Clinical trial NCT01552538: Long Term Extension Study For SPM-005 Participants
Official title: Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Vagus Nerve
Vagal Nerve Stimulation
Lead sponsor: SetPoint Medical Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* Patients must have participated in study SPM-005

Exclusion Criteria:

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

Primary outcomes:
measure: Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit
timeFrame: 12-18 months
Secondary outcomes:
measure: Subject incidence of Adverse Events
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: Sveučilišna klinička bolnica Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Klinicki Centar Univerziteta, Reumatologija
city: Zagreb
country: Croatia
facility: Sisters of Mercy Clinical Hospital Centre
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
Study officials:
affiliation: SetPoint Medical
name: Ralph Zitnik, M.D.
role: STUDY_DIRECTOR
References: