NCT00219908终止2 期
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b
Rennes University Hospital46 个研究点 分布在 2 个国家目标入组 124 人开始时间: 1999年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 124
- 试验地点
- 46
- 主要终点
- Time to confirmed progression of at least one EDSS point during the 3 years of the study.
研究概览
简要总结
The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 接受健康志愿者
- 否
入选标准
- •age : 18-45 years,
- •Clinical disease satisfying the Poser criteria (Amdmt n°4)
- •relapsing-remitting disease (Amdmt N°4)
- •at least 2 exacerbations within the preceding 12 months, having left sequelae,
- •MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
- •a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
- •written informed consent
排除标准
- •pregnancy and breast-feeding
- •use of an insufficiency effective contraceptive method,
- •general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
- •treatment with azathioprine during the 3 months preceding the study
- •clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
- •associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
结局指标
主要结局
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
次要结局
- - percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study,
- - annual rate of relapse;
- - percentage of relapse-free patients during the study period,
- - quality of life,
- - percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden).
研究者
研究点 (46)
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