Rituximab Clinical Trial and B-cell Studies

Invest in ME is a UK charity campaigning for a strategy of biomedical research into Myalgic Encephalomyelitis (ME) and promoting better education about ME.

The UK rituximab trial project and related B-cell study research is a study which Invest in ME has initiated and has been organising since the international biomedical researchers meeting and conference which the charity organised on 30/31 May 2013 and which was announced on Invest in ME website on 6th June. 

They are doing this to further advance biomedical research into ME and provide hope for some to regain their lives, and for others to benefit from improved knowledge about this disease.

Background

At their 2011 Invest in ME international conference, Norwegian cancer specialists Dr Øystein Fluge and Professor Olav Mella announced strikingly successful results in their pilot study of the immunotherapy drug Rituximab on ME/CFS patients. In that study [R1] 67% of ME/CFS patients had moderate to major improvement, compared to only 13% of controls.

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The pattern of response indicated that ME may have an autoimmune component because rituximab works by temporarily wiping out immune-system B cells, which are implicated in autoimmune disease.

These groundbreaking results gained international attention when the study was published. In Germany, Professor Carmen Scheibenbogen is already looking at possibilities for a rituximab trial and in the US, Dr Andreas Kogelnik’s Open Medicine Institute is raising funds for a study. Dr Fluge and Professor Mella are beginning a confirmatory trial in January 2014, part-funded by the Norwegian government; at our 2013 conference, they presented further evidence of the efficacy of rituximab in the treatment of ME patients.

Multiple confirmatory trials are crucial because without evidence on safety and efficacy from independent studies in several locations, regulatory bodies will not approve or license rituximab for use in ME.

Invest in ME believe that the UK needs a rituximab trial, both to benefit UK patients and to support the international effort.

At the 2012 Invest in ME international ME conference IiME announced they were looking into starting a rituximab trial in the UK. From the time of the 2012 conference they have spent a year working on that idea as part of their efforts in setting up a UK examination and research facility for ME in Norwich.

They contacted universities throughout the UK in an attempt at raising interest for biomedical research into ME and for a clinical trial of rituximab for ME patients. They invited many to their BRMEC3 colloquium in London in May 2013. From that meeting the researchers from UCL expressed interest in the idea and agreed to work on helping this project.

On 6 June 2013, they announced that they were initiating a UK rituximab trial and began fundraising for it.

Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL), has agreed to advise them on all aspects of the trial. He is known worldwide for his work in B cell immunology and as lead researcher in the clinical trials of Rituximab for rheumatoid arthritis. No UK expert is better placed than Professor Edwards to advise on setting up a rituximab trial for ME patients.

The preliminary trial for this project will take place at UCL, led by Dr Jo Cambridge. It will be conducted by the same team that carried out the rituximab research in rheumatoid arthritis and who have considerable laboratory expertise in B cell immunology. This is the best possible team in the UK to carry out this work and they are confident that they can make this happen quickly.

All that remains to do is to fund the trial so that it can start as soon as possible.

 

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