The StarMS Trial

A clinical trial aiming to compare the efficacy and safety of Autologous Haematopoietic Stem Cell Transplantation versus 'highly effective' Disease Modifying Treatments.

Condition(s)

  • Multiple sclerosis

About the project

Around 85% of people who are diagnosed with multiple sclerosis (MS) have relapsing-remitting MS (RRMS). There is no cure for MS, but some people living with RRMS respond well to disease-modifying therapies (DMTs).

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 (this process is called 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 standard care for highly active RRMS. The StarMS trial aims to address these questions.

About the project

StarMS aims to compare the efficacy and safety profile of Autologous Haematopoietic Stem Cell Transplantation (aHSCT) versus 'highly effective' disease-modifying therapies (DMTs).

The StarMS trial is led by the University of Sheffield. The Anne Rowling Clinic is one of 19 sites across the UK to recruit participants to the StarMS clinical trial and is the only recruiting site in Scotland.

Participants in the trial will be randomly allocated to receive either aHSCT or treatment with a 'highly effective' DMT. Participants allocated to the aHSCT arm will have stem cells removed (harvested) from the blood. Participants will then undergo 'conditioning' where the participants will receive chemotherapy before their stem cells are transplanted (re-infused) into the participant's 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 the medication 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 trial team. Trial appointments will include blood tests, neurological examinations, MRI scan, and questionnaires.

Eligibility

Complete the Eligibility Questionnaire to see if you might be eligible for the trial. Potentially eligible participants will undergo a number of screening assessments, and each case will be reviewed by a central team of neurologists involved in the study. This is to ensure that patients only take part in the trial, and receive the trial treatment(s), if it is right for them and their condition.

Related information

If you'd like to know more about StarMS visit the University of Sheffield's StarMS website which has further information and resources, including details of the participating centres, and frequently asked questions.

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

Funder(s)

EME Programme (Efficacy and Mechanism Evaluation Programme), MRC and NIHR partnership

Publication(s)

Status

Recruiting now

Contact

Dawn Lyle, Lead Research Nurse
dawn.lyle@nhs.scot
0131 465 9517

Eligibility criteria

The eligibility criteria are correct at the time of publication.

Potentially eligible participants will undergo a number of screening assessments, and each case will be reviewed by a central team of neurologist involved in the study. This is to ensure that patients only take part in the trial, and receive the trial treatment(s), if it is right for them and their condition.

You can check your eligibility for the trial by completing the centrally held Eligibility Questionnaire.

Patients who feel they may be eligible, and would like to take part in the trial, must contact their treating neurologist.

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