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REAL-MS: Observational Database Study of AHSCT and MS Therapies

Recruitingn/aAges 18 Years - anyAllImperial College London
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In plain words

What the trial is, and whether it could suit you

Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system. REAL-MS is an observational study that will collect and analyse information from routine clinical care to compare the longer-term effectiveness and safety of AHSCT with high-efficacy disease-modifying therapies for adults with MS. High-efficacy therapies include medicines such as alemtuzumab, cladribine, natalizumab, and anti-CD20 antibody treatments, as well as other high-efficacy disease-modifying therapies that may become available during the study.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of MS according to the appropriate diagnostic criteria at the time of diagnosis; * Age โ‰ฅ 18 years old at the time of the inclusion in the study; * Treatment with AHSCT or a H-E DMT at a participating centre. Eligible H-E DMTs will include anti-CD20 monoclonal antibodies, natalizumab, alemtuzumab, cladribine, and other therapies approved by the study management group during the study period; * Availability of a minimum required baseline dataset as defined in the study case report form and data dictionary; * Availability of at least one post-baseline clinical assessment, unless the patient is included in safety analyses only; * For participation in the prospective phase of the study, capacity to provide informed consent, as judged by the investigator, and provision of written informed consent where required by applicable local regulations and ethics approvals; Exclusion Criteria: * Age \<18 years at the time of study inclusion; * Insufficient baseline data to confirm eligibility, treatment exposure, or key study variables; * No post-baseline follow-up data, unless the participant is included in safety analyses only; * Concurrent participation in an interventional randomised controlled trial where inclusion in the study would conflict with the trial protocol or compromise interpretation of study outcomes; * Lack of informed consent for prospective participation
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What it tests

  • Autologous haematopoietic stem cell transplantation (AHSCT)
  • High-efficacy disease-modifying therapy (HE-DMT)
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Where

3 sites
Imperial College Healthcare NHS Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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