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

NCT03806387 | Completed DMC FDA Drug

• 1 other identifier: MS_Improve
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Six minute walking test (6MWT)

  Change in maximal walking distance covered in 6 minutes

  From baseline to 24 months

Secondary Outcomes (22)

• Six minute walking test (6MWT)

  From baseline to 3 months, 6 months, and 12 months

• Timed 25 foot walk (T25FWT)

  From baseline to 3 months, 6 months, 12 months, and 24 months

• 5 times sit to stand test (5STS)

  From baseline to 3 months, 6 months, 12 months, and 24 months

• Timed Up and Go (TUG)

  From baseline to 3 months, 6 months, 12 months, and 24 months

• Stair Climbing test

  From baseline to 3 months, 6 months, 12 months, and 24 months

Interventions

Alemtuzumab DRUG

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

Also known as: Lemtrada

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis patients will be recruited from MS clinics all over Denmark.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Aarhus University, Health, Section for Sport Science

Aarhus, Jutland, 8000, Denmark

Location

Related Publications (1)

• Hvid LG, Stenager E, Dalgas U. Objectively assessed physiological, physical, and cognitive function along with patient-reported outcomes during the first 2 years of Alemtuzumab treatment in multiple sclerosis: a prospective observational study. J Neurol. 2022 Sep;269(9):4895-4908. doi: 10.1007/s00415-022-11134-7. Epub 2022 Apr 28.

  PMID: 35482080 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ulrik Dalgas, MSc,PhD

  Aarhus University, Health, Section for Sport Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: March 1, 2017
• Primary Completion: July 30, 2020
• Study Completion: June 30, 2021
• Last Updated: September 6, 2023

Record last verified: 2021-03

Locations

DK (1)