Long Term Extension Study For SPM-005 Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Cyberonics VNS System


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Vagus Nerve, Vagal Nerve Stimulation