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Study Protocol for a Phase II/III, Randomised, Placebo-Controlled Clinical Trial of Reducing the Frequency of Autoimmune Adverse Events in the Treatment of Multiple Sclerosis with Alemtuzumab using B Cell Depletion: The RAMBLE Trial

Michelle Ntiamoah, Chris Camarda, Chloey Osborne, Sofia Jimenez Sanchez, Fiona Marple-Clark, Victoria Cottam, Michelle Prosser, Rebecca Ward, Sin Hong Chew, Kayla Ward, Simon Arnett, Laura Clarke, Joshua Barton , Mike Boggild, Andrew Swayne, Stefan Blum, Zara Ioannides, Pamela A McCombe, Helmut Butzkueven, Michael Levy, Simon A Broadley

Monoclonal antibodies such as alemtuzumab are used for treatment of Multiple Sclerosis (MS) due to their high specificity and efficacy. Whilst highly effective, alemtuzumab causes autoimmune adverse events. A recent phase I clinical trial of rituximab therapy administered whenever B cell counts reached 50% of baseline levels following treatment of MS with alemtuzumab demonstrated a promising safety and efficacy profile.

The Reducing the frequency of Autoimmune adverse events in the treatment of Multiple sclerosis with alemtuzumab using B celL dEpletion (RAMBLE) trial is a phase II/III, randomised, placebo-controlled, multi-centre clinical trial conducted at five sites in Queensland, Australia. The investigational product, rituximab, is a monoclonal antibody against CD20. The study will recruit 80 people aged 18 to 55 years who have been diagnosed with MS in the last 10 years and meet outlined inclusion and exclusion criteria.

The primary objective is to demonstrate a reduction of the occurrence of autoimmune disease with administration of rituximab following treatment with alemtuzumab for MS by measuring autoimmune adverse events including thyroid disease, idiopathic thrombocytopenia and anti-GBM renal disease. The secondary objectives are to assess the safety and efficacy of this therapeutic approach as well as assess the profile of the immune repertoire of T and B cells that re-emerges.