A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6
研究概览
简要总结
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing forms of MS
- •Expanded Disability Status Scale (EDSS) 0-5.5
- •Continuous treatment with MS DMT for a minimum of 6 months
- •Fingolimod naive
排除标准
- •Immune system diseases other than MS
- •Active macular edema
- •History of selected prior infections and criteria for immunizations
- •History of selected immune system treatments and/or medications
- •Selected cardiovascular, pulmonary, or hepatic conditions
- •Selected abnormal laboratory values
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria applied
研究组 & 干预措施
Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .
干预措施: Fingolimod (Drug)
Multiple Sclerosis Disease Modifying Treatments (MS DMTs)
Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
干预措施: Standard MS DMTs (Drug)
结局指标
主要结局
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6
时间窗: Baseline, Month 6
The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.
次要结局
- Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4(Baseline, Month 6)
- Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)(Baseline, Month 6)
- Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)(Baseline, Month 3, Month 6)
- Physician-reported Clinical Global Impression of Improvement (CGI-I)(Month 3, Month 6)
- Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death(9 months (6 month core + 3 month Extension))
- Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6(Baseline, Month 6)
- Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)(Baseline, Month 3, Month 6)
- Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4(Baseline, Month 6)
- Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4(Baseline, Month 6)