NCT01552538

Brief Summary

This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis. Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1 rheumatoid-arthritis

Geographic Reach
3 countries

4 active sites

Status
unknown

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

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

6.3 years

First QC Date

March 9, 2012

Last Update Submit

October 28, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisVagus NerveVagal Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit

    12-18 months

Secondary Outcomes (1)

  • Subject incidence of Adverse Events

    12-18 months

Study Arms (1)

Cyberonics VNS System

EXPERIMENTAL

Continued stimulation w/Cyberonics VNS

Device: Cyberonics VNS System

Interventions

Cyberonics VNS SystemDEVICE

Stimulation with an active implantable electrical vagal nerve stimulation device

Cyberonics VNS System

Eligibility Criteria

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

You may qualify if:

  • Patients must have participated in study SPM-005

You may not qualify if:

  • Inability to provide informed consent
  • Significant psychiatric illness or substance abuse

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ralph Zitnik, M.D.

    SetPoint Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2018

Study Completion

October 1, 2018

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

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