Long Term Extension Study For SPM-005 Participants

October 28, 2016 updated by: SetPoint Medical Corporation

Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-005 and greater than 30 days have elapsed since the final visit in SPM-005, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.

Follow-up visits will occur at 3, 6, 12, 18, 24, 36 and 48 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 48 months on study.

The study will continue until the last patient entered has completed 48 months in this study.

An Interim Visit or a phone contact must be performed a maximum of 2 months after any change in device settings. Interim visits may also be performed at any time at the investigator's discretion; either between scheduled visits, or after the patient has completed the Month 48 Visit, if the study is still ongoing.

The primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.

The secondary efficacy objectives are to determine the long term efficacy of vagal nerve stimulation as assessed by:

  • the ACR 20, 50 and 70 response rate,
  • the EULAR response rate, and
  • changes in the Euro-QoL score.

The safety objectives are to determine the long term safely of vagal nerve stimulation as assessed by the subject incidence rates of:

  • Adverse events
  • Serious adverse events
  • Device deficiencies

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina
        • Sveučilišna klinička bolnica Mostar
      • Sarajevo, Bosnia and Herzegovina
        • Klinicki Centar Univerziteta, Reumatologija
  • Croatia
      • Zagreb, Croatia
        • Sisters of Mercy Clinical Hospital Centre
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center, University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have participated in study SPM-005

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyberonics VNS System
Continued stimulation w/Cyberonics VNS
Device: Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit
Time Frame: 12-18 months
12-18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject incidence of Adverse Events
Time Frame: 12-18 months
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SetPoint Medical Corporation

Investigators

  • Study Director: Ralph Zitnik, M.D., SetPoint Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPM-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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