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临床试验/NCT01195870
NCT01195870已完成不适用

Assessment of Patient Use of a New Device: RebiSmart

Merck KGaA, Darmstadt, Germany0 个研究点目标入组 63 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
主要终点
Percentage of subjects who liked using the RebiSmart device based on a score of 6 or more on a Visual Analogue Scale (VAS) at the end of 12-week treatment period

研究概览

简要总结

Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse.

Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times a week by injections under the skin. The RebiSmart device is a new injection device which has been developed to help patients with injecting their Rebif treatment.

Currently, all treatments for MS are injectable and require long term patient commitment. Patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. Using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. The RebiSmart device has been developed for patients to inject conveniently and in comfort. The device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on-screen injection guide. The aim of this study is to determine what percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study will also determine which of the device features were most useful to the patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have relapsing remitting multiple sclerosis
  • Between 18 to 65 years old inclusive
  • Have been prescribed Rebif for the first time but not yet started treatment
  • Rebismart as chosen device
  • Be under review by MS nurse
  • Having given written informed consent to participate in the study

排除标准

  • Injections of Rebif given by someone other than the patient
  • Patients unable to use the Rebismart device due to visual or physical impairment
  • Patients unwilling to give informed consent
  • Contra-indications to Rebif as defined in the Summary of Product Characteristics (SPC).
  • Allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms

结局指标

主要结局

Percentage of subjects who liked using the RebiSmart device based on a score of 6 or more on a Visual Analogue Scale (VAS) at the end of 12-week treatment period

时间窗: up to week 16

次要结局

  • Percentage of patients who found RebiSmart easy or very easy to use at the end of 12-week treatment period(up to week 16)
  • Top three functions of the device patients found most useful; top ranked from 1 to 10(up to week 16)

研究者

申办方类型
Industry
责任方
Sponsor

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