Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04862117
• Other study ID #: SPM-011
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 28, 2018
• Est. completion date: January 8, 2022

Study information

• Verified date: April 2021
• Source: SetPoint Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID).

Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated.

From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment.

Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: January 8, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008

2. Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study

Exclusion Criteria:

1. Inability to provide consent

2. An adverse event during Study SPM-008 which precludes participation in this study

3. Any condition per the investigator's clinical judgement that precludes participation in the study

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Active Implantable Vagus Nerve Stimulation device.

Locations

Country	Name	City	State
United States	Arthritis & Rheumatic Disease Specialties	Aventura	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Northwell Health	Great Neck	New York
United States	Florida Medical Clinic, PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SetPoint Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)	Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)	Day 0 through Month 12
Secondary	American College of Rheumatology (ACR) 20, 50 and 70 response rates	Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status	Day 0 through Month 12
Secondary	European League Against Rheumatism (EULAR) response rates	Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None	Day 0 through Month 12
Secondary	Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate	Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission	Day 0 through Month 12