A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,064
- 试验地点
- 1
- 主要终点
- Confirmed Annualized Relapse Rate
研究概览
简要总结
The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
详细描述
This was a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS.
This study consisted of 3 periods:
- Screening Period: up to 45 days for all patients
- Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
- Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).
Treatment groups:
- fingolimod 0.5 mg/day orally for up to 12 months
- fingolimod 0.25 mg/day orally for up to 12 months
- glatiramer acetate 20 mg/day subcutaneously for up to 12 months
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, Outcomes Assessor)
盲法说明
Fingolimod patients were dose blind.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
fingolimod 0.5 mg
orally once daily
干预措施: fingolimod (Drug)
fingolimod 0.25mg
orally once daily
干预措施: fingolimod (Drug)
glatiramer acetate 20 mg
subcutaneous once daily
干预措施: glatiramer acetate (Drug)
结局指标
主要结局
Confirmed Annualized Relapse Rate
时间窗: up to 12 months
Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.
次要结局
- Change From Baseline in T2 Lesion Volume(Baseline, 12 months/end of study)
- Percentage of Patients Free of New T1 Hypointense Lesions(12 months)
- New or Newly Enlarging T2 Lesions(At 12 months/end of study)
- Gd Enhancing T1 Lesion Volume(Baseline, 12 months/end of study)
- Gd Enhancing T1 Lesion Count(At 12 months/end of study)
- Number of Participants Free of New/Newly Enlarged T2 Lesions(At 12 months/end of study)
- Change From Baseline in TSQM Scales(6 months, 12 months/end of study)
- Percent Brain Volume Change From Baseline(Baseline, 12 months, end of study)