EUCTR2009-013333-24-IT进行中（未招募）不适用
Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGE
相关药物
试验速览
- 阶段
- 不适用
- 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
- •? Males and females between 18 and 65 years of age ? Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential ? Have RMS according to the revised McDonald Criteria (2005) ? Eligible for treatment with RNF (44mcg) ? Subjects switching from another injectable disease modifying drug (DMD) ? Able to self-inject treatment using RebiSmart ? Willing and able to comply with the protocol for the duration of the study ? Have 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Have any disease other than MS that could better explain his/her signs and symptoms ? Have received any immunosuppressive agents within 3 months prior to Baseline ? Have a relapse within 30 days prior to Baseline ? Have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase ? Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal (LLN) ? Have moderate to severe renal impairment ? Have serious or acute heart disease such as uncontrolled cardiac dysarhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure ? Have a history of severe depression or suicide attempt, or current suicidal ideation ? Have epilepsy not adequately controlled by treatment ? Current or past (within last 2 years) alcohol or drug abuse ? Any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart ? Have any contra-indications to treatment with IFN-beta 1a according to Summary of Product Characteristics ? Have any contra-indications to treatment with ibuprofen according to Summary of Product Characteristics ? Have participated in any other investigational trial within 30 days from Baseline ? Have any other significant disease that in the Investigator?s opinion would exclude the subject from the trial
研究者
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