ong Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis
Phase 2
Completed
- Conditions
- painful swollen joints10003816
- Registration Number
- NL-OMON43838
- Lead Sponsor
- SetPoint Medical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
Inclusion Criteria
Patients must have participated in study SPM-005, including patients who either completed that study or withdrew before completion of that study.
Exclusion Criteria
Inability to provide informed consent;Significant psychiatric illness or substance abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>• Change in DAS 28 score from the baseline of the preceding study (SPM-005) to<br /><br>each follow-up visit</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints<br /><br>• The ACR 20, ACR 50, and ACR 70 response rates calculated based on RA<br /><br>assessments at the baseline of the preceding study compared to those at each<br /><br>follow-up visit on the current study<br /><br>• The EULAR response rate calculated based on RA assessments at the baseline of<br /><br>the preceding study compared to those at each follow-up visit on the current<br /><br>study<br /><br>• Change in Euro-QoL score from the baseline of the preceding study to each<br /><br>follow-up visit<br /><br><br /><br>Safety Endpoints<br /><br>The following Safety Endpoints will be assessed:<br /><br>• Adverse Events<br /><br>• Serious Adverse Events<br /><br>• Device Deficiencies</p><br>