Long Term Extension Study For SPM-005 Participants

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01552538
• Other study ID #: SPM-006
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 9, 2012
• Last updated: October 28, 2016
• Start date: January 2012
• Est. completion date: October 2018

Study information

• Verified date: October 2016
• Source: SetPoint Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportCroatia: Agency for Medicinal Product and Medical DevicesBosnia: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: October 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients must have participated in study SPM-005

Exclusion Criteria:

• Inability to provide informed consent

• Significant psychiatric illness or substance abuse

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device

Locations

Country	Name	City	State
Bosnia and Herzegovina	Sveucilišna klinicka bolnica Mostar	Mostar
Bosnia and Herzegovina	Klinicki Centar Univerziteta, Reumatologija	Sarajevo
Croatia	Sisters of Mercy Clinical Hospital Centre	Zagreb
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
SetPoint Medical Corporation

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Croatia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit		12-18 months	No
Secondary	Subject incidence of Adverse Events		12-18 months	Yes