Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis (RELOAD-MS)

22 april 2020 bijgewerkt door: University College, London
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 protective) do not work properly and cannot block the harmful effects of the activated immune cells effectively.

Immune cells work via a complex system of signals that start on the outside layer of the cell (the plasma membrane), these signals are transmitted inside the cell where they trigger immune cell activation. The plasma membrane consists of a fatty layer and changes in the type of fat in the membrane can affect immune cell signalling and immune cell function.

The aims of this project are to:

  1. Identify what is different about the types of fat in immune cells from healthy donors and people with MS and identify what triggers the production of these different types of fat.
  2. Identify how different types of fat control immune cell function in healthy donors and people with MS
  3. Identify possible ways to regulate the type of fat in immune cell membranes to restore normal immune cell function in MS.

Methods: This research study involves collecting participant demographic and clinical information, blood and Cerebral Spinal Fluid (CSF) (optional) from patients with MS. Blood will also be collected from healthy volunteers for comparison. Experiments will be performed on the blood samples and the results correlated with the clinical and disease features of patients.

Outcomes: Many of the molecules involved in the generation of fats are well known and for some of them drugs are already used in humans to treat diseases (for example statins). This could allow the rapid translation of the results from this study to the clinic and have a direct impact for people with MS.

Studietype

Observationeel

Inschrijving (Verwacht)

275

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, NW1 2BU
        • Werving
        • University College London Hospitals NHS Foundation Trust
        • Contact:
      • London, Verenigd Koninkrijk, WC1N 3BG
        • Werving
        • National Hospital For Neurology and Neurosurgery
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Those with and those without MS

Beschrijving

Inclusion Criteria:

  • 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 Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
DMD treatment naive CIS or RRMS patients
Newly presenting Clinically Isolated Syndrome (CIS) or Relapsing and Remitting Multiple Sclerosis (RRMS) patients not treated before with Disease Modifying Drugs (DMD) Additional analysis of CSF and CSF cells will be performed in this cohort on a voluntary basis.
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling
Secondary Progressive Multiple Sclerosis (SPMS)
People with confirmed diagnosis of SPMS
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling
Primary Progressive Multiple Sclerosis (PPMS)
People with confirmed diagnosis of PPMS
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling
DMD-treated with stable disease
People with Multiple Sclerosis (MS) who are treated with DMD who have had stable disease symptoms for at least 3 months
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling
Disease controls
People who undergo lumbar puncture due to clinical suspicion of neurological condition, but brain Magnetic Resonance Imaging (MRI) and CSF examination exclude MS diagnosis.
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling
Healthy donors
Age, sex and ethnicity matched healthy donors will also be recruited from university and hospital staff and patient friends after informed consent has been obtained. Healthy donors will be asked to provide a blood sample and demographic information but will NOT be asked to provide CSF samples.
Ander: Blood sampling
Blood sampling +/- CSF sampling
Andere namen:
  • CSF sampling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Lipid Phenotyping (1)
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London (UCL), Rayne Building for lipid phenotyping of PBMC using flow cytometry
4 hours from point of sample collection
Lipid Phenotyping (2)
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for lipid phenotyping of PBMC using measurement of quantitative polymerase chain reaction (qPCR)
4 hours from point of sample collection
Analysis of immune cell function
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function using flow cytometry.
4 hours from point of sample collection
Analysis of cytokine
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of cytokine using flow cytometry.
4 hours from point of sample collection
Analysis of immune cell function (1)
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through cell culture.
4 hours from point of sample collection
Analysis of immune cell function (2)
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through flow cytometry.
4 hours from point of sample collection
Analysis of serum
Tijdsspanne: 4 hours from point of sample collection
Blood samples collected from consented participants containing serum will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for measurement of chemokine, lipid expression and expression of other molecules important for immune cell activation.
4 hours from point of sample collection

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University College, London

Medewerkers

University College London Hospitals

Onderzoekers

  • Hoofdonderzoeker: Rachel Farrell, Dr, UCL & University College London Hospitals NHS Foundation Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2018

Primaire voltooiing (Verwacht)

1 juni 2020

Studie voltooiing (Verwacht)

1 juni 2020

Studieregistratiedata

Eerst ingediend

5 augustus 2019

Eerst ingediend dat voldeed aan de QC-criteria

9 augustus 2019

Eerst geplaatst (Werkelijk)

12 augustus 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 april 2020

Laatste update ingediend die voldeed aan QC-criteria

22 april 2020

Laatst geverifieerd

1 augustus 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18/0057

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

All participants indicate by written consent if they are willing to allow any of their un-used samples and associated data to be used for future research MS related research.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren