A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis

ovartis Pharma Services AG0 个研究点目标入组 96 人开始时间: 2014年4月9日最近更新: 2018年11月12日

试验速览

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•-Male and female patients 18 to 55 years of age.
•-Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman, et. al. 2011).
•-A relapsing-remitting course of disease with:
•at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization as per criterion 6), or a positive Gd-enhancing lesion on brain MRI scan at screening.
•-An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
•-No evidence of a relapse within 30 days prior to randomization.
•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 96
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-A manifestation of another type of MS other than RRMS.
•-Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.
•-History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome.
•-Unable to undergo MRI scans due to inter-alia, claustrophobia, incompatible cardiac pacemakers, ferromagnetic intracranial, Aneurysm clips, certain cochlear implants, and certain other ferromagnetic foreign bodies (e.g. tattoos containing metal) or electronic devices, or metallic implants incompatible with MRI.
•-Unable to receive gadolinium-based MRI contrast agents due to a history of hypersensitivity to gadolinium-based contrast agents, renal insufficiency or impairment.
•-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the course of the study and for 4 months following completion of the study.
•-Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects lasting longer than 6 months (wash-out times for other registered or putative immunomodulators or immunosupressants apply)

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