EUCTR2008-004954-34-BE进行中（未招募）1 期
Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIO
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany0 个研究点目标入组 492 人开始时间: 2009年1月23日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 492
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
- •All of the following criteria must be met for inclusion of a subject into the trial:
- •· Reach scheduled End of Study in study 27025 (completion of 24 months participation),
- •· Medical assessment by the Investigator/treating physician from study 27025 that there is no objection to the subject’s participation in this extension trial considering the medical experience from study 27025. Special attention should be given to laboratory abnormalities and clinically significant liver, renal and bone-marrow dysfunction,
- •· If female, subject must:
- •· be neither pregnant nor breast-feeding, nor attempting to conceive,
- •· use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner,
- •· Subject is willing to follow study procedures,
- •· Subject has given written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 492
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects are to be excluded from enrolment into the trial if they fulfill any of the following exclusion criteria:
- •· Subject has any disease other than MS that could better explain the subject’s signs and symptoms,
- •· Subject has a primary progressive course of MS,
- •· Subject has total bilirubin > 2.5 times upper limit of normal at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation of the value),
- •· Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of normal values at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation of the value),
- •· Subject suffers from another current autoimmune disease,
- •· Subject suffers from major medical or psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol,
- •· Subject has a history of seizures not adequately controlled by treatment,
- •· Subject has cardiac disease, such as angina, congestive heart failure or arrhythmia,
- •· Subject has a known allergy to IFN-beta or the excipient(s) of the study medication,
- •· Subject has any condition that could interfere with the MRI evaluation,
- •· Subject has a known allergy to gadolinium-DTPA,
- •· Subject has a history of alcohol or drug abuse,
- •· Subject has previously participated in this study,
- •· Subject has moderate to severe renal impairment,
- •· Subject is pregnant or lactating,
- •· Subject has any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol, or to complete the study.
研究者
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