Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment cyberonics vns system
Phase phase 1/phase 2
Sponsor SetPoint Medical Corporation
Start date January 2012
End date May 2018
Trial size 18 participants
Trial identifier NCT01552538, SPM-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Continued stimulation w/Cyberonics VNS
cyberonics vns system
Stimulation with an active implantable electrical vagal nerve stimulation device

Primary Outcomes

Measure
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit
time frame: 12-18 months

Secondary Outcomes

Measure
Subject incidence of Adverse Events
time frame: 12-18 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patients must have participated in study SPM-005 Exclusion Criteria: - Inability to provide informed consent - Significant psychiatric illness or substance abuse

Additional Information

Official title Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by SetPoint Medical Corporation.