NCT01498887已完成4 期
A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Annual Relapse Rate (ARR)
研究概览
简要总结
This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
- •Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.
- •Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
- •Previously treated with a first-line Disease Modifying Therapy
排除标准
- •Patients who have received treatment with:
- •Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Naive or de novo participants
Experimental
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
干预措施: Fingolimod (FTY720) (Drug)
Previously treated with first-line DMTs participants
Experimental
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
干预措施: Fingolimod (FTY720) (Drug)
结局指标
主要结局
Annual Relapse Rate (ARR)
时间窗: 12 months
ARR = 365 days \* number of relapses / total days taking the study medication.
次要结局
- Time to First Relapse(first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months)
- Change From Baseline in Expanded Disability Status Scale (EDSS) Score(baseline, 12 months)
- Change From Baseline in Cerebral Volume(baseline, 12 months)
- Percentage of Participants With Mild, Moderate or Severe Relapse(12 months)
- Percentage of Relapse-free Participants(12 months)
- Mean Number of T2 Active Lesions(12 months)
研究者
研究点 (1)
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