Multicenter, open-label, 12 weeks,phaseIV pRospectivE randomized study aimed at evaLuating whether sc IFN beta 1a(Rebif®) administered In the morning may affEct the severity of Flu-like syndromeand patient perceived invisible symptoms in subjects with relapsing multiple sclerosis - RELIEF

Merck Serono S.p.A.0 个研究点目标入组 200 人开始时间: 2013年12月12日最近更新: 2022年4月4日

试验速览

暂无简介。

•1.Males and females between 18 and 60 years of age;
•2.Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study;
•3.Patients have relapsing multiple sclerosis (RMS) according to the revised McDonald Criteria (2010);
•4.Patients with an expanded disability status scale (EDSS) score < 6.0;
•5.Patients naïve to treatment and eligible for treatment with Rebif® 44 tiw, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months;
•6.Patients able to self-inject treatment using RebiSmart™;
•7.Patients willing and able to comply with the protocol for the duration of the study;
•8.Patients have given written informed consent to take part in the study.
•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 218
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Patients have any disease other than MS that could better explain their signs and symptoms;
•2.Patients received any immunosuppressive agents within 3 months prior to Baseline;
•3.Patients received any corticosteroids within 30 days prior to baseline;
•4.Patients have a MS relapse within 30 days prior to Baseline;
•5.Patients 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;
•6.Patients have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal (LLN);
•7.Patients have moderate to severe renal impairment;
•8.Patients have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart™;
•9.Patients have hypersensitivity to natural or recombinant interferon, or to any of its excipients;
•10.Patients have any contra-indications to treatment with IFN-beta 1a according to Summary of Product Characteristics (SmPC);
•11.Patients have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC;
•12.Obese patients, defined by BMI >30 kg/m2;
•13.Patients have participated in any other investigational trial within 30 days from Baseline;
•14.Patients have any other significant disease that in the Investigator’s opinion would exclude the subject from the trial.

发起方

Merck Serono S.p.A.