Long Term Extension Study For SPM-005 Participants
|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|
- Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
- Subject incidence of Adverse Events [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Cyberonics VNS System
Continued stimulation w/Cyberonics VNS
Device: Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552538
|Bosnia and Herzegovina|
|Sveučilišna klinička bolnica Mostar|
|Mostar, Bosnia and Herzegovina|
|Klinicki Centar Univerziteta, Reumatologija|
|Sarajevo, Bosnia and Herzegovina|
|Sisters of Mercy Clinical Hospital Centre|
|Academic Medical Center, University of Amsterdam|
|Study Director:||Ralph Zitnik, M.D.||SetPoint Medical|