StarMS
Research type
Research Study
Full title
A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis.
IRAS ID
265127
Contact name
John Snowden
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Eudract number
2019-001549-42
ISRCTN Number
ISRCTN88667898
Duration of Study in the UK
4 years, 8 months, 25 days
Research summary
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system (CNS) which leads to impairment in strength, sensation, balance, vision, cognition and sphincter function. For patients with highly active relapsing remitting MS (RRMS), disease modifying therapies (DMTs) are available however there is growing evidence that autologous haematopoietic stem cell transplantation (aHSCT) may be more effective in reducing relapse rates and improving disability and quality of life.\n\nThe StarMS trial will compare aHSCT against the two most effective DMTs currently available in the UK, alemtuzumab and ocrelizumab. \n\nPatients with highly active RRMS will be recruited from across the UK and randomised to receive either aHSCT or a disease modifying therapy (alemtuzumab or ocrelizumab). For patients who receive aHSCT, some of their stem cells will be removed (harvested) from their peripheral blood and stored. Patients will then undergo a process to eliminate their immune cells. Then the stem cells that were harvested earlier are transplanted (re-infused) back into the patients’ blood. The re-infused stem cells give rise to a new generation of immune cells, replacing cells of the original ‘sick’ immune system. \n\nPatients who are allocated to the DMT arm will receive either alemtuzumab or ocrelizumab. The local treating clinician will decide which treatment each patient should receive based on standard clinical criteria and will involve patients in this decision. In patients who receive alemtuzumab, the drug will given as an intravenous (IV) infusion on 2 occasions 12 months apart. In patients who receive ocrelizumab, the drug is given as an IV infusion at 6-monthly intervals.\n\nParticipants will be followed up within the trial for 2 years to compare the efficacy of aHSCT against these two DMTs. The safety profile of both treatment options will also be compared along with effects on cognitive function and quality of life.\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0061
Date of REC Opinion
20 Mar 2020
REC opinion
Favourable Opinion