EUCTR2006-005972-42-FR进行中（未招募）1 期
A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Subject with Relapsing Forms of MS (RMS)
- •EDSS score <- (equal or less than) 5.5 at study entry
- •Subjects who have been administering Rebif 44mcg tiw for at least 6 months prior to study enrolment·
- •Subject currently using Rebiject II and who will use own Rebiject II for the RNF injections
- •Subject is between 18 and 60 years old inclusive
- •Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either: Post-menopausal or surgically sterile, or Using a highly effective method of contraception. A highly effective method of contraception is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs (intrauterine devices), sexual abstinence or vasectomised partner.
- •Subject is willing to follow study procedures
- •Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks
- •Subject has given written informed consent.
- •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
- •Secondary Progressive Multiple Sclerosis (SPMS) without superimposed attacks
- •Use of any other injectible medications during the week prior to the screening period, during the screening or treatment periods
- •Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3 months prior to study enrolment or at any time during study protocol·
- •History of any chronic pain syndrome
- •Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1
- •Subject received corticosteroids or ACTH within 30 days of visit 1
- •Subject with flu-like symptoms associated with any cause (i.e. no current flu and no FLS related to Interferon in the week prior to baseline)
- •Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values
- •Subject has inadequate bone marrow reserve, defined as a total white blood cell count < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.
- •Subject suffers from an active autoimmune disease other than MS.
- •Subject suffers from major medical or psychiatric illness (including current, severe disorders and/or suicidal ideation) that in the opinion of the investigator could affect compliance with the study protocol
- •Subject is pregnant or attempting to conceive
- •Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself
- •Contraindication to ibuprofen.
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