Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777539
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2021-02-23
Brief Title:
Comparing the Safety and Benefit of Natalizumab Tysabri At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab Tysabri Medication in Multiple Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tys at Home
Brief Summary:
At-home use of Natalizumab in multiple sclerosis MS patients has been temporarily granted by French security agency of medicines and Health products ANSM The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection Quality of life patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method
Data will be collected for a 12-month retrospective period and a 12-month prospective period
Data will be collected for a 12-month retrospective period and a 12-month prospective period
Detailed Description:
As part of the Covid-19 pandemic some neurologists have alerted the French authorities ANSM National Medicines Safety Agency to the interruption of natalizumab treatment by some MS patients The ANSM has granted temporary home use of natalizumab within the framework of a at-home hospitalization HAD program The study purpose is to assess at-home natalizumab administration regarding safety disease activity quality of life patients perception and costs by comparing outcomes before and after At Home natalizumab treatment strategy
The study consists of two periods of observation a retrospective one corresponding to the year prior the study entry and a prospective one corresponding to patient follow-up for one year from the date of the patient inclusion The date of the inclusion corresponds to the natalizumab-infusion conducted at hospital just before infusions hospital at-home started Retrospective data are collected from medical record and a minimal dataset is needed to enroll the patient regarding MRI activity and safety data ie nature and number of SAE and selected AE of grade 2 the year prior study entry
The prospective period consists of 10 at-home natalizumab infusions months 1-5 and 7-11 and 3 at-hospital natalizumab infusions inclusion months 6 and 12 according to standard care In addition to clinical MRI and safety SAE and selected AE of grade 2 data collected as part of standard medical care from medical record over all the study period Quality of life EQ-5D-5L MusiQol and patients preference Musicare questionnaires will be administered at inclusion and months 6 and 12 and clinical global impression of change will be recorded at month 6 and 12 Patients will be asked to notify any adverse events that may occur between each at-home infusion and to record each month hisher healthcare resource consumption in a diary Patients will be contacted each month after at-home infusion to record safety and healthcare resource consumption data
For a sub-group of 15 patients qualitative interview will be performed between month 3 and 8 as part of patient preference assessment
Micro-costing dedicated forms and experts statements will be used to assess resource utilization associated to natalizumab infusion during each period for medico-analyze purpose
The study consists of two periods of observation a retrospective one corresponding to the year prior the study entry and a prospective one corresponding to patient follow-up for one year from the date of the patient inclusion The date of the inclusion corresponds to the natalizumab-infusion conducted at hospital just before infusions hospital at-home started Retrospective data are collected from medical record and a minimal dataset is needed to enroll the patient regarding MRI activity and safety data ie nature and number of SAE and selected AE of grade 2 the year prior study entry
The prospective period consists of 10 at-home natalizumab infusions months 1-5 and 7-11 and 3 at-hospital natalizumab infusions inclusion months 6 and 12 according to standard care In addition to clinical MRI and safety SAE and selected AE of grade 2 data collected as part of standard medical care from medical record over all the study period Quality of life EQ-5D-5L MusiQol and patients preference Musicare questionnaires will be administered at inclusion and months 6 and 12 and clinical global impression of change will be recorded at month 6 and 12 Patients will be asked to notify any adverse events that may occur between each at-home infusion and to record each month hisher healthcare resource consumption in a diary Patients will be contacted each month after at-home infusion to record safety and healthcare resource consumption data
For a sub-group of 15 patients qualitative interview will be performed between month 3 and 8 as part of patient preference assessment
Micro-costing dedicated forms and experts statements will be used to assess resource utilization associated to natalizumab infusion during each period for medico-analyze purpose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None