NL-OMON35837招募中不适用
Pilot Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-Inflammatory Pathway Using an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis - SPM-005
Setpoint Medical0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Adult-onset rheumatoid arthritis of at least six months duration as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
- •* Male or female patients, 18-75 years of age, inclusive
- •* Functional status I, II, or III as classified according to the ACR 1991 revised criteria (Hochberg, 1992)
- •* Patients must have active disease as defined by at least 4 active tender or swollen joints and CRP above 1.5 mg/dL, despite at least 3 months of treatment with methotrexate at a dose of up to 25 mg orally per week.
- •* Patients may have been previously treated with TNF antagonists, but must have failed by reason of inadequate safety, intolerance to side effects, or development of antibodies (i.e., secondary failures), and specifically must not have failed due to lack of efficacy (i.e., primary failures, defined as non-responders after at least 16 weeks of treatment). Such patients must have had a washout period of at least 6 weeks for etanercept, and at least 12 weeks for infliximab, adalimumab, golimumab, or certolizumab pegol prior to enrollment.
- •* At the discretion of the sponsor and the investigators, up to 2 of the patients enrolled may be patients who have failed both a TNF antagonist (either a primary or a secondary failure), AND have failed at least one other biological therapy having a non-TNF antagonist mechanism of action. Such patients may continue to use their current biologic therapy during the course of the study.
- •* Patients must have normal Screening Visit studies. Patients with abnormal but clinically insignificant Screening Visit studies may be included after discussion with and approval by the sponsor*s medical monitor.
- •* Women of childbearing potential must agree to use a double barrier method of contraception throughout the study
排除标准
- •* Inability to provide informed consent
- •* Significant psychiatric disease or substance abuse
- •* History of unilateral or bilateral vagotomy
- •* History of recurrent vaso-vagal syncope episodes
- •* Known obstructive sleep apnea
- •* Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block
- •* Significant pharyngeal dysfunction or swallowing difficulties
- •* Pre-existing clinically significant vocal cord damage or hoarseness
- •* Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
- •* Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea at time of screening
- •* Active peptic ulcer disease
- •* Intra-articular or parenteral corticosteroid treatment within 3 months of enrolment
- •* Any investigational small molecule drug within 30 days of enrollment, or any investigational monoclonal antibody or investigational soluble receptor within 3 months of enrolment
研究者
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