An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions
研究概览
简要总结
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
详细描述
A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.
The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT
- •Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.
排除标准
- •Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Fingolimod 0.5 mg
Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
干预措施: Fingolimod (Drug)
Fingolimod 1.25 mg
Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
干预措施: Fingolimod (Drug)
Placebo-fingolimod
Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
干预措施: Fingolimod (Drug)
结局指标
主要结局
Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions
时间窗: Months 6, 9, 12, 18, 24, 36, and 48
To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.
次要结局
- Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions(Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years))
- Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses(Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years))
- Percentage of Patients Relapse-free at the End of the Study(Baseline to the end of the study (up to 4 years))
- Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment(Baseline to the end of the study (up to 4 years))
- Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score(Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years))