Status:
UNKNOWN
Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis
Lead Sponsor:
University College, London
Collaborating Sponsors:
University College London Hospitals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Brief Summary
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.
Detailed Description
In Multiple Sclerosis (MS) immune cells recognise myelin, the coating around nerve fibres, as a foreign molecule and attack it by mistake; at the same time regulatory immune cells (which are normally ...
Eligibility Criteria
Inclusion
- 01\. Male and female patients of between 18 years and 80 years of age with a diagnosis of MS or CIS.
- Diagnosis confirmed according to the standards at the time when diagnosis was made.
- Patients not receiving biological DMDs within the previous 3 months OR
- Patients treated with DMDs (Interferon beta (Rebif, Betaferon, Avonex, Plegridy), Glatiramer Acetate (Copaxone), Dimethylfumarate (Tecfidera), Fingolimod (Gilenya), Teriflunomide (Aubagio), Natalizumab (Tysabri),) Alemtuzumab (Lemtrada), immunosuppressive drugs (azathioprine, cyclophosphamide etc) who have stable disease in the last 3 months.
- Last course of corticosteroids more than three months ago.
- 02\. Having given written informed consent prior to undertaking any study-related procedures.
- 03\. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- 04\. Healthy donors ONLY : Male and female donors of between 18 years and 80 years of age in good health and not aware of any diagnosis of an autoimmune condition.
Exclusion
- 01\. Patients currently taking statins or other lipid lowering therapies.
- 02\. Under any administrative or legal supervision.
- 03\. Conditions/situations such as:
- Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
- Impossibility to meet specific protocol requirements (e.g. blood sampling)
- Patient is the Investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
- Pregnant or breast-feeding women, currently or in the last three months prior to inclusion
- Patients who have been vaccinated in the last three months prior to inclusion
- Healthy donors ONLY: will be excluded from the study if:
- Donors with a condition likely to influence your blood results such as a current infection or cancer
- Donors who are pregnant or breast-feeding currently or in the last three months
- Donors who have been vaccinated within the last three months
- Donors who cannot provide a blood sample
- Donors who are unable to give informed consent
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT04053374
Start Date
September 1 2018
End Date
June 1 2020
Last Update
April 24 2020
Active Locations (2)
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1
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
2
National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG