None listed
Conditions
Brief summary
In some countries (eg Canada and UK), some patients can receive monoclonal antibody (MAB) treatment at home, under the supervision of an appropriately trained registered nurse. However, we are not aware of any comparable studies examining the safety of natalizumab and flexible delivery (i.e. treatment at home, or in a community setting) for people with multiple sclerosis (MS). Therefore, the broad objective of this study is to investigate the flexible delivery of natalizumab. In many cases, it is anticipated that flexible delivery will entail delivery in the patient’s own home. The study will compare the flexible delivery of natalizumab with usual care (attendance in an outpatient department) and answer whether it is acceptable to patients, is effective and safe, and is cost effective. The study will comprise a pilot study to better understand feasibility and safety, and to inform a larger, proposed full-scale study. The primary objective of the study is to determine whether the flexible delivery of natalizumab is safe for people with MS. The additional objectives of this study in this study population are as follows: (a) Is the flexible delivery of natalizumab acceptable to patients and healthcare staff? (b) Is the flexible delivery of natalizumab as effective in treating symptoms? (c) Is the flexible delivery of natalizumab cost effective?
Interventions
Subjects in the treatment group will receive three 300mg natalizumab infusions occurring once every 4 weeks flexibly (either at home or in a workplace) from a Tysabri Australasian Prescribing Program (TAPP) trained ambulatory care nurse (level 3 RN). After three infusions in Phase 1 (lasting three months), subjects will cross over to the control group in Phase 2 and receive usual care for another three infusions (lasting three months). Crossover will therefore occur between the third and fourth
Subjects in the treatment group will receive three 300mg natalizumab infusions occurring once every 4 weeks flexibly (either at home or in a workplace) from a Tysabri Australasian Prescribing Program (TAPP) trained ambulatory care nurse (level 3 RN). After three infusions in Phase 1 (lasting three months), subjects will cross over to the control group in Phase 2 and receive usual care for another three infusions (lasting three months). Crossover will therefore occur between the third and fourth infusions.
Sponsors
Dr Janakan Ravindran
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed