Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
研究概览
简要总结
This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.
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
- Double (Participant, Investigator)
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
- •Diagnosis of relapsing multiple Sclerosis (MS)
- •Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
- •Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
- •Extension Study
- •A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
- •Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
- •Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
排除标准
- •Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
- •Pregnant or nursing women
- •Extension Study
- •Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
- •Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fingolimod (FTY720) 1.25 mg/day
Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
干预措施: FTY720 (Drug)
Placebo/Fingolimod (FTY720)
Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
干预措施: Placebo (Drug)
Fingolimod (FTY720) 5.0 mg/day
Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
干预措施: FTY720 (Drug)
结局指标
主要结局
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
时间窗: Month 6 (Core)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12
时间窗: Month 12 (extension)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60
时间窗: Month 60 (extension)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study
时间窗: Last observation (Up to 80 months in average)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
次要结局
- Percentage of Participants Free of T1-weighted Lesions(Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average))
- Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit(Month 6 and 12, 60, last observation (up to 80 months in average))
- Mean Number of New T2-weighted Lesions((Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average))
- Volume of T2-weighted Lesions((Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average))
- Change From Baseline in Volume of Total T2-weighted Lesions(Baseline to month 6, 12, 60 and Last observation (up to 80 months in average))
- Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients(Month 6,12,60 and Last observation (up to 80 months in average))
- Mean Trough Blood Concentrations of FTY720(Month 3 and 6)