country

Bosnia and Herzegovina

Facility Name

Klinicki Centar Univerziteta, Reumatologija

City

Sarajevo

Country

Bosnia and Herzegovina

Facility Name

Sisters of Mercy Clinical Hospital Centre

City

Zagreb

Country

Croatia

Facility Name

Academic Medical Center, University of Amsterdam

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27382171

Citation

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.

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Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

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