ISRCTN16202527已完成不适用
ordic trial of methylprednisolone as add-on therapy to interferon-beta for the treatment of relapsing-remitting multiple sclerosis: a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial
Danish Multiple Sclerosis Research Center (Denmark)0 个研究点目标入组 300 人开始时间: 2009年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females between the age of 18 and 55 years (both included)
- •2. Has multiple sclerosis according to the McDonald criteria and suffers from clinically definite relapsing-remitting MS according to the Poser criteria
- •3. Has a disability equivalent to Expanded Disability Status Scale (EDSS) of 5.5 or less
- •4. Has been on treatment with IFN-beta-1a (Rebif®) for at least 1 year and has received IFN-beta-1a (Rebif®) 44 µg three times weekly for at least 1 month
- •5. Has shown clinical activity defined as at least one relapse during the previous 12 months and thereby is classified as a patient with partial treatment response. A historical relapse may be accepted as qualifying as judged by the treating physician.
- •6. Is prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits
- •7. Female of childbearing potential must use adequate contraceptive methods and must have negative pregnancy test results
- •8. Has given written informed consent
排除标准
- •1. Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide, or long-term systemic glucocorticoids
- •2. Has received treatment with azathioprine, cyclosporine, glatiramer acetate, or other immunosuppressive agents or intravenous immunoglobulin within 6 months prior to inclusion in the study
- •3. Has changed IFN-beta preparation or dose within 3 months of inclusion in the study
- •4. Has received treatment with systemic glucocorticoids (relapse treatment) or adrenocorticotropic hormone (ACTH) within 8 weeks prior to inclusion in the study
- •5. Has experienced a relapse within one month prior to the inclusion in the study
- •6. Has converted to secondary progressive MS
- •7. Has a history of peptic ulcer or present symptoms of dyspepsia
- •8. Has suffered from major depression or any other psychiatric disorder that would preclude safe participation in the study
- •9. Has diabetes mellitus
- •10. Has alcohol or drug abuse
- •11. Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischaemic heart disease (New York Heart Association [NYHA] Functional Classification III or IV), or malignant hypertension
- •12. Has renal insufficiency
- •13. Has aspartate aminotransferase (ASAT) greater than 2.5 x normal upper limit
- •14. Has leucopenia less than 2500 leucocytes per microlitre or thrombocytopenia less than 100,000 thrombocytes per microlitre
- •15. Has any medical illness requiring treatment with systemic corticosteroids
- •16. Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability
- •17. Has formerly shown severe reactions against corticosteroids
- •18. Is pregnant or breast-feeding
- •19. Has epilepsy not under control by anti-epileptic drug (AED)
研究者
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