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Clinical Trials for ME



The Invest in ME UK Rituximab Clinical Trial and B-cell Studies


Welcome to the UK rituximab trial Home page

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

This website describes the UK rituximab trial project and related B-cell study research 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.
We 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.


“Looking at the research directions currently being pursued in ME/CFS, I am in no doubt that the usage of rituximab is one of the most promising.”

- Emeritus Professor Jonathan Edwards


 “Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK.”

- Professor Malcolm Hooper & Margaret Williams


Read more in the paragraphs below or use the links in the table to go directly to an area of interest.



At our 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.

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 was already looking at possibilities for a rituximab trial and in the US, Dr Andreas Kogelnik’s Open Medicine Institute was 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.


We believe that the UK needs a rituximab trial, both to benefit UK patients and to support the international effort. With your help, we can make this happen.

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

We 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. We invited many to our 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, we announced that we 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 us 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 us on setting up a rituximab trial for ME patients.

You can read his statement on the trial here.


The preliminary B-cell study for this project has started and is ongoing at UCL. 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 we are confident that we can make this happen quickly.


The fundraising continues for this project and the current status can be seen here (see Donate to Trial by clicking on the link to the right).

More detail about the trial is given in our FAQs and News sections using the buttons to the right.


We invite you to support us in this great venture.


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Our Plan

Our proposal for an examination and research facility for ME [R5] included a national strategy of translational biomedical research. The university is now preparing to begin the foundation project [R6].

The UK rituximab trial fits into this strategy perfectly.

Please read our announcement (click here) as well as the news items to follow the progress of this project.


Invest in ME aim to build a fund to accomplish this ourselves but we recognise this is a huge task and therefore are happy to accept support and donations from others who have the same objectives as Invest in ME.

IiME are also discussing with our EMEA colleagues on ways to increase biomedical research into ME.

We are confident that projects being planned and funded by Invest in ME can make a real difference in treatment for ME patients.



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