NCT07899502Recruiting
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Real-World Effectiveness and Safety of Autologous Haematopoietic Stem Cell Transplantation and Other Therapeutic Strategies in Multiple Sclerosis (REAL-MS) - An Observational Database Study
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 12 Oct 2026
- Start date
- 7 Oct 2026
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Imperial College London
- Diseases
- Multiple sclerosis
- NCT number
- NCT07899502
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 7 Oct 2026 to the primary completion date, 31 Dec 2032
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Age
- Age \<18 years at the time of study inclusion;
Other
- 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;
- Lack of informed consent for prospective participation
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.