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

NCT ID: NCT04862117

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-28
• Study Completion Date: 2026-12-08

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

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active stimulation QD

Group Type: ACTIVE_COMPARATOR

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Intervention Type: DEVICE

Active Implantable Vagus Nerve Stimulation device.

Active stimulation QID

Group Type: ACTIVE_COMPARATOR

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Intervention Type: DEVICE

Active Implantable Vagus Nerve Stimulation device.

Interventions

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Active Implantable Vagus Nerve Stimulation device.

Intervention Type: DEVICE

Other Intervention Names

SetPoint System

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SetPoint Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Kivitz, MD

Role: PRINCIPAL_INVESTIGATOR

Altoona Center for Clinical Research

Locations

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, United States

Florida Medical Clinic, PA

Zephyrhills, Florida, United States

Northwell Health

Great Neck, New York, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Countries

United States

Other Identifiers

SPM-011

Identifier Type: -

Identifier Source: org_study_id