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Completed

NCT Number: NCT03806387

Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University, Health, Section for Sport Science

Aarhus, Jutland, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical definite Multiple Sclerosis diagnosis according to the McDonald criteria
  • About to commence alemtuzumab (Lemtrada) treatment
  • Expanded Disability Status Scale (EDSS) ≤ 5.5
  • Signed informed consent

Exclusion criteria

  • Co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)

Treatment and study plan

Alemtuzumab

Drug

Alemtuzumab will be given two times, separated by 1 year.

Other names: Lemtrada

Primary outcomes

  1. Six minute walking test (6MWT)

    Time frame: From baseline to 24 months

    Change in maximal walking distance covered in 6 minutes

Secondary outcomes

  1. Six minute walking test (6MWT)

    Time frame: From baseline to 3 months, 6 months, and 12 months

    Change in maximal walking distance covered in 6 minutes

  2. Timed 25 foot walk (T25FWT)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in maximal walking speed

  3. 5 times sit to stand test (5STS)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in time to perform 5 times sit to stand test (5STS)

  4. Timed Up and Go (TUG)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in time to perform Timed Up and Go (TUG)

  5. Stair Climbing test

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in time to perform 9-step stair climbing

  6. Six Spot Step Test (SSST)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in maximal walking speed while challenging coordination/balance

  7. Maximal oxygen uptake (VO2 max)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in aerobic power

  8. Maximal muscle strength

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in isometric and dynamic knee extensor muscle strength, isometric hand grip strength

  9. Neuromuscular activation

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in neural drive during maximal isometric knee extension

  10. Body composition - limb lean mass

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in total lower limb lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

  11. Body composition - limb fat mass

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in total lower limb fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

  12. Body composition - whole body lean mass

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in total body lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

  13. Body composition - whole body fat mass

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in total body fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

  14. Selective Reminding Test (SRT)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in cognitive test assessing memory

  15. Symbol Digit Modalities Test (SDMT)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in cognitive test assessing processing speed

  16. Physical activity

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Change in accelerometer-based assessment of 24-hour physical activity

  17. Clinical Severity of Disease

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Estimation of disease severity by the Expanded Disability Severity Scale (EDSS scores: best 0 = normal neurological exam, worst 10 = death due to multiple sclerosis)

  18. Relapse frequency

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Number of relapses

  19. 12-item Multiple Sclerosis Walking Scale (MSWS-12)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Self-reported questionnaire assessing impact of MS on walking ability (MSWS-12 scores: best 0, worst 100)

  20. Modified Fatigue Impact Scale (MFIS)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    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)

  21. Multiple Sclerosis Impact Scale (MSIS-29)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    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)

  22. Hospital Anxiety and Depression Scale (HADS)

    Time frame: From baseline to 3 months, 6 months, 12 months, and 24 months

    Self-reported questionnaire assessing impact of MS on anxiety (scores: best 0, worst 21) and depression (scores: best 0, worst 21)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 16, 2019
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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