Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
1 other identifier
interventional
14
1 country
4
Brief Summary
Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Jul 2018
Longer than P75 for not_applicable rheumatoid-arthritis
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2018
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 8, 2026
May 13, 2025
May 1, 2025
8.4 years
February 22, 2021
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence rates of Adverse Events
Treatment-emergent incidence rates of Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device Effects, and Unanticipated Serious Adverse Device Effects
Enrollment through Month 36 (End of Study)
Secondary Outcomes (4)
Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Day 0 through Month 12
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Day 0 through Month 12
European League Against Rheumatism (EULAR) response rates
Day 0 through Month 12
Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
Day 0 through Month 12
Study Arms (2)
Active stimulation QD
ACTIVE COMPARATORActive stimulation QID
ACTIVE COMPARATORInterventions
Active Implantable Vagus Nerve Stimulation device.
Eligibility Criteria
You may qualify if:
- Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
- Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study
You may not qualify if:
- Inability to provide consent
- An adverse event during Study SPM-008 which precludes participation in this study
- Any condition per the investigator's clinical judgement that precludes participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Northwell Health
Great Neck, New York, 11021, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Kivitz, MD
Altoona Center for Clinical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
April 27, 2021
Study Start
July 28, 2018
Primary Completion (Estimated)
December 8, 2026
Study Completion (Estimated)
December 8, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05