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Clinical Trials/NCT01552538
NCT01552538UnknownPhase 1

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

SetPoint Medical Corporation4 sites in 3 countries18 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
18
Locations
4
Primary Endpoint
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must have participated in study SPM-005

Exclusion Criteria

  • Inability to provide informed consent
  • Significant psychiatric illness or substance abuse

Outcomes

Primary Outcomes

Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit

Time Frame: 12-18 months

Secondary Outcomes

  • Subject incidence of Adverse Events(12-18 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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