Rheumatoid Arthritis
Conditions
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.
Interventions
Active Implantable Vagus Nerve Stimulation device.
Sponsors
SetPoint Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates of Adverse Events | Enrollment through Month 36 (End of Study) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP) | Day 0 through Month 12 | Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP) |
| American College of Rheumatology (ACR) 20, 50 and 70 response rates | Day 0 through Month 12 | Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status |
| European League Against Rheumatism (EULAR) response rates | Day 0 through Month 12 | Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None |
| Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate | Day 0 through Month 12 | Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlan Kivitz, MD
Altoona Center for Clinical Research
Outcome results
None listed