Rheumatoid ArthritisPhase 1/2NCT01552538
Long Term Extension Study For SPM-005 Participants
A Phase 1/2 study testing Cyberonics VNS System in people with Rheumatoid Arthritis, run by SetPoint Medical Corporation at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cyberonics VNS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2012to Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have participated in study SPM-005
Who cannot join
- Inability to provide informed consent
- Significant psychiatric illness or substance abuse
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Bosnia and Herzegovina2 sites
Sveučilišna klinička bolnica Mostar
Mostar
Klinicki Centar Univerziteta, Reumatologija
Sarajevo
Netherlands1 site
Academic Medical Center, University of Amsterdam
Amsterdam
About this study
Official title: Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis
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.
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cyberonics VNS System
- Keywords
- Rheumatoid Arthritis, Vagus Nerve, Vagal Nerve Stimulation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberonics VNS SystemDevice
Stimulation with an active implantable electrical vagal nerve stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Cyberonics VNS System | Experimental | Continued stimulation w/Cyberonics VNS Receives: Device: Cyberonics VNS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit
Measured: 12-18 months
Secondary outcomes (1)
Subject incidence of Adverse Events
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SetPoint Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Zitnik, M.D., Study director, SetPoint Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552538
- Sponsor's protocol ID
- SPM-006
- Status last verified
- Oct 2016
- First submitted
- 9 Mar 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01552538
- Acronym / sponsor ID
- SPM-006
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Vagus Nerve, Vagal Nerve Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- SetPoint Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyberonics VNS System | Experimental | Device: Cyberonics VNS SystemContinued stimulation w/Cyberonics VNS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have participated in study SPM-005
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Significant psychiatric illness or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberonics VNS SystemStimulation with an active implantable electrical vagal nerve stimulation device | Device | Cyberonics VNS System |
Primary outcome
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit
Time frame: 12-18 months
1 secondary outcome
Subject incidence of Adverse Events
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Zitnik, M.D. study director
SetPoint Medical
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyberonics VNS System in people with Rheumatoid Arthritis, run by SetPoint Medical Corporation at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bosnia and Herzegovina, Croatia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rheumatoid arthritis Disease Activity Score (DAS) from baseline visit (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.