Long Term Extension Study For SPM-005 Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SetPoint Medical Corporation
ClinicalTrials.gov Identifier:
NCT01552538
First received: March 9, 2012
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Device: Cyberonics VNS System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by SetPoint Medical Corporation:

Primary Outcome Measures:
  • Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject incidence of Adverse Events [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: January 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vagal Nerve Stimulation with Cyberonics VNS system
Continued stimulation with the same Cyberonics vagal nerve stimulation device that was previously implanted during prior study SPM-005
Device: Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device

Detailed Description:

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 and 24 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 24 months on study. The study will continue until the last patient entered has completed 24 months in this study. An Interim Visit must be performed a maximum of 1 month 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 24 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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have participated in study SPM-005

Exclusion Criteria:

  • Inability to provide informed consent
  • Significant psychiatric illness or substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552538

Locations
Bosnia and Herzegovina
Sveučilišna klinička bolnica Mostar
Mostar, Bosnia and Herzegovina
Klinicki Centar Univerziteta, Reumatologija
Sarajevo, Bosnia and Herzegovina
Croatia
Sisters of Mercy Clinical Hospital Centre
Zagreb, Croatia
Netherlands
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
SetPoint Medical Corporation
  More Information

No publications provided

Responsible Party: SetPoint Medical Corporation
ClinicalTrials.gov Identifier: NCT01552538     History of Changes
Other Study ID Numbers: SPM-006
Study First Received: March 9, 2012
Last Updated: May 18, 2015
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Croatia: Agency for Medicinal Product and Medical Devices
Bosnia: Federal Ministry of Health

Keywords provided by SetPoint Medical Corporation:
Rheumatoid Arthritis
Vagus Nerve
Vagal Nerve Stimulation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 05, 2015