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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Klaus
Schmierer
k.schmierer@qmul.ac.uk
Dr
Klaus
Schmierer
k.schmierer@qmul.ac.uk
Demyelinating diseases of the central nervous system
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK. 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.
Cladribine tablets are a safe, convenient, highly effective and CNS penetrant DMT for patients with relapsing-remitting 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).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Immunotherapy;
You can take part if:
You may not be able to take part if:
1. Known hypersensitivity to cladribine of Grade 3 or Grade 4 severity according to the Common Terminology Criteria for Adverse Events (CTCAE) grading system 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 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 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 11. Infection with Human Immunodeficiency Virus 1 and/or 2 12. Active chronic infection (Syphilis, Tuberculosis, Hepatitis) 13. Precancerous condition or previous diagnosis of cancer 14. Total lymphocyte count < 1.0*109/mL 15. Seronegativity for varicella zoster IgG, rubella, measles, mumps. Potential participants who fall in this category 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Queen Mary University of London and funded by BARTS CHARITY; MERCK SERONO LIMITED; MULTIPLE SCLEROSIS SOCIETY; National Multiple Sclerosis Society; NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); .
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Read full details
for Trial ID: CPMS 47180
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