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Neurofilaments for NEDA Assessing in MS

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ClinicalTrials.gov Identifier: NCT03250169
Recruitment Status : Unknown
Verified July 2017 by Queen Mary University of London.
Recruitment status was:  Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Study Description
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Brief Summary:
Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Alemtuzumab

Detailed Description:

Primary

  1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.

    Secondary

  2. To assess prognosis at the end of the study based on neurofilament status.
  3. To correlate neurofilament levels with clinical and MRI markers of disease activity.
  4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Groups and Cohorts
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Intervention Details:
  • Drug: Alemtuzumab
    Licensed dose

Outcome Measures
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Primary Outcome Measures :
  1. Blood and CSF neurofilaments in Alemtuzumab patients over 24months [ Time Frame: 2 years ]
    Neurofilaments


Secondary Outcome Measures :
  1. Overall clinical response based on neurofilament response [ Time Frame: 2 years ]
    neurofilaments

  2. Neurofilament status and association with clinical and MRI markers of disease activity. [ Time Frame: 2 years ]
    Correlation index

  3. Longitudinal assessment of other biomarkers of inflammation & plasticity [ Time Frame: 2 years ]
    Correlation index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Relapsing-remitting MS
Criteria

Inclusion Criteria:

  1. Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
  2. Age 18-55 years.
  3. EDSS score between 0-5.5.
  4. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D

Exclusion Criteria:

  1. A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
  2. Those unable to comply with study requirement
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250169


Contacts
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Contact: Francesca Ammoscato 02078822282 f.ammoscato@qmul.ac.uk

Locations
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United Kingdom
Queen Mary University of London Recruiting
London, England, United Kingdom, E1 2AT
Contact: Francesca Ammoscato       f.ammoscato@qmul.ac.uk   
Sponsors and Collaborators
Queen Mary University of London
More Information
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03250169    
Other Study ID Numbers: 011717
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents