An observational study in Multiple Sclerosis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by University of Aarhus · Observational
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-effects/adverse 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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 17 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Multiple Sclerosis patients will be recruited from MS clinics all over Denmark.
Exclusion Criteria:
Alemtuzumab will be given two times, separated by 1 year.
Also known as: Lemtrada
Six minute walking test (6MWT)
Change in maximal walking distance covered in 6 minutes
Time frame: From baseline to 24 months
Six minute walking test (6MWT)
Change in maximal walking distance covered in 6 minutes
Time frame: From baseline to 3 months, 6 months, and 12 months
Timed 25 foot walk (T25FWT)
Change in maximal walking speed
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
5 times sit to stand test (5STS)
Change in time to perform 5 times sit to stand test (5STS)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Timed Up and Go (TUG)
Change in time to perform Timed Up and Go (TUG)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Stair Climbing test
Change in time to perform 9-step stair climbing
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Six Spot Step Test (SSST)
Change in maximal walking speed while challenging coordination/balance
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Maximal oxygen uptake (VO2 max)
Change in aerobic power
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Maximal muscle strength
Change in isometric and dynamic knee extensor muscle strength, isometric hand grip strength
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Neuromuscular activation
Change in neural drive during maximal isometric knee extension
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Body composition - limb lean mass
Change in total lower limb lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Body composition - limb fat mass
Change in total lower limb fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Body composition - whole body lean mass
Change in total body lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Body composition - whole body fat mass
Change in total body fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Selective Reminding Test (SRT)
Change in cognitive test assessing memory
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Symbol Digit Modalities Test (SDMT)
Change in cognitive test assessing processing speed
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Physical activity
Change in accelerometer-based assessment of 24-hour physical activity
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Clinical Severity of Disease
Estimation of disease severity by the Expanded Disability Severity Scale (EDSS scores: best 0 = normal neurological exam, worst 10 = death due to multiple sclerosis)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Relapse frequency
Number of relapses
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
12-item Multiple Sclerosis Walking Scale (MSWS-12)
Self-reported questionnaire assessing impact of MS on walking ability (MSWS-12 scores: best 0, worst 100)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Modified Fatigue Impact Scale (MFIS)
Self-reported questionnaire assessing impact of MS-induced fatigue on a persons life (MFIS total scores: best 0, worst 84; physical subscale scores: best 0, worst 36; cognitive subscale scores: best 0, worst 40; psychosocial subscale scores: best 0, worst 8)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Multiple Sclerosis Impact Scale (MSIS-29)
Self-reported questionnaire assessing impact of MS on day-to-day life, from a physical perspective (MSIS-29 physical scale: best 0, worst 100 (greater impact of disease on daily function = worse health) and from a psychological perspective (MSIS-29 psychological scale: best 0, worst 100 (greater impact of disease on daily function = worse health)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
Hospital Anxiety and Depression Scale (HADS)
Self-reported questionnaire assessing impact of MS on anxiety (scores: best 0, worst 21) and depression (scores: best 0, worst 21)
Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Aarhus