Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change (EPOC)
2015年6月18日 更新者：Novartis Pharmaceuticals
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 Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)
The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
研究概览
研究类型
介入性
注册 (实际的)
61
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Novara、意大利、28100
- Novartis Investigative Site
-
-
AN
-
Ancona、AN、意大利、60126
- Novartis Investigative Site
-
-
BI
-
Ponderano、BI、意大利、13900
- Novartis Investigative Site
-
-
CL
-
Caltanissetta、CL、意大利、93100
- Novartis Investigative Site
-
-
CN
-
Cuneo、CN、意大利、12100
- Novartis Investigative Site
-
-
CO
-
Como、CO、意大利、22100
- Novartis Investigative Site
-
-
CT
-
Catania、CT、意大利、95122
- Novartis Investigative Site
-
-
FG
-
Foggia、FG、意大利、71100
- Novartis Investigative Site
-
-
FI
-
Castelfiorentino、FI、意大利、50051
- Novartis Investigative Site
-
-
MI
-
Milano、MI、意大利、20133
- Novartis Investigative Site
-
Milano、MI、意大利、20122
- Novartis Investigative Site
-
San Donato Milanese、MI、意大利、20097
- Novartis Investigative Site
-
-
MO
-
Modena、MO、意大利、41100
- Novartis Investigative Site
-
-
PA
-
Palermo、PA、意大利、90146
- Novartis Investigative Site
-
Palermo、PA、意大利、90129
- Novartis Investigative Site
-
-
PI
-
Pisa、PI、意大利、56126
- Novartis Investigative Site
-
-
VR
-
Legnago、VR、意大利、37045
- Novartis Investigative Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
- Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
- Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
- Naïve to treatment with fingolimod.
Exclusion Criteria:
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
- Diagnosis of macular edema during Screening Phase.
Other protocol-defined inclusion/exclusion criteria may apply
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
|
0.5 毫克/天口服胶囊
其他名称：
|
|
有源比较器：Multiple Sclerosis Disease Modifying Treatment (MS DMT)
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.
|
Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Patient-reported Treatment Satisfaction
大体时间：baseline, 6 months
|
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication.
It consists of 3 subscales: effectiveness, convenience and global satisfaction.
The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction.
The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range.
The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction.
This provided a transformed score between 0 and 1 that was then multiplied by 100.
A positive change from baseline indicates improvement.
|
baseline, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Patient-reported Activities of Daily Living (ADL)
大体时间：baseline, 6 months
|
The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living.
The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation.
A negative change from baseline indicates improvement.
|
baseline, 6 months
|
|
Change From Baseline in Patient-reported Fatigue
大体时间：6 months
|
The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue.
The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)).
A negative change from baseline indicates improvement.
|
6 months
|
|
Change From Baseline in Patient-Reported Effectiveness and Convenience
大体时间：6 months
|
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication.
It consists of 3 subscales: effectiveness, convenience and global satisfaction.
The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction.
The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range.
The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction.
This provided a transformed score between 0 and 1 that was then multiplied by 100.
A positive change from baseline indicates improvement.
|
6 months
|
|
Change From Baseline in Patient-reported Depression
大体时间：6 months
|
The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness.
The BDI-FS score was calculated summing the 7 items of the questionnaire.
Each item ranged from 0 (not present) to 3 (severe).
The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression).
A negative change from baseline indicates improvement.
|
6 months
|
|
Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
大体时间：6 months
|
The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS.
It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
If half or more questions within a domain were answered, then a score was calculated for that domain.
Otherwise, the patient score for that domain was set to missing.
If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing.
An algorithm was used to create a score from 0 to 100 for each domain score and component score.
A positive change from baseline indicates improvement.
|
6 months
|
|
Physician-reported Clinical Global Impression of Improvement (CGI-I)
大体时间：6 months
|
The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time.
The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse.
A lower score and a negative change from baseline indicate improvement.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Renato Turrini, MD、Novartis Farma S.p.A.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2011年3月15日
首先提交符合 QC 标准的
2011年3月15日
首次发布 (估计)
2011年3月16日
研究记录更新
最后更新发布 (估计)
2015年6月22日
上次提交的符合 QC 标准的更新
2015年6月18日
最后验证
2015年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.