Multiple SclerosisRELOAD-MSNCT04053374
Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University College, London at 2 sites in United Kingdom.
Trial summary
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood sampling
- How many people
- 275 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2018to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those with and those without MS
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Kirsty Waddington, Dr, 02031082167, kirsty.waddington.13@ucl.ac.uk
- Recruiting
National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Rachel Farrell, Dr, 02034483561, rachel.farrell@ucl.ac.uk
About this study
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.
Read the 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 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:
- 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.
- Identify how different types of fat control immune cell function in healthy donors and people with MS
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood sampling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Also called CSF sampling
Blood sampling +/- CSF sampling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sampling | |
| Secondary Progressive Multiple Sclerosis (SPMS) | People with confirmed diagnosis of SPMS Receives: Other: Blood sampling | |
| Primary Progressive Multiple Sclerosis (PPMS) | People with confirmed diagnosis of PPMS Receives: 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 Receives: 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. Receives: 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. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours from point of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Sep 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Rachel Farrell, Dr, Principal investigator, UCL & University College London Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053374
- Sponsor's protocol ID
- 18/0057
- Acronym
- RELOAD-MS
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04053374
- Acronym / sponsor ID
- RELOAD-MS / 18/0057
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- 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.
- Identify how different types of fat control immune cell function in healthy donors and people with MS
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DMD treatment naive CIS or RRMS patients | – | Other: Blood samplingNewly 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. |
| Secondary Progressive Multiple Sclerosis (SPMS) | – | Other: Blood samplingPeople with confirmed diagnosis of SPMS |
| Primary Progressive Multiple Sclerosis (PPMS) | – | Other: Blood samplingPeople with confirmed diagnosis of PPMS |
| DMD-treated with stable disease | – | Other: Blood samplingPeople with Multiple Sclerosis (MS) who are treated with DMD who have had stable disease symptoms for at least 3 months |
| Disease controls | – | Other: Blood samplingPeople who undergo lumbar puncture due to clinical suspicion of neurological condition, but brain Magnetic Resonance Imaging (MRI) and CSF examination exclude MS diagnosis. |
| Healthy donors | – | Other: Blood samplingAge, 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those with and those without MS
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAlso: CSF samplingBlood sampling +/- CSF sampling | Other | DMD treatment naive CIS or RRMS patients, DMD-treated with stable disease, Disease controls, Healthy donors, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS) |
Primary outcome
Lipid Phenotyping (1)
Time frame: 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
Lipid Phenotyping (2)
Time frame: 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)
Analysis of immune cell function
Time frame: 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.
Analysis of cytokine
Time frame: 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.
Analysis of immune cell function (1)
Time frame: 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.
Analysis of immune cell function (2)
Time frame: 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.
Analysis of serum
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Farrell, Dr principal investigator
UCL & University College London Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liz Jury, Prof (02031082161, e.jury@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Phenotyping (1) (time frame: 4 hours from point of sample collection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.