Skip to navigation Skip to content
Menu

Navigation

National Multiple Sclerosis Society

Sign In
In Your Area
DonateDonate
v
  • What Is MS?

    • Definition of MS
    • What Causes MS?
    • Who Gets MS?
    • Multiple Sclerosis FAQs
    • Types of MS
    • Related Conditions
  • Symptoms & Diagnosis

    • MS Symptoms
    • Diagnosing MS
    • Magnetic Resonance Imaging (MRI)
    • Cerebrospinal Fluid (CSF)
    • Possible MS
    • Clinically Isolated Syndrome (CIS)
    • Newly Diagnosed
    • Other Conditions to Rule Out
    • For Clinicians
  • Treating MS

    • Comprehensive Care
    • Find Doctors & Resources
    • Medications
    • Managing Relapses
    • Rehabilitation
    • Complementary & Alternative Medicines
    • For Clinicians
  • Resources & Support

    • Library & Education Programs
    • Find Support
    • Advanced Care Needs
    • Resources for Specific Populations
    • Find Programs & Services in Your Area
    • Calendar of Programs and Events
    • Find Doctors & Resources
  • Living Well with MS

    • Diet, Exercise & Healthy Behaviors
    • Emotional Well-Being
    • Spiritual Well-Being
    • Cognitive Health
    • Work, Home & Leisure
    • Relationships
  • Research

    • Participate in Research Studies
    • Research News & Progress
    • Research We Fund
    • For Researchers
  • Get Involved

    • Fundraising Events
    • Volunteer
    • Advocate for Change
    • Raise Awareness
    • Join the Community
    • Stay Informed
    • Corporate Support
    • Personal Stories
  • d What Is MS?
    • d Definition of MS
      • Myelin
      • Immune-Mediated Disease
    • d What Causes MS?
      • Viruses
      • Clusters
    • d Who Gets MS?
      • Pediatric MS
      • African Americans
      • Hispanics & Latinos
    • d Multiple Sclerosis FAQs
    • d Types of MS
      • Clinically Isolated Syndrome (CIS)
      • Relapsing-remitting MS (RRMS)
      • Secondary progressive MS (SPMS)
      • Primary progressive MS (PPMS)
    • d Related Conditions
      • Acute Disseminated Encephalomyelitis (ADEM)
      • Balo’s Disease
      • HTLV-I Associated Myelopathy (HAM)
      • Neuromyelitis Optica (NMO)
      • Schilder's Disease
      • Transverse Myelitis
  • d Symptoms & Diagnosis
    • d Diagnosing MS
    • d Magnetic Resonance Imaging (MRI)
    • d Cerebrospinal Fluid (CSF)
    • d Possible MS
    • d Clinically Isolated Syndrome (CIS)
    • d Newly Diagnosed
    • d Other Conditions to Rule Out
      • Lyme Disease
      • Lupus
      • Neuromyelitis Optica
      • Acute Disseminated Encephalomyelitis (ADEM)
    • d For Clinicians
  • d Treating MS
    • d Comprehensive Care
      • Developing a Healthcare Team
      • Make the Most of Your Healthcare Provider Visits
      • Advance Medical Directives
    • d Find Doctors & Resources
    • d Medications
      • Adherence
      • Patient Assistance Programs
      • Meds Used Off Label
      • Make Medications Accessible
      • Generic and Biosimilar - Medications
    • d Managing Relapses
      • Plasmapheresis
    • d Rehabilitation
      • Functional Electrical Stimulation (FES)
    • d Complementary & Alternative Medicines
      • Chiropractic Therapy
      • Marijuana
      • Massage and Bodywork
      • Acupuncture
      • Low-Dose Naltrexone
    • d For Clinicians
  • d Resources & Support
    • d Library & Education Programs
      • Webinar Series
      • Momentum Magazine
      • Educational Videos
      • Knowledge Is Power
      • Pathways to a Cure
      • Live Fully, Live Well
      • Everyday Matters
      • Free From Falls
      • Relationship Matters
      • Resilience: Addressing the Challenges of MS
      • Webcasts
      • DVDs
      • Books
      • For Kids: Keep S'myelin
      • Información en Español
      • Brochures
    • d Find Support
      • Ask an MS Navigator
      • Community at MSconnection.org
      • Join a Local Support Group
      • Peer Connections: One-on-One
      • Edward M. Dowd Personal Advocate Program
    • d Advanced Care Needs
      • Pressure Sores
      • Osteoporosis
      • Seeking Services: Questions to Ask
    • d Resources for Specific Populations
      • Pediatric MS Support
      • Veterans with Multiple Sclerosis
    • d Find Programs & Services in Your Area
    • d Calendar of Programs and Events
    • d Find Doctors & Resources
  • d Living Well with MS
    • d Diet, Exercise & Healthy Behaviors
      • Diet & Nutrition
      • Exercise
      • Heat & Temperature Sensitivity
      • Sleep
      • Vaccinations
      • Women's Health
      • Unhealthy Habits
      • Managing MS and Another Condition
      • Aging with MS
      • Anesthesia and Surgery
      • Managing Your MS
    • d Emotional Well-Being
      • Mood Changes
    • d Spiritual Well-Being
      • Building Spirituality into Your Life
    • d Cognitive Health
    • d Work, Home & Leisure
      • Employment
      • Insurance & Financial Information
      • Staying Mobile
      • Reclaiming Control
      • Accessibility
      • Technology
      • Recreation
      • Travel
      • Emergencies & Disasters
    • d Relationships
      • Disclosure
      • Family Matters
      • Parenting
      • Intimacy
      • Preventing Abuse
  • d Research
    • d Participate in Research Studies
      • Participate in a Clinical Trial
      • Surveys and Other Research Studies
      • Participate in Genetic Studies
      • Donate to Tissue Banks
    • d Research News & Progress
      • Research News
      • Stem Cells in MS
      • Progressive MS Research
      • Clinical Trials in MS
      • Wellness and Lifestyle Research
      • Diet
      • Vitamin D
      • How and Why Do Scientists Share Results
    • d Research We Fund
      • Stopping MS In Its Tracks
      • Restoring What's Been Lost
      • Ending the Disease Forever
      • How We Fund Research
      • FAQs about Society Research
      • Past Research Efforts
      • Driving Solutions
    • d For Researchers
  • d Get Involved
    • d Volunteer
      • Volunteer Information
      • Volunteer Recognition
    • d Advocate for Change
      • Become an MS Activist
      • Take Action
      • Current Advocacy Issues
      • Advocacy Results
      • Advocacy News
    • d Raise Awareness
    • d Join the Community
    • d Stay Informed
    • d Corporate Support
      • Corporate Partners
      • National Teams
      • Partnership Opportunities
    • d Personal Stories
      • Life with MS
      • Givers
      • Shakers
      • Families with MS
      • Seekers
      • Movers
      • Tributes
  • d Donate
    • d Support an Event Participant
    • d Donate Online
    • d Give in Honor or Memory
    • d Workplace Giving
    • d Employer Matching Gifts
    • d Gifts of Stock or Securities
    • d Giving Circles
      • Golden Circle
      • Circle of Distinction
      • Lawry Circle
      • Circle of Influence
    • d Planned Giving
    • d Other Ways to Give
      • Donate by Mail or Phone
  • d About the Society
    • d Vision
      • Strategic Plan
      • Independent Review of Society's Research Programs
    • d Careers
    • d Leadership
      • Board of Directors
      • Senior Leadership Team
      • Founder Sylvia Lawry
    • d Cultural Values
    • d Financials
      • Annual Reports
      • Sources of Support
    • d News
    • d Press Room
      • Events at a Glance
      • MS the Disease
      • Public Service Announcements
      • In the News Archives
    • d MS Prevalence
      • MS Prevalence FAQs
    • d Charitable Ratings
    • d Corporate Support and Programs
  • d Helpful Links
    • d Información en Español
    • d Site Map
    • d Site Tour
    • d Contact Us
  • d For Professionals
    • d Researchers
      • Society Funding
      • Deadlines
      • Apply Online
      • Funding Policies and Procedures
      • Scientific Peer Reviewers
      • Resources for Researchers
    • d Professional Resource Center
      • About MS
      • Diagnosing MS
      • Managing MS
      • Resources for You and Your Practice
      • Publications for Clinicians
      • Publications for Your Patients
      • MS Navigator Program
      • Programs and Services for Your Patients
      • Contact Us
      • Clinical Fellows
    • d Careers in MS
      • Clinical Care
      • Research
      • Have you met?
  • d Our Healthcare Voice
HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

Share this page

FacebookTwitterEmail

Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis

Study Purpose

MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK.and 2.5 million people worldwide. Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop significant disability within 10 years of onset, and 50% will require wheelchair assistance within 20 years. convenient, highly effective and CNS penetrant DMT for patients with relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years) treatment courses. It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of disease control in MS. Cladribine is the investigational product in this study as it not currently used to treat patients with an EDSS of 6.5

  • - 8.5.
This is a multi-centre, randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®) (3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance mechanistic understanding of its action in people with advanced MS (pwAMS).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

1. pwAMS aged 18+ years with an EDSS of 6.5-8.5 (inclusive) 2. History of bowel cancer screening for men, and women and cervical and breast cancer screening for women as per NHS recommended guidelines https://www.nhs.uk/conditions/nhs-screening/. 3. Ability to complete the 9HPT with at least one upper limb within 180 seconds. The average score of both attempts for each hand should be used to assess eligibility. 4. Confirmation of MS diagnosis according to the McDonald Criteria (2017) Thompson et al. 2018). 5. In the judgement of the investigator, evidence of deterioration of upper limb function during the 2 years running up to the screening date. Exclusion Criteria. 1. Participants with known hypersensitivity to Cladribine of any grade (as per CTCAE grading system) should be excluded. 2. Any uncontrolled diabetes, arterial hypertension and hypercholesterolaemia as determined by PI or delegated sub-investigator. 3. A history of stroke, deep vein or sinus venous thrombosis (including pulmonary embolus) and/or myocardial infarction. 4. Moderate to severe renal impairment (creatinine clearance <60 ml/min) 5. Moderate to severe hepatic impairment (Child-Pugh score >6) 6. Significant comorbidity, e.g. cardiac failure, renal failure, malignancy, or other health condition that in the view of the PI or delegated sub-investigator precludes participation. Patients who, following discussion with their cancer treatment team, are deemed to be cured from malignancy, may be eligible to participate as per the clinical judgement of the local PI. 7. Pregnancy including planning to father a child or breastfeeding. 8. Body weight less <40kg. 9. Unwillingness to use effective contraception throughout the trial period until at least six months after the last administration of IMP. This is not applicable for post-menopausal women. 10. Acute infection (uncontrolled) 11. Infection with Human Immunodeficiency Virus 1 and/or 2. 12. Active chronic infection (Syphilis, Tuberculosis, Hepatitis). Patients with active TB will be excluded. However, patients who have a positive IGRA, Elispot or Quantiferon test, but exhibit no symptoms for TB and evidence of a normal Chest X Ray, can be included in the study as per judgement of the local PI and after clarification with the CI. 13. Precancerous condition. 14. Total lymphocyte count <1.0*109/L. 15. Seronegativity for varicella zoster virus. Potential participants who are IgG negative may undergo vaccination, and can be screened again once full course has been completed. Seronegativity for all of the following: measles, mumps, rubella. Potential participants who are IgG negative for all 3 viruses, may undergo vaccination and can be screened again once full course has been completed. 16. Relapse within six months before screening. 17. Inability to complete an MRI (contraindications for MRI, including but not limited to, MRI-non-compatible pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry in the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, severe anxiety or claustrophobia etc.) or contraindication to Gd administration. 18. Treatment with steroids due to MS relapse/progression within three months of screening. pwAMS who fall in this category may undergo a further screening visit once the three months' window has expired and may be included if no steroid treatment has been administered in the intervening period. 19. Treatment with any interferon-beta, glatiramer acetate, teriflunomide or dimethyl-fumarate within three months before screening. 20. Treatment with natalizumab, fingolimod, siponimod, ponesimod, ozanimod (or other Sphingosine-1-phosphate receptor modulators) within three months of screening. 21. Treatment with azathioprine, methotrexate, or cyclosporine within six months before screening. 22. pwAMS treated with teriflunomide will need to undergo accelerated elimination of the compound before being considered (Research and Case Medical Research 2019). 23. Treatment with haematopoietic stem cell transplantation (HSCT), mitoxantrone, cyclophosphamide, cladribine, alemtuzumab or another B cell depleting compound, such as rituximab, ocrelizumab, ublitiuximab, ofatumumab, or biosimilars, unless the participant concerned has a memory B cell level of ≥20% of the CD19+ population in the peripheral blood. Such a level would normally not be expected earlier than a minimum of six months after the last drug administration. Participants who underwent such treatment will therefore have to be tested for their CD19+/CD27+ memory B cell level at screening. 24. Treatment with fampridine: If they are already on treatment for at least six months, participants should continue throughout the trial. However, starting continuous fampridine treatment after signing the consent sheet will lead to exclusion from treatment with IMP/placebo. 25. Concurrent participation or previous participation within the last 6 months in another clinical trial of an IMP or medical device. 26. Unable to swallow tablets

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04695080
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Queen Mary University of London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Multiple Sclerosis, Progressive Multiple Sclerosis
Arms & Interventions

Arms

Active Comparator: Cladribine (MAVENCLAD®)

Placebo Comparator: Placebo

Interventions

Drug: - Cladribine (MAVENCLAD®)

Cladribine (MAVENCLAD®) 3.5mg/kg, administered as weight-adjusted 10mg tablets in two treatment courses (12 months apart) lasting 8- 10 days each. Cladribine (MAVENCLAD®) 10mg available in blister packs of 1 tablet, 4 tablets and 6 tablets.

Drug: - Placebo

Placebo administered as weight adjusted tablets in two treatment courses (12 months apart) lasting 8-10 days each. Placebo 10mg available in blister packs of 1 tablet, 4 tablets and 6 tablets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Belfast, United Kingdom

Status

Recruiting

Address

Queens University Belfast (Belfast Health and Social Care Trust)

Belfast, , BT12 6BA

Site Contact

[email protected]

+44 (0)20 7882 6246

Birmingham, United Kingdom

Status

Recruiting

Address

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham

Birmingham, , B15 2TH

Site Contact

[email protected]

+44 (0)20 7882 6246

Cardiff University Hospital, Cardiff, United Kingdom

Status

Recruiting

Address

Cardiff University Hospital

Cardiff, , CF14 4XW

Site Contact

[email protected]

+44 (0)20 7882 6246

Coventry, United Kingdom

Status

Not yet recruiting

Address

University Hospitals of Coventry and Warwickshire NHS Trust

Coventry, , CV2 2DX

Site Contact

[email protected]

+44 (0)20 7882 6246

Edinburgh, United Kingdom

Status

Recruiting

Address

Anne Rowling Clinic, University of Edinburgh

Edinburgh, , EH16 4SB

Site Contact

[email protected]

+44 (0)20 7882 6246

Glasgow, United Kingdom

Status

Recruiting

Address

Queen Elizabeth University Hospital Glasgow

Glasgow, , G51 4TF

Site Contact

[email protected]

+44 (0)20 7882 6246

Glasgow, United Kingdom

Status

Recruiting

Address

University Hospital Hairmyres, NHS Lanarkshire

Glasgow, , G75 8RG

Site Contact

[email protected]

+44 (0)20 7882 6246

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Status

Recruiting

Address

Leeds Teaching Hospitals NHS Trust

Leeds, , LS1 3EX

Site Contact

[email protected]

+44 (0)20 7882 6246

Walton Centre NHS Trust, Liverpool, United Kingdom

Status

Recruiting

Address

Walton Centre NHS Trust

Liverpool, , L9 7LJ

Site Contact

[email protected]

+44 (0)20 7882 6246

Royal London Hospital, London, United Kingdom

Status

Recruiting

Address

Royal London Hospital

London, , E1 1FR

Site Contact

[email protected]

+44 (0)20 7882 6246

Royal Free London NHS Foundation Trust, London, United Kingdom

Status

Recruiting

Address

Royal Free London NHS Foundation Trust

London, , NW3 2QG

Site Contact

[email protected]

+44 (0)20 7882 6246

London, United Kingdom

Status

Recruiting

Address

Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)

London, , RM7 0AG

Site Contact

[email protected]

+44 (0)20 7882 6246

Lewisham and Greenwich NHS Trust, London, United Kingdom

Status

Recruiting

Address

Lewisham and Greenwich NHS Trust

London, , SE13 6LH

Site Contact

[email protected]

+44 (0)20 7882 6246

London, United Kingdom

Status

Recruiting

Address

St George's University Hospitals NHS Foundation Trust

London, , SW17 0RE

Site Contact

[email protected]

+44 (0)20 7882 6246

Luton and Dunstable Hospital, Luton, United Kingdom

Status

Recruiting

Address

Luton and Dunstable Hospital

Luton, , LU4 0DZ

Site Contact

[email protected]

+44 (0)20 7882 6246

Salford Royal Hospital NHS Trust, Manchester, United Kingdom

Status

Recruiting

Address

Salford Royal Hospital NHS Trust

Manchester, , M6 8HD

Site Contact

[email protected]

+44 (0)20 7882 6246

Aneurin Bevan University Health Board, Newport, United Kingdom

Status

Recruiting

Address

Aneurin Bevan University Health Board

Newport, , NP20 2UB

Site Contact

[email protected]

+44 (0)20 7882 6246

Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospital (Nottingham University Hospitals NHS Trust)

Nottingham, , NG7 2UH

Site Contact

[email protected]

+44 (0)20 7882 6246

University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom

Status

Recruiting

Address

University Hospitals Plymouth NHS Trust

Plymouth, , PL6 8DH

Site Contact

[email protected]

+44 (0)20 7882 6246

Sheffield, United Kingdom

Status

Recruiting

Address

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , S10 2JF

Site Contact

[email protected]

+44 (0)20 7882 6246

Stoke-on-Trent, United Kingdom

Status

Not yet recruiting

Address

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, , ST4 6QG

Site Contact

[email protected]

+44 (0)20 7882 6246

Morriston Hospital, Swansea, Swansea, United Kingdom

Status

Recruiting

Address

Morriston Hospital, Swansea

Swansea, , SA6 6NL

Site Contact

[email protected]

+44 (0)20 7882 6246

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Colophon

 

Stay Informed

Join Us

Facebook Twitter Instagram LinkedIn YouTube MS Connection
  • About the Society
    • Vision
    • Careers
    • Leadership
    • Cultural Values
    • Financials
    • News
    • Press Room
    • MS Prevalence
    • Charitable Ratings
    • Corporate Support
  • Helpful Links
    • Donate
    • MSConnection Blog
    • Información en Español
    • Glossary
    • Legal Notice/Privacy Policy
    • Site Map
    • Site Tour
    • Contact Us
  • For Professionals
    • Researchers
    • Physicians
    • Nurses
    • Rehabilitation Professionals
    • Mental Health Professionals
    • Health and Wellness Professionals
  • What Is MS?
  • Symptoms & Diagnosis
  • Treating MS
  • Resources & Support
  • Living Well with MS
  • Research
  • Get Involved
Hidden Link