Long Term Extension Study For SPM-005 Participants
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed 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:
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Adverse events
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Serious adverse events
-
Device deficiencies
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cyberonics VNS System Continued stimulation w/Cyberonics VNS |
Device: Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device
|
Outcome Measures
Primary Outcome Measures
- Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit [12-18 months]
Secondary Outcome Measures
- Subject incidence of Adverse Events [12-18 months]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sveučilišna klinička bolnica Mostar | Mostar | Bosnia and Herzegovina | ||
| 2 | Klinicki Centar Univerziteta, Reumatologija | Sarajevo | Bosnia and Herzegovina | ||
| 3 | Sisters of Mercy Clinical Hospital Centre | Zagreb | Croatia | ||
| 4 | Academic Medical Center, University of Amsterdam | Amsterdam | Netherlands |
Sponsors and Collaborators
- SetPoint Medical Corporation
Investigators
- Study Director: Ralph Zitnik, M.D., SetPoint Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPM-006