Neurofilaments for NEDA Assessing in MS

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03250169
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
Multiple Sclerosis	Drug: Alemtuzumab

Detailed Description

Primary

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

Secondary

1. To assess prognosis at the end of the study based on neurofilament status.

2. To correlate neurofilament levels with clinical and MRI markers of disease activity.

3. 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
• Actual Enrollment: 21 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: Aug 1, 2017
• Actual Primary Completion Date: Jan 28, 2022
• Actual Study Completion Date: Jan 28, 2022

Outcome Measures

Primary Outcome Measures

1. Blood and CSF neurofilaments in Alemtuzumab patients over 24months [2 years]

   Neurofilaments

Secondary Outcome Measures

1. Overall clinical response based on neurofilament response [2 years]

   neurofilaments

2. Neurofilament status and association with clinical and MRI markers of disease activity. [2 years]

   Correlation index

3. Longitudinal assessment of other biomarkers of inflammation & plasticity [2 years]

   Correlation index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary University of London	London	England	United Kingdom	E1 2AT

Sponsors and Collaborators

• Queen Mary University of London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT03250169
• Other Study ID Numbers: 011717
• First Posted: Aug 15, 2017
• Last Update Posted: Feb 25, 2022
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Multiple Sclerosis; Sclerosis; Alemtuzumab

Study Results

No Results Posted as of Feb 25, 2022