Clinical trial NCT04862117: Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Official title: Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: SetPoint Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence rates of Adverse Events
timeFrame: Enrollment through Month 36 (End of Study)
Secondary outcomes:
measure: Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
timeFrame: Day 0 through Month 12
measure: American College of Rheumatology (ACR) 20, 50 and 70 response rates
timeFrame: Day 0 through Month 12
measure: European League Against Rheumatism (EULAR) response rates
timeFrame: Day 0 through Month 12
measure: Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
timeFrame: Day 0 through Month 12
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: Altoona Center for Clinical Research
name: Alan Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
References: