Multicenter interventional Phase IV study for the assessment of the effects on patient’s satisfaction of Plegridy (pre-filled pen) in subjects with relapsing-remitting multiple sclerosis unsatisfied with other injectable subcutaneous Interferons. PLATINUM STUDY - PLATINUM

BIOGEN IDEC ITALIA S.R.L.0 个研究点目标入组 275 人开始时间: 2016年9月28日最近更新: 2019年1月7日

试验速览

暂无简介。

•18 < Age < 65 years
•RRMS as per 2010 McDonald criteria
•Baseline EDSS between 0.0 and 5.0
•Treatment with injectable subcutaneous Interferons with score < 58 in the convenience satisfaction” domain of TSQM-9
•Signed informed consent
•Period of stability from last relapse of at least 30 days before the baseline visit.
•Treatment with intravenous corticosteroids completed at least 30 days before the baseline visit (assumption of oral cortisone allowed as long as within 4 mg per day for no longer than 3 days).
•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 275
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnancy or breast-feeding
•Depression or other psychiatric disorders
•Unwillingness or inability to comply with the protocol requirements
•Any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics

发起方

BIOGEN IDEC ITALIA S.R.L.