Multiple Sclerosis
Conditions
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.
Interventions
DRUGAlemtuzumab
Licensed dose
Sponsors
Queen Mary University of London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood and CSF neurofilaments in Alemtuzumab patients over 24months | 2 years | Neurofilaments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall clinical response based on neurofilament response | 2 years | neurofilaments |
| Neurofilament status and association with clinical and MRI markers of disease activity. | 2 years | Correlation index |
| Longitudinal assessment of other biomarkers of inflammation & plasticity | 2 years | Correlation index |
Countries
United Kingdom
Outcome results
None listed