Completed (inferred)MS (type not specified)ISRCTN69709064

What it found

No result found

We found no results in the registry or in papers.

What it measured

Main measures

  • EBV viral loads in cell-free plasma, peripheral blood mononuclear cells, B-cells, memory B-cells and saliva measured using a standard EBV-specific RT-qPCR assay at time zero, 12 and 24 months

    Thinking and memoryImmune response

Other measures (1)

  • 1. EBV genome analysis and B cell repertoire analysis using DNA extraction, library construction, targeted enrichment and sequencing at time zero, at 12 months and at 24 months? 2. Proportion of subjects with MS who generate LCLs compared to healthy control subjects measured using LCLs ex vivo in cell culture lines numbers Time points are not relevant as this is a cross-sectional biomarker study w

    Blood or spinal fluid markersImmune response

Who could take part

MS (type not specified) · 18 and over

Inclusion: People with MS (pwMS): 1. Diagnosis of Multiple Sclerosis according to the McDonald criteria (Thompson et al. 2018) 2. Age above 18 years 3. Informed consent Normal controls (healthy volunteers): 1. Age above 18 years 2. Informed consent 3. Absent of a pre-existing autoimmune disease, for example, type diabetes mellitus, autoimmune thyroid disease, inflammatory bowel disease, psoriasis, etc Exclusion: People with MS and healthy subjects: 1. Other pre-existing autoimmune diseases, for example, type I diabetes mellitus, autoimmune thyroid disease, inflammatory bowel disease, psoriasis, etc 2. Unable to comply with study requirements 3. Unable to give informed consent to participate

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Multiple sclerosis (MS) is an autoimmune disorder affecting the central nervous system. Data supports Epstein Barr Virus (EBV) as being necessary, but not sufficient, for someone to develop MS. The memory B-cell population is a subset of immune cells that has been suggested to be the cell population driving MS. The memory B cell population, which contains the subset of cells that are latently infected with EBV, is critical in the development of MS and is likely to be the main target of licensed MS treatments. The aim of this study is to see if people with MS have evidence of ongoing EBV replication compared to healthy volunteers, and whether or not MS treatments impact EBV replication. Who can participate? People with MS and healthy volunteers aged 18 years or above. What does the study involve? Participants will be asked to provide up to three extra blood and saliva samples. They will be asked to complete a questionnaire regarding their demographics, medical history, current medications and natural history of MS. No personal identifiers will be collected as part of the questionnaire. What are the possible benefits and risks of participating? Blood tests are a safe procedure but there can be complications, such as bruising at the site of puncture and excessive bleeding. The researchers will minimise the risk of complications by having trained personnel perform the blood extraction in accordance with infection control guidelines. They are not aware of any risk linked to taking saliva samples. There is no immediate benefit to participants, but it is hoped that the findings from this study will help with the development of new MS treatments in the future. Where is the study run from? Queen Mary University of London and Barts NHS Trust (UK) When is the study starting and how long is it expected to run for? October 2021 to February 2026 Who is funding the study? Horne Family Foundation (UK) Who is the main contact? 1. Dr Louisa James, louisa.james@qmul.ac.uk 2. Prof. David Baker, david.baker@qmul.ac.uk 3. Prof. Gavin Giovannoni, g.giovannoni@qmul.ac.uk 4. Adekunle Adeyinka Adeniran, a.a.adeniran@qmul.ac.uk

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History

    1. Started

      Sept 2022

    2. Finished

      Feb 2026

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