A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Change in Patient-reported Treatment Satisfaction
研究概览
简要总结
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
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
- •Written informed consent must be obtained before any assessment is performed.
- •Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
- •Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- •Male or female patients aged 18-70 years.
- •An Expanded Disability Status Scale (EDSS) score of 0-6 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.
- •Diagnosis of macular edema during Screening Phase.
- •Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
- •Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
- •Patients who have received total lymphoid irradiation or bone marrow transplantation.
- •History of selected immune system treatments and/or medications.
- •Any medically unstable condition, as assessed by the investigator.
- •Selected cardiovascular, or hepatic conditions
- •Selected abnormal laboratory values.
- •Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
- •Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
- •History of hypersensitivity to the study drug or to drugs of similar chemical classes.
- •Pregnant or nursing (lactating) women.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fingolimod
Participants received 0.5 mg orally once a day.
干预措施: Fingolimod (Drug)
Standard Disease Modifying Therapy (DMT)
Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
干预措施: Interferon beta - 1a (IFN) (Drug)
Standard Disease Modifying Therapy (DMT)
Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
干预措施: Glatiramer acetate (GA) (Drug)
结局指标
主要结局
Change in Patient-reported Treatment Satisfaction
时间窗: Baseline, 6 months
The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
次要结局
- Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death(6 months)
- Changes in Patient-reported Effectiveness, Side Effects and Convenience(Baseline, 6 months)
- Change in Patient-reported Depression(Baseline, 6 months)
- Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)(Baseline, 6 months)