- REAL-MS: Observational Database Study of AHSCT and MS Therapies — Recruiting • Neurology • NCT07899502.
- Sponsor: Imperial College London.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.…
- : * 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;
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.