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临床试验/NCT01142453
NCT01142453已完成不适用

Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring

Merck KGaA, Darmstadt, Germany0 个研究点目标入组 231 人开始时间: 2005年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
231
主要终点
The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period

研究概览

简要总结

This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.

详细描述

Treatment of MS, which progresses to attacks or episodes, with interferon-beta has established itself as therapy of the first choice. On the basis of different studies, the hypothesis was substantiated that the effectiveness is dependent on dose and application frequency. These realizations justify the use of high-dose interferon-beta not only in subjects in the initial stages of disease, but also in those subjects, who have a progressing disease activity even in the advanced stage, if other therapies fail. For achieving maximum benefit for the subject, an optimum therapy is imperative. The therapy plan (Immunomodulatory Therapy) of "MS Therapy Consensus Group" (MSTKG) is being widely used. In the article: "Optimising lmmunomodulatory Therapy for MS Patients" that appeared in the "International Journal of MS care" in the year 2002, a simple 9-scale model" is proposed that defines four areas respectively: not conspicuous, conspicuous, alarming and measures are necessary, in the three areas: attacks/episodes, disease progression and magnetic resonance tomography (MRT). The modification of an existing therapy, such as modifying the application plan, increasing the dosage, or substance change is recommended, if 'conspicuousness' is shown in all three areas, two areas are shown as 'alarming' or an area is shown as 'action necessary'. The decision for a therapy adjustment with the help of the "three scale model" should not happen solely on the results of the MRT. The model in the study involved attack or episode pertaining to: frequency, degree of severity, ability of involution and the response to a cortisone pulse therapy.

OBJECTIVES

  • To assess the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects
  • To identify candidates suitable for possible therapy adjustment

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes
  • •Subjects who were on one of the permitted basis therapies at least since 6 months
  • •Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.

排除标准

  • •Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications

结局指标

主要结局

The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period

时间窗: Beginning to 12 months observation period

Subject's therapy status was assessed with the help of a ready-made evaluation sheet, modified according to the so-called "Scale Model"

次要结局

未报告次要终点

研究者

申办方类型
Industry

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