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Clinical Trials/NCT03250169
NCT03250169TerminatedNot Applicable

Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study

Queen Mary University of London1 site in 1 country21 target enrollmentStarted: August 1, 2017Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
21
Locations
1
Primary Endpoint
Blood and CSF neurofilaments in Alemtuzumab patients over 24months
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
  • •Age 18-55 years.
  • •EDSS score between 0-5.
  • •Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D

Exclusion Criteria

  • •A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
  • •Those unable to comply with study requirement

Outcomes

Primary Outcomes

Blood and CSF neurofilaments in Alemtuzumab patients over 24months

Time Frame: 2 years

Neurofilaments

Secondary Outcomes

  • Overall clinical response based on neurofilament response(2 years)
  • Longitudinal assessment of other biomarkers of inflammation & plasticity(2 years)
  • Neurofilament status and association with clinical and MRI markers of disease activity.(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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