REAL-MS: Observational Database Study of AHSCT and MS Therapies
Sponsored by Imperial College London
About This Study
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.
Conditions Studied
Interventions
- •Autologous haematopoietic stem cell transplantation (AHSCT)
- •High-efficacy disease-modifying therapy (HE-DMT)
Eligibility
View full eligibility criteria
Inclusion Criteria: * Diagnosis of MS according to the appropriate diagnostic criteria at the time of diagnosis; * Age ≥ 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