A review of recruitment characteristics of StarMS (ISRCTN88667898), the first clinical trial to randomise patients with treatment naïve rapidly evolving severe Multiple Sclerosis (RES-MS), or active relapsing remitting MS (RRMS) despite disease modifying treatment (DMT), to autologous haematopoietic stem cell transplantation (aHSCT) or high efficacy DMTs.

aHSCT is an effective and safe treatment resulting in suppression of disease activity and delay of disease progression in patients with RRMS who fail first line DMT. Safety and effectiveness compared to high efficacy DMTs or its role in the treatment of patients with aggressive MS remains undetermined. 

Star-MS is a multicentre parallel-group rater-blinded randomised controlled trial of aHSCT versus DMT (alemtuzumab, cladribine, ocrelizumab and ofatumumab) of 104 RRMS patients in the United Kingdom. aHSCT is delivered using non-myeloablative conditioning with a cyclophosphamide/anti-thymocyte globulin regimen followed by an unselected autologous graft.

Inclusion criteria consist of active RRMS defined as ≥1 relapse or evidence of magnetic resonance imaging (MRI) disease activity in the last 12 months despite DMT, or treatment naïve RES-MS defined as ≥2 disabling relapses in 12 months, and ≥1 gadolinium-enhancing (Gd+) lesions or a significant increase in T2 lesions on brain MRI.

Star-MS commenced recruitment in September 2021. By October 2023, 51 patients have been randomised, 76.5% are female, 35% have treatment naïve RES-MS and 65% have active RRMS despite a mean of 1.3 DMTs. Median EDSS is 3 (0-6). In the 12 months prior a mean of 2 relapses occurred; 1.7 for patients on DMT and 2.5 for those treatment naïve, and a mean of 1.2 vs 1.3 new T2 and 0.36 vs 1.1 Gd+ lesions, respectively.

StarMS will provide class 1 evidence of the best treatment strategy for patients with aggressive MS thereby enabling future delivery of appropriate treatments early in the disease course when they may be most effective.