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The StarMS trial aims to compare the efficacy and safety profile of Autologous Haematopoietic Stem Cell Transplantation (aHSCT) vs ‘highly effective’ Disease Modifying Therapies (DMTs) – Ocrelizumab, Alemtuzumab, Cladribine and Ofatumumab. The study will also research the mechanism of action to help our understanding of how aHSCT works in relapsing remitting MS (RRMS).
The trial is for patients with RRMS or rapidly evolving severe MS in treatment naïve patients.
The study aims to recruit 198 patients from 19 sites across the UK. All participants will be followed up over a 24 month period involving regular visits with the study team. Study visits will include blood tests, neurology examinations and questionnaires.
Trial Treatments
Trial Treatments
Eligible participants will be randomly allocated to receive one of the following treatments:
aHSCT
aHSCT
Participants allocated to the aHSCT arm will have stem cells removed (harvested) from the blood. Participants will then undergo ‘conditioning’ where the patients receive chemotherapy before their stem cells are transplanted (re-infused) into the participants’ blood. The re-infused stem cells give rise to a new generation of immune cells, replacing the original ‘sick’ immune system.
DMT
DMT
Participants allocated to the DMT arm will receive either Alemtuzumab, Ocrelizumab, Cladribine, or Ofatumumab administered and monitored as per licence. This decision will be based on the participant’s suitability for each drug based on current guidelines as well as clinician/participant preference.
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