B-cell Research/UK Rituximab Clinical Trial
Frequently Asked Questions
Here are some frequently asked questions about this project.
The links below provide more information when you click on them.
Independent confirmatory trials of the Norwegian results are crucial if rituximab is to be licensed for use in ME.
Further, a UK trial will help raise the profile of ME in the UK as a disease demanding biomedical research.
And if an immune therapy such as rituximab is shown to be successful in treating the condition
it will help to re-affirm ME as a non-psychological disease.
This, in turn, will help to change public perception of ME, get better medical treatment for patients
and unlock the more funding for biomedical research.
The charity invited UK academic institutions to the BRMEC3 colloquium in May 2013 in order to gain interest in performing biomedical research which the charity wished to initiate. UCL expressed interest in assisting with this. After the BRMEC4 colloqium some work was performed to scope a trial. After discussions with UCL it was decided to perform a preliminary study to identify likely responders using the work of Dr Amolak Bansal as a basis. This has been decided to be performed by the UCL research team. The charity agreed to fund associated and complementary B-cell research at UCL with a PhD student. This allowed futher research to be performed which would add to the total knowledgebase and allow more confidence in the ability to determine likely responders. After this work is completed then a clinical trial protocol has to be established in order for the trial to take place. Applications to perform this resultant trial were advertised on our web site and interest was shown from UEA/IFR.
As more work has been performed on scoping a trial the charity was given an initial estimate that
the cost would be approximately £350,000. This could, of course, change as the initial
B-cell study and further research progresses.
Obviously, the more funding we have then the more flexibility there is in performing a trial.
Also reference should be made to the pages, here and on the Invest in ME Research website,
to the collaboration which has been, and is taking place with the researchers
in Haukeland University Hospital Bergen, Norway, where a Phase III trial is underway.
Our advisor, Professor Jonathan Edwards, proposed that the best approach is to set up a trial treating about 30 patients with a focus on trying to identify which patients are most likely to benefit from rituximab. Some further preliminary laboratory work is likely to be needed before it is clear what design would be optimal. We are guided by our advisors in this project and the aim is to get the most effective trial possible to help all people with ME.
Yes, it can and it will. Clinical trials by other groups are important and will provide the continuity and progress we
look for. The Invest in ME Research IIMEC7 conference of 2012 highlighted the case for clinical trials [R2].
Our advisor, Professor Edwards, has invaluable expertise to offer.
Invest in ME Research earlier arranged a visit to Bergen where Professor Edwards discussed with the Norwegian researchers
and discussing issues.
Further visits from the IiMER-funded UCL team took place - the collaboration with the Norwegian researchers,
and others, is underway and ongoing.
The Haukeland University team visited Norwich in January 2017 to discuss the trial.
Also, some may find the following attributed quote useful -
You could be missing a fantastic opportunity for that minority"
Rituximab has been used for other diseases over a long period. The researchers, clinicians and consultants involved in any trial will provide extensive information before involvement and the official ethical and regulatory processes will be performed by the research team and clinical trials unit, as per similar projects.
No - at the moment the best option is to perform clinical trials which will determine efficacy and safety for ME patients.
This is an option which is being considered by the the charity and advisors.
The preliminary B-cell study to find responders was based at University College London and was set up in collaboration with clinicians with expertise in ME from around London, in particular Dr Amolak Bansal. After advice from our Advisory Board and, in order to meet proper selection criteria, the clinical trial was made open for organisations to apply. After it was apparent, due to internal reorganisation, that UCL could not perform the trial then a decision was made to concentrate the trial in Norwich Research Park, with Quadram Institute Bioseience (formerly IFR) and UEA.
We are proud that Jonathan Edwards, Emeritus Professor of Connective
Tissue Medicine at University College London, has agreed to act as our
advisor. He raised the possibility that self-perpetuating
B lymphocytes drive human autoimmune disease in a 1999 paper in Immunology
and conducted the Phase I and ‘proof of concept’ Phase II studies of rituximab
for rheumatoid arthritis published in the prestigious New England Journal of
Medicine in 2004 that established the role of B cell depletion in autoimmune disorders.
You can read his statement on the UK ME rituximab trial here.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2326840/ http://www.nejm.org/doi/full/10.1056/NEJMoa032534 http://www.investinme.org/Rituximab%20news-July13%2001.htm
The UCL collaborated with Dr Amolak Bansal, who is the consultant immunologist and founder of the CFS service at St Helier Hospital and Dr Berkowitz (UCLH CFS clinic). The supervisors in Norwich Research Park are Professors Tom Wileman and Simon Carding. The team is also working in close liaison with the Norwegian researchers in Bergen where a Phase III trial is underway. The teams are in regular communication and have been in discussion in the Invest in ME Research Biomedical Research into ME Colloquiums and international conferences. This collaboration will undoubtedly help both the Norwegian and the UK studies.
Invest in ME Research has run an annual international biomedical research conference on ME every year since 2006, now attended by representatives from most of the world’s main biomedical ME research teams. The charity has also initiated a pre-conference Biomedical Research into ME Research Colloquium to foster collaboration amongst researchers, including a 2012 meeting on autoimmunity in collaboration with the Alison Hunter Memorial Foundation of Australia. Autoimmunity is, of course, an important aspect of the possible mechanism of rituximab in ME. The Colloquiums have become larger every year and in 2016 BRMEC6 had over sixty researchers from fourteen countries attending. We have drawn on our contacts with the international ME research community, including our European ME Alliance partners, to begin planning our UK trial.
We aim to raise the funds with the help of our supporters in Let's Do It for ME
and anyone who shares our objectives for the study and have always welcomed support from groups, organisations and individuals to raising
The charity reached out to other organisations early on in the project and invited them to support our trial - both with publicity and with funding or pledges. In return the charity would acknowledge the support and keep all informed of progress on a regular basis.
For those who feel they need to review our project proposal further they may organise their own peer review process, as they deem necessary. We welcome contributions from other organisations, companies, groups and individuals and will fully recognise any support given to us. A number of organisations have already helped us with donations and pledges and also via publicising the project- see here
Yes. We have created a separate, ring-fenced fund and account details are provided on the Donate Page on this site.
In Norway, Dr Maria Gjerpe, a fully-recovered patient from Dr Fluge and Professor Mella’s pilot rituximab trial, set up the MEandYou Foundation and raised £280,000 for the confirmatory trial in only three months. Maria gained such a public profile for the trial that the government provided enough extra funding for the trial to begin. The UK has many more people with ME than Norway and our initial trial will be smaller. The sum needed is less than that given recently by the MRC to researchers performing research in other areas connected to ME. Update: In February 2015 the announcement was made of the £1/2 million of research funding having been reached by IiMER supporters - click here. The support of many people around the world has made this possible. The Let's Do It For ME campaign has been instrumental in the positive campaigning and crowdfunding that has acheived this - click here
We are confident that the trial will go ahead but realise that it is important to be transparent about what will happen to the donated funds in the unlikely event that the rituximab project does not proceed. In such a case, the funds raised will be transferred to the Invest in ME Biomedical Research Fund to fund other biomedical research into ME projects initiated by the charity and within our UK Centre of Excellence for ME.. This has been stated from the outset.
If more funds are received than are required for a rituximab trial then the excess funds raised will be used for the rituximab project to increase the capability of the trial or go toward related biomedical research.
We welcome your support in the form of donating, fundraising, spreading word of the project, or simply letting us know that you are behind us in this effort. We need to raise awareness and interest from as many sources as possible.
There is still a lot of work to be done before the trial is at a participant recruitment stage. A trial protocol needs to be designed and ethical approval obtained etc. These things take time. The patients would be selected via normal NHS referral pathways. Consultants involved in selecting the patients for the preliminary B-cell study are based at the Epsom and St Helier CFS clinic and at the UCLH CFS clinic in London. In order to have a chance of being selected for the preliminary B-cell study one would need to be an existing patient at these clinics or be referred there as a normal NHS ME patient (not just for the purpose of the trial). The actual clinical trial has not started yet and we are still fundraising to ensure we have sufficient contingency. We would ask patients interested in any of the research funded by IiME not to contact the research teams directly as this inhibits their work and there is little they can do to help. Invest in ME will be happy to answer questions on the research and status and direct people to the correct pathway. The charity is not involved in the recruitment of patients in any research it funds as the ethics rules allow patient recruitment by the named consultant/s only. However, the charity does request that patients involved in the research projects should be properly diagnosed using current criteria (at least Canadian), that severely affected patients are also considered for participation when appropriate, and that the research is on myalgic encephalomyelitis (ME - although ME/CFS is sometimes used to standardise on the term used in the CCG). We have always built the strategy for developing services and research on the view that all treatments should eventually be available for all – and, in the UK, that means within the NHS. Also it would be advisable for any patients who wish to enter clinical trials not to view them as personalised treatment but rather look at the bigger picture and see this trial as helping progress the research into ME. At the moment the consultants involved in Invest in ME funded research (gut microbiota, B-cell study leading to rituximab trial) are Dr Bansal (Epsom and St Helier CFS clinic) and Dr Berkowitz (UCLH CFS clinic). The easiest way to be considered for any of the research would therefore be to get a referral to these doctors - but one should not be referred for research purposes only as the researchers want everything to be as unbiased as possible. The initial B-cell work being performed at UCL has been focusing on identifying patients that would be likely responders to rituximab. The UCL team have been working closely with the Norwegians to jointly understand the pathomechanism. In fact, the Norwegians specifically asked the UCL team to concentrate on just that and the charity has facilitated and worked for this collaboration. This cooperation helps both teams as well as all patients in the end and continues. So the trial will be determined on this research. The researchers are very thorough and careful and want to be as certain as possible that they can identify an objective way of selecting patients. So there is still time for patients to be selected in a future trial – but, as mentioned above, it isn’t for the charity to decide. The fundraising for the rituximab project and associated B-cell research is ongoing.
Rituximab is a monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys the B cells and so is used in autoimmune disorders, in which B cells play a role. Rituximab is also known by its trade names, Rituxan and MabThera.
We will update this page with information about the trial as soon as it becomes available but if you have something you want to know but do not find it here then please email us at email@example.com. We will also accept questions using an interface on this site - click here
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Thank you for your interest in the Invest in ME Research.
- Address: Invest in ME Research, PO Box 561, Eastleigh, SO50 0GQ, Hampshire UK
- Phone: 02380 643736 or 07759 349743
- Fax: 02380 000040
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