High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab

Biogen Idec0 个研究点目标入组 20 人开始时间: 2010年8月18日最近更新: 2012年3月19日

适应症

试验速览

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•1. The subject or his/her legally authorized representative must understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
•2. Age 18 years or older at the time of informed consent.
•3. Subjects of childbearing potential must practice effective contraception during the study.
•4. Must have been receiving natalizumab for multiple sclerosis prior to the diagnosis or suspicion of PML.
•5. Subject must be willing to undergo or have completed PLEX (or equivalent) prior to initiating study treatment.
•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

•1. History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.
•2. Female subjects who are pregnant or currently breastfeeding or are considering becoming pregnant while in the study.
•3. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
•4. Any other condition, clinical finding, or reason that, in the opinion of the Investigator and/or the Sponsor, is determined to be unsuitable for enrollment into this study.

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