What is the safety and clinical effectiveness, acceptability and cost effectiveness of flexible delivery of natalizumab (Tysabri (Registered Trademark)) by ambulatory care nurses for people with multiple sclerosis?

Dr Janakan Ravindran0 个研究点目标入组 50 人开始时间: 2016年5月12日最近更新: 2020年1月13日

试验速览

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•To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
•1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
•2.Being prescribed natalizumab
•3.have been risk assessed as safe for the flexible infusion delivery program by the prescribing Neurologist
•4.the patient has had a minimum of 6 natalizumab infusions in an infusion service unit (e.g. Royal Adelaide Hospital)
•5.JCV negative (this will be re-tested at 6 monthly intervals)
•6.comply with other vigilance requirements – MRI, bloods etc.

•Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization:
•1.Unable or unwilling to provide informed consent.
•2.MS patients 17 years or younger
•3.Have received less than 6 infusions in an infusion service unit
•4.the patient is deemed unsafe for the flexible infusion delivery program by the prescribing Neurologist.

发起方

Dr Janakan Ravindran