NCT01552941

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

March 8, 2012

Last Update Submit

October 28, 2016

Conditions

Rheumatoid Arthritis

Keywords

Vagus NerveVagal Nerve StimulationRheumatoid ArthritisImplantable Medical Device

Outcome Measures

Primary Outcomes (1)

  • Change in DAS from baseline

    6 weeks

Secondary Outcomes (1)

  • Number of patients with ACR 20 response

    6 weeks

Study Arms (1)

Vagal Nerve Stimulation

EXPERIMENTAL
Device: Cyberonics VNS System

Interventions

Cyberonics VNS SystemDEVICE

Active Implantable Electrical Vagal Nerve Stimulator

Vagal Nerve Stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sveučilišna klinička bolnica Mostar

Mostar, Bosnia and Herzegovina

Location

Klinicki Centar Univerziteta, Reumatologija

Sarajevo, Bosnia and Herzegovina

Location

Sisters of Mercy Clinical Hospital Centre

Zagreb, Croatia

Location

Academic Medical Center, University of Amsterdam

Amsterdam, Netherlands

Location

Related 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. Epub 2016 Jul 5.

    PMID: 27382171BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paul-Peter Tak, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 13, 2012

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BO(2)NL(1)CR(1)