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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change From Baseline in Patient-reported Treatment Satisfaction
研究概览
简要总结
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
- •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.
排除标准
- •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
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 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.
干预措施: Standard MS DMT (Drug)
结局指标
主要结局
Change From Baseline in Patient-reported Treatment Satisfaction
时间窗: 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.
次要结局
- Change From Baseline in Patient-reported Activities of Daily Living (ADL)(baseline, 6 months)
- Change From Baseline in Patient-Reported Effectiveness and Convenience(6 months)
- Change From Baseline in Patient-reported Depression(6 months)
- Physician-reported Clinical Global Impression of Improvement (CGI-I)(6 months)
- Change From Baseline in Patient-reported Fatigue(6 months)
- Change From Baseline in Patient-reported Health Related Quality of Life (QOL)(6 months)