NCT04053374

Brief Summary

The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 24, 2020

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 5, 2019

Last Update Submit

April 22, 2020

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (7)

  • Lipid Phenotyping (1)

    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)

    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

    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

    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)

    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)

    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

    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

Study Arms (6)

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.

Other: Blood sampling

Secondary Progressive Multiple Sclerosis (SPMS)

People with confirmed diagnosis of SPMS

Other: Blood sampling

Primary Progressive Multiple Sclerosis (PPMS)

People with confirmed diagnosis of PPMS

Other: Blood 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

Other: Blood 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.

Other: Blood 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.

Other: Blood sampling

Interventions

Blood samplingOTHER

Blood sampling +/- CSF sampling

Also known as: CSF sampling
DMD treatment naive CIS or RRMS patientsDMD-treated with stable diseaseDisease controlsHealthy donorsPrimary Progressive Multiple Sclerosis (PPMS)Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with and those without MS

You may qualify if:

  • \. 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.
  • \. Having given written informed consent prior to undertaking any study-related procedures.
  • \. 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.
  • \. 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.

You may not qualify if:

  • \. Patients currently taking statins or other lipid lowering therapies.
  • \. Under any administrative or legal supervision.
  • \. 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample Cerebral Spinal Fluid (CSF) sample

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rachel Farrell, Dr

    UCL & University College London Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Jury, Prof

CONTACT

02031082161e.jury@ucl.ac.uk

Kirsty Waddington, Dr

CONTACT

02031082167kirsty.waddington.13@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 12, 2019

Study Start

September 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

April 24, 2020

Record last verified: 2019-08

Locations

GB(2)