Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Neurology, Mater Hospital Brisbane, Brisbane, Australia
Review Article
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
Author(s): 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 and 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 t.. View More»
DOI:
10.35248/2167-0870.23.13.528