A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Merck KGaA0 个研究点目标入组 445 人开始时间: 2018年2月6日最近更新: 2019年6月30日

研究概览

暂无简介。

•Male or female subjects = 18 years old;
•Highly active RMS as defined by:
•- One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs);
•- Two or more relapses in the previous year, whether on DMD treatment or not;
•EDSS score =5.0
•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 445
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Positive test for hepatitis C or positive tests for hepatitis B infection:
•either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti-HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
•Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
•Currently receiving immunosuppressive or myelosuppressive therapy with, (e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine, mitoxantrone or azathioprine), or chronic use of corticosteroids.
•History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
•Presence of signs of progressive multifocal leukoencephalopathy
•(PML) detected by MRI, clinical and/or biomarker evaluations or other (than MS) major Central Nervous System disease clinically diagnosed or evidenced in screening MRI
•Active malignancy and history of malignancy
•Hypersensitivity to Mavenclad® or to any of the excipients listed in the SmPC
•Presence or suspect of PML or other (than MS) major Central Nervous System disease clinically diagnosed or evidences in screening MRI
•Moderate or severe renal impairment (creatinine clearance <60 mL/min)

发起方