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RECRUITING
NCT07899502

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

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

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.

Official title: Real-World Effectiveness and Safety of Autologous Haematopoietic Stem Cell Transplantation and Other Therapeutic Strategies in Multiple Sclerosis (REAL-MS) - An Observational Database Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2026-10-07

Completion Date

2032-12-31

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous haematopoietic stem cell transplantation (AHSCT)

Exposure to autologous haematopoietic stem cell transplantation received as part of routine clinical care for multiple sclerosis. AHSCT uses the participant's own blood-forming stem cells following immune-suppressing treatment. Treatment is not assigned or administered by the study.

DRUG

High-efficacy disease-modifying therapy (HE-DMT)

Exposure to an eligible high-efficacy disease-modifying therapy received as part of routine clinical care for multiple sclerosis. Therapies may include alemtuzumab, cladribine, natalizumab, anti-CD20 monoclonal antibody therapies, and other eligible high-efficacy disease-modifying therapies available during the study. Treatment is not assigned or administered by the study.

Locations (3)

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