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

27 October 2026 NCT07899502 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
N/A
Participants
ALL
Age Range
18 Years+

About This Trial

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.

Who Can Join?

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

⚠ Always speak to your doctor before applying to any clinical trial.

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