EUCTR2005-001026-89-DE进行中（未招募）不适用
Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)
Serono GmbH0 个研究点目标入组 100 人开始时间: 2005年5月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Definite RRMS or SPMS with relapses
- •- EDSS 1-6
- •- Escalation to mitoxantrone due to relapse activity or MRI activity during last year prior to mitoxantrone or EDSS progression combined with relapse activity or MRI activity during last year prior to mitoxantrone (not due to EDSS progression exclusively)
- •- Last mitoxantrone treatment between >= 1 and <= 6 months
- •- Mitoxantrone for min. 9, max. 36 months, total cumulative dose 40-120 mg/m2 body surface area
- •- Subject may not have a confirmed 1point EDSS progression (0.5 points for EDSS > 5.5) within the last 9 months
- •- Subject should be free of relapses over the last 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subject received any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1 (SD1, week 0)
- •- Subject was escalated to mitoxantrone due to EDSS progression only (without any relapse or MRI activity during the last year prior to mitoxantrone
- •- Subject has Primary Progressive MS
- •- Subject has Secondary Progressive MS without superimposed relapses
- •- Subject received immunmodulatory treatment other than IFN-beta, glatirameracetat, azatriopine, immunglobulins, or no treatment before mitoxantrone
- •- Subject has previously received total lymphoid irradiation
- •- Subject received oral or systemic corticosteroids or ACTH within 30 days of SD1
- •- Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1
- •- Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, teriflunomide, laquinimod, Campath) within the 12 months prior to SD1
- •- Subject requires chronic or monthly pulse corticosteroids during the study
- •- Subject received any investigational drug or experimental procedure within 12 month of SD1 (Week 0) or is currently participating in another clinical trial
- •- Subject suffers from major medical or psychiatric illness (e.g. severe depression and/or suicide risk) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- •- Known clinically significant cardiac or other systemic diseases
- •- Previous treatment with natalizumab
- •- Subject suffers from epilepsy without adeqaute therapeutic control of attacks
- •- Subject has inadequate bone marrow reserve, defined as a white blood cell count
- •less than 0.5 times the lower limit of normal and platelet count <100x103/µl.
- •- Subject suffers from the following concurrent autoimmune diseases: SLE, ITP, Rheumatoid arthritis, Crohn´s Disease, Diabetes mellitus.
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