Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing-Remitting Multiple Sclerosis (MS).
Multiple Sclerosis (MS) is a disease of the central nervous system that affects 2.3 million people worldwide. It is caused by an autoimmune reaction that damages nerve cells. This damage to the nerve cells interrupts signals and results in a wide range of symptoms that can affect movement, eyesight and cognition.
Around 85% of people who are diagnosed with MS have relapsing-remitting MS (RRMS). There is no cure for MS, but some RRMS patients respond well to Disease Modifying Therapies.
More recently, Autologous Haematopoietic Stem Cell Therapy (aHSCT) has shown promise for treating a number of autoimmune diseases, including RRMS. Haematopoietic stem cells are young cells that have the potential to become mature immune cells. These cells are collected from patients, by a process called mobilisation. The patients then undergo chemotherapy to wipe out their overactive immune cells (conditioning), before the stem cells are infused back into the bloodstream.
There is growing clinical evidence that aHSCT can treat RRMS more effectively than DMTs. However, as most data is registry-based and previous trials did not directly compare aHSCT with the most efficacious DMTs, Alemtuzumab, Ocrelizumab, Cladribine and Ofatumumab, questions remain over the relative efficacy and safety of aHSCT over the UK standard of care for highly active RRMS. The StarMS trial aims to address these questions
StarMS 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 RRMS.
The study aims to recruit 198 patients from 19 sites across the UK. Participants in the study will be randomly allocated to receive either aHSCT or treatment with a ‘highly effective’ DMT (Alemtuzumab, Ocrelizumab, Cadribine, or Ofatumumab). 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.
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.
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.
More information about the trial can be found on our trial website.
|Bart's and the London NHS Trust||Open|
|University Hospitals Birmingham NHS Foundation Trust||In set-up|
|Cambridge University Hospitals NHS Foundation Trust||Open|
|Cardiff & Vale University Health Board||In set-up|
|NHS Greater Glasgow and Clyde||In set-up|
|Imperial College Healthcare NHS Trust||Open|
|King's College Hospital NHS Foundation Trust||Open|
|Leeds Teaching Hospitals NHS Trust||Open|
|The Newcastle upon Tyne Hospitals NHS Foundation Trust||In set-up|
|North Bristol NHS Trust||In set-up|
|Nottingham University Hospitals NHS Trust||Open|
|Oxford University Hospitals NHS Foundation||In set-up|
|University Hospitals Plymouth NHS Trust||In set-up|
|Salford Royal NHS Foundation Trust||Open|
|Sheffield Teaching Hospitals NHS Foundation Trust||Open|
|University Hospital Southampton NHS Foundation Trust||Open|
|The Walton Centre NHS Foundation Trust||In set-up|
|University College London Hospitals NHS Foundation Trust||Open|
|Prof John Snowden||Chief Investigator||Sheffield Teaching Hospitals NHS Foundation Trust||John.email@example.com|
|Prof Basil Sharrack||Lead Trial Neurologist||Sheffield Teaching Hospitals NHS Foundation Trust||Basil.firstname.lastname@example.org|
|Prof Paolo Muraro||Lead Trial Neurologist||Imperial College Healthcare NHS Trustemail@example.com|
|Prof Cindy Cooper||Director, CTRU||CTRU, University of Sheffield||
|Diana Papaioannou||Assistant Director, CTRU||CTRU, University of Sheffield||
|Prof Stephen Walters||Senior Statistician||CTRU, University of Sheffield||
|Amanda Loban||Head of Data Management||CTRU, University of Sheffieldfirstname.lastname@example.org|
|Sarah Gonzalez||Trial Support Officer||CTRU, University of Sheffieldemail@example.com|
|Rachel Glover||Trial Manager||CTRU, University of Sheffieldfirstname.lastname@example.org|
|Katie Hullock||Research Assistant||CTRU, University of Sheffieldemail@example.com|
|Kate Duffy||Research Assistant||CTRU, University of Sheffieldfirstname.lastname@example.org|
Generic email for StarMS trial: email@example.com
This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. The sponsor is the Sheffield Teaching Hospitals NHS Foundation Trust.
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