Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 8
- 主要终点
- Incidence rates of Adverse Events
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence rates of Adverse Events
时间窗: 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
次要结局
- Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate(Day 0 through Month 12)
- European League Against Rheumatism (EULAR) response rates(Day 0 through Month 12)
- 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)