How likely is a UK rituximab trial?

[Jo Best]

Just to add that the UK rituximab research (including the B cell studies) may be best viewed within the context of the Invest in ME Research Centre of Excellence for ME translational biomedical research strategy. The UK researchers are working steadfastly to join the dots in this complex disease in productive collaboration with other researchers in Europe and around the world. At the 2016 Invest in ME Conference, Professor Simon Carding mentioned these areas in his presentation -

1) Infectious origin
a) environment
b) microbiome alterations

2) Clinical trials
a) Rituximab
b) Bacteria based therapy

In a statement in July 2013 (after he had kindly agreed to advise IiMER on a UK rituximab trial) Professor Jonathan Edwards said -

My interest in ME/CFS was sparked when I was invited, unexpectedly, by IiME to the IiMEC8 Conference in May.

The meeting was impressive: not just professional science, but at a high level. I was particularly impressed that negative findings were given adequate weight. (my bold)

It became clear to me that there was a community committed to identifying and encouraging the very best research in a difficult and neglected field.

I think this has been an important part of the process to date; that these researchers value their own negative findings and use these to proceed to next steps.

I wondered if you'd seen the link about the visit by Dr. Fluge and members of his team to Norwich in January -
http://future.cofeforme.eu/ce-news-1611-02.shtml

 

[Jo Best]

p.s. for anyone wanting to see how this has been progressing since June 2013, this is the news page on the IiMER UK Rituximab Research microsite - http://www.ukrituximabtrial.org/IIMEUKRT News.htm

 

[FTY]

Great post @Jo Best , much appreciated

 

[Jo Best]

Thank you @FTY and for flagging up the first news link

 

[Jo Best]

Info on the January 2017 meeting at Norwich Research Park posted by IFR today - http://www.ifr.ac.uk/news/events/2017/01/mecfs-biomedical-research/
Extract -

Dr Fluge is visiting Norwich to collaborate over another Rituximab trial being carried out on the Norwich Research Park. Professor Simon Carding from the Institute of Food Research (IFR) and University of East Anglia will also be talking about at the event about this, as well as research in his own group, who are looking for causes and treatments for ME in the gut and its microbial communities. The Norwich Research Park is establishing itself as a hub for biomedical research into ME, in the UK and Europe and through international collaborations.

After the talks there will be a panel discussion with a chance to ask questions from the speakers.

The event is being hosted by IFR and Invest in ME Research, a charity promoting biomedical research and education into ME, which is aiming to establish a UK centre of excellence, to improve ME diagnosis and coordinate research into treatments and cures. http://www.ifr.ac.uk/news/events/2017/01/mecfs-biomedical-research/

 

[Jo Best]

New Year summary on Let's Do It for ME blog - http://ldifme.org/2017/01/03/from-norway-to-norwich-iimer-rituximab-research/

 

[FTY]

@Jo Best thanks for keeping us updated on this. Do you have any idea if the talk will be recorded?

 

[Jo Best]

@Jo Best thanks for keeping us updated on this. Do you have any idea if the talk will be recorded?

Sorry for the delay in returning to this thread. I've not seen anything about recording arrangements but they posted the agenda for the evening talks - http://www.investinme.org/ce-news-1611-04.shtml

 

[justy]

I you scroll down on the agenda page to the bottom there are some funding circles showing how much has been raised for each project. The B cell/Ritux trial is at 96.2% of the funding needed.

This is the home page for the UK Ritux trial /Invest in ME

http://www.ukrituximabtrial.org/home.htm

 

[Jo Best]

@Jo Best thanks for keeping us updated on this. Do you have any idea if the talk will be recorded?

Just spotted this comment by IiMER on facebook - "We arranged with IFR to film the event. This should be available soon". And IFR updated their events page - "Thanks to everyone who came to our public talks in Norwich on biomedical research into ME/CFS on Thursday 26th January. Look out for a report on the event soon".
http://www.ifr.ac.uk/news/events/2017/01/mecfs-biomedical-research/

 

[FTY]

@Jo Best Thank you! I don't use facebook, will you alert us here when it is available? Thanks

 

[Jo Best]

@FTY will do meanwhile, I expect you've seen the links to the BBC Look East TV news report, but here are the links. The late evening news included a studio interview with Prof Simon Carding and if you're in UK or can access the BBC site, it's here for a few days (would be good to gets lots of views) - http://www.bbc.co.uk/iplayer/episode/b08bbztq/look-east-late-news-26012017

After that, or for those outside UK, this is the early evening news report -
https://m.youtube.com/watch?v=tF3jZWVc8F8&feature=youtu.be

And the studio interview -

 

[FTY]

@Jo Best Thank you!

 

[Jo Best]

The video of the public talks was added to the page with the links to both youtube clips of the BBC Look East TV news reports - http://www.investinme.org/IIME-Newslet-1701-02.shtml

 

[Jill]

Is there any more news on when the uk trial might start ? Just had a rhematologist say yes he'd help and be our prescribing physician , only to be told on Thursday that he'd pulled out. How on earth are we to get physicians to help by publishing cases when physicians are too frit to try it. Frit of being struck off we were told . The hoops we jump thru is ridiculous . If Al gets lymphoma tommorrow we will only agree to treatment with rituxan if it's planned to continue supply for ME or he'll choose to die of lymphoma . we feel more than betrayed when these friggin Drs no nothinh of the illness ( why agree then not agree) just cruel .

 

[FTY]

Is there any more news on when the uk trial might start ? Just had a rhematologist say yes he'd help and be our prescribing physician , only to be told on Thursday that he'd pulled out. How on earth are we to get physicians to help by publishing cases when physicians are too frit to try it. Frit of being struck off we were told . The hoops we jump thru is ridiculous . If Al gets lymphoma tommorrow we will only agree to treatment with rituxan if it's planned to continue supply for ME or he'll choose to die of lymphoma . we feel more than betrayed when these friggin Drs no nothinh of the illness ( why agree then not agree) just cruel .

I know it is so frustrating and we're sick of waiting. I really feel for you. But, at the same time, I think that your Doctor should be struck off if he starts giving rituximab to patients at this stage - it's a powerful drug and so far there isn't enough evidence to show that it works. Plus even if there was it should only be prescribed by Drs with a lot of experience of using it. He was wrong to have promised to give it to you in the first place. He should be keeping up with all the research and talking this through with you when you see him, not making promises he can't keep.

Sorry if I've understood your position. I think a UK trial is still on the cards and results from phase 3 Norway trials will be out in 6 months so there is movement. Let's hang in there xx

 

[Jo Best]

Is there any more news on when the uk trial might start ? Just had a rhematologist say yes he'd help and be our prescribing physician , only to be told on Thursday that he'd pulled out. How on earth are we to get physicians to help by publishing cases when physicians are too frit to try it. Frit of being struck off we were told . The hoops we jump thru is ridiculous . If Al gets lymphoma tommorrow we will only agree to treatment with rituxan if it's planned to continue supply for ME or he'll choose to die of lymphoma . we feel more than betrayed when these friggin Drs no nothinh of the illness ( why agree then not agree) just cruel .

The researchers don't recommend rituximab for ME/CFS outside of the clinical trials as yet.
The UK trial is planned to start by the end of 2018 and the protocol will be informed by the results of the Phase 3 Norwegian trial (unblinded by September 2017 and published 2018) as far as I know.
There are clinical trials of other treatments either in progress (such as the Norwegian Cyclo-ME) or planned (such as bacterial-based therapies) and other possibilities such as the immune modulators.
I'm sorry that I don't know your situation but I strongly empathise with what you say.

 

[Jill]

Thanks for the update info . I do understand that it shouldn't be used out of clinical trials at this point and that should have been his reasoning and that is what I'd expected the rhematologist to say. The clinical director of the hospital had sent us to him because he had the most experience using it . He really wasn't up to speed and obviously politics have been at play - saying one thing to us then pulling out when talking to the clinical director . They had applied to our drug agency pharmac and got turned down ( which I guess they both knew would happen), then they were to apply to Roche. He must have pulled plug at that point. The clinical director was then stuck without a prescribing physician . He said he took the case to the ethics committee and they weren't happy about the hospital applying to Roche without a prescribing physician .
They both know al is on a knife edge. It's been a case of good cop bad cop and we've had to fall in with the good cop because currently he is Al's dr. Last year I'd made a major complaint to the hospital that there was know one who was up to date - I think we are proving this point rapidly . I have suggested ( in s talk I gave at grand rounds) that someone be sent to the invest in ME conference so patients can be seen by someone who is up to speed. I will continue sending info but it lands on deaf ears currently .

 

[Gingergrrl]

If Al gets lymphoma tommorrow we will only agree to treatment with rituxan if it's planned to continue supply for ME or he'll choose to die of lymphoma .

Is your husband (partner?) trying to get RTX for actual lymphoma but his doctor (or insurance) are denying it?!!! I am so sorry to hear this and hoping you can get it corrected soon.

 

[Jill]

Is your husband (partner?) trying to get RTX for actual lymphoma but his doctor (or insurance) are denying it?!!! I am so sorry to hear this and hoping you can get it corrected soon.

No not lymphoma . It's just we used that as an example of the lack of knowledge . Ie that if he did get lymphoma they would treat him , but without the promise of ongoing treatment for ME we would refuse treatment . It was a hypothetical example . Sorry about confusion .