Safety and Efficacy Vagal Nerve Stimulation in Patients W... | NCT01552941

Studies
Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

NCT01552941

Sponsor

SetPoint Medical Corporation

Status

Completed

Last Update Posted

Nov 1, 2016Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

Cyberonics VNS System

Countries

Bosnia and Herzegovina
Croatia
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Mar 8, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Label	Type	Description	Intervention Names
Vagal Nerve Stimulation	Experimental		Device: Cyberonics VNS System

Name	Type	Description	Arm Group Labels	Other Names
Cyberonics VNS System	Device	Active Implantable Electrical Vagal Nerve Stimulator	Vagal Nerve Stimulation

Measure	Description	Time Frame
Change in DAS from baseline		6 weeks

Measure	Description	Time Frame
Number of patients with ACR 20 response		6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Paul-Peter Tak, M.D., Ph.D.	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sveučilišna klinička bolnica Mostar		Mostar			Bosnia and Herzegovina
Klinicki Centar Univerziteta, Reumatologija

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27382171	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases