Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03806387
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2019-01-09
Brief Title:
Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
Multiple Sclerosis MS is a chronic autoimmune neurodegenerative disease of the central nervous system CNS The symptoms of MS are wide-ranging but patients perceive loss of physical function gait and cognitive function as the most critical consequences of the disease Moreover recent studies have shown that already at early disease stages functional impairments are present
One of the more recent approved medical treatments for MS patients is Alemtuzumab product name Lemtrada a humanized monoclonal antibody targeting CD52 cells that depletes and repopulates B lymphocytes and T lymphocytes causing sustained changes in the adaptive immunity In 2013 and 2014 Alemtuzumab was approved in EU and USA respectively
With the exception of the MS Functional Composite z-score the previous clinical studies investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such as MRI indications of disease activity accumulation of lesion total and regional brain atrophy etc relapse-rates changes in expanded disability status scale EDSS and side-effectsadverse events However no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with Alemtuzumab despite the paramount importance to patients
The primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of people with relapsing-remitting MS A secondary purpose is to monitor the impact of Alemtuzumab treatment on cognition during the first two years of treatment
One of the more recent approved medical treatments for MS patients is Alemtuzumab product name Lemtrada a humanized monoclonal antibody targeting CD52 cells that depletes and repopulates B lymphocytes and T lymphocytes causing sustained changes in the adaptive immunity In 2013 and 2014 Alemtuzumab was approved in EU and USA respectively
With the exception of the MS Functional Composite z-score the previous clinical studies investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such as MRI indications of disease activity accumulation of lesion total and regional brain atrophy etc relapse-rates changes in expanded disability status scale EDSS and side-effectsadverse events However no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with Alemtuzumab despite the paramount importance to patients
The primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of people with relapsing-remitting MS A secondary purpose is to monitor the impact of Alemtuzumab treatment on cognition during the first two years of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None