Yesterday there was a press release from Roche announcing ORATORIO-HAND a new phase 3 trial in people with PPMS, but only this time recruitment will extend beyond EDSS 6.0 up to EDSS 8.0, i.e. wheelchair users. The primary outcome will be the 9-hole peg test.
For people in the field of MS, the announcement of the ORATORIO-HAND trial represents a milestone in the history of MS. It challenges the dogma that once you have more advanced MS (progressive disease) that you are ‘irredeemable’ and sends a message of hope to all people with MS in wheelchairs that we haven’t forgotten you.
I hope that our long-running #ThinkHand campaign will play a part to play in getting the wider MS community and other relevant stakeholders behind this study.
Please note that I have a new disclosure in that I will be the principal investigator on this study.
ProfG
Well done, all that lobbying is bearing fruit.
Where is this study happening? How d0 I get involved?
It will be an international trial with many centres involved. I am sure Barts-MS will be a site.
You have indicated that progressive MS is a natural and logical progression of RRMS. Roche are using Ocrevius in a ground breaking trial to see if it slows down development for people with advanced PPMS. Why are people with advanced SPMS being excluded?
This is great news indeed.The categories of PP vs SP MS are regulatory hoops through which compounds need to jump if they are to get/extend a license.And there is still room for innovation; why settle with the Moon if you can go to Mars – #ChariotMS will enroll participants with advanced MS regardless whether primary or secondary progressive, at EDSS 6.5-8.5. Let's hope it get's funded!
Re: "Why are people with advanced SPMS being excluded?"One word; Regulators. The regulators treat MS as three diseases and not one disease. They want a PPMS trial to be done.
lol. who convinced the regulators that MS is three diseases?
Why isn't sanof doing same trial using Alemtuzumab? Given it's the most effective treatment?
That is a very good question.
Maybe they will, but is it too late?
We will celebrate tonight. That is in Lisbon. We will have to another celebration when we get back to London next week.
Utterly brilliant – well done Prof. G. from pwMS. is the silence and lack of replies because the team are in the pub celebrating. So they should!
No pub time yet, just arrived in Lisbon for meeting of the European Academy of Neurology!
Google/android have sabbotaged me and have stopped me from being able tto comment.
Time to update the #thinkhand 3 billboards slideshow – great news
Re: "Time to update the #thinkhand 3 billboards slideshow …"Thanks. Done!
Hoping to make it 2 trials when we get #Chariot-MS funded.
Maybe revising the 3 billboards slides to include optimism woudl be good, by adding 'so far'? After all, those of us with MS need all the optimism we can get and this is already a massive step forwards. Hopefully the doors are now open for other trials and approvals down the line.
As someone with MS, I have a few questions please: is there any up-to-date news on the number of serious infections, deaths and rates of malignancies following use of Ocrelizumab in trials so far? Would it not be especially risky for more advanced patients, especially if they are of older age, to be taking repeated infusions with long-lasting B cell depletion? How sure can we be that it will be safe switching from other DMT's to Ocrelizumab and vice versa? I'm sure I've read somewhere that Ocrelizumab reduced the progression of brain atrophy very little? Thinking of relapsing patients treated with Rituximab whose disease still eventually worsened, is it really worth putting patients through so many unknown long-term risks on Ocrelizumab with potentially so little, if any, true benefit? I sincerely hope my concerns are unfounded and I really do hope this new trial proves successful. How soon before we can realistically see Neuroprotective drugs in use?
I wonder this myself. If SPMS is a consequence of years (decades) of a hostile CNS environment due to demyelination which causes eventual axonal loss (a previous post discussed managing expectation of a cure), why should Ocrevus be expected to work. Sometimes I think MS'ers are too complacent in buying the hype without looking at the reality of a new drug.
I think "MS'ers" are too complacent in buying the hype without looking at the reality of a new drug.Fixed It for ya…I think "Neuros" are too complacent in buying the hype without looking at the reality of a new drug.
I think of the AIDS crisis in the 80's. It wasn't the doctors who brought about revolution in treatment. It was the patients. HIV is now a manageable, non-fatal, condition for most. You didn't hear celebrities with AIDS say, "Stay Positive!" Or, "I have AIDS, AIDS doesn't have me." Perhaps I'm overly cynical, but I don't expect "Neuros," many of whom in my neck of the woods (the U.S) accept loads of money from Big Pharma, to lead the cavalry.
To the point Anon^
Brilliant news! Has quite made my weekend!Do hope you all celebrate and that at some date soon you can celebrate kicking off the Chariot-MS trial.
Grounds to celebrate – a paradigm shift in attitudes in treating people in the advanced stages of MS where stopping further deterioration is crucial to preserving (the remaining) quality of life. As a trial will this be restricted to pwMS who have not previously had DMT's, or will there be scope for those of us who have already started/had another treatment? I assume previous treatments might compromise/affect trial results so expect the answer would be no, but it'd be nice to know rather than giving false hope.
"a paradigm shift in attitudes in treating people in the advanced stages of MS where stopping further deterioration is crucial to preserving (the remaining) quality of life."Yeah sounds great just don't think there are therapies that can accomplish this..Just that the neuros don't like to admit it.This guy was on Rituximab and just continued to progress..progress..progress.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5221476/
Will be following with interest, think Vicky is past 8 on edss, but might apply and let someone else decide.Thanks for the info.Regards as always.
Hi Andy, Also looks like there's some significant moves on medicinal cannabis in the offing.
Hi MD2,Let's hope so, looks like Canada have stole a march on the rest of the developed world, we'll have to see if the British Government will allow adults to be adults, but it's a start and a welcomed step in the right direction. A link to applying to get on the above trial would be useful, think Vicky is too far progressed, but we never give up. She went down in weight as low as 4st 8 1/2 lb, BMI 11.5 Weighed by dietitian yesterday, drum roll !!!!!! 6 1/2 St 🙂 That's years after continual weight loss !!!!A few days pain free with the aid of cannabis and she could be on her way back, just like the England team ;-)Regards as always.
Mousedoctor 2: Please can we have some clarification about who can prescribe Satixex (medicinal cannabis oil) for pwMS and for exactly what symptoms? An insiders view would help many of us find reliable information about this. Hopefully the present high profile cases of NHS permitting cannabis oil for specific treatments will help reduce the social stigma of the medicine. Maybe a separate post as this is certainly topical right now.
At present Sativex is licensed for the treatment of spasticity associated with MS, not for any other indications and can be prescribed by your GP or neurologist. However, it's expensive and many health trusts will not fund it so as so often there's a post-code lottery.It will be interesting to see what the Home Office review comes up with regarding medicinal cannabis. GW pharma (makers of Sativex and another drug for epilepsy Epidiolex awaiting approval) won't be keen to see cannabis being approved for medicinal use as it will have a direct impact on their profits. For the conspiracy minded, apparently from what I've seen quoted,Theresa May's husband Philip's investment fund Capital Group is the largest investor in GW pharmaceuticals. Make of that what you will when the Home Office decision is reached.We'll have to wait and see what decision they come up with, my hopes aren't high but hopefully I'll be pleasantly surprised.
Many thanks Mousedoctor 2 – sad about the postcode lottery but not surprised by the latest conspiracy theory – maybe one for Private Eye before it happens.
There's plenty of reports on the conspiracy theory already, I'm sure Private Eye might be looking into it too.
It also appears that head of GW pharmaceuticals Geoffrey Guy donated ÂŁ50K to the Conservative party not sure when). The plot thickens!https://endpropaganda.wordpress.com/2017/08/07/donations-to-tory-party-largest-first/
At present Sativex is licensed for the treatment of spasticity associated with MSIn CA recreational use is legal..baclophen is imperfect.If one used regular marijuana would any benefit spasticityor is Sativex designed/modded better for spasticity..?
Brilliant news about the trial, how do I apply to participate in the trial?
Is this trial still recruiting? Is it feasible for someone with PPMS (diagnosed 1991) to be involved if they don’t live in London?
I’m relatively new to this debate. I think more could be done to raise awareness of this amongst MSers in order for them to bring more collective pressure to bear by challenging this with their own clinical teams. I find it an absolute nonsense that anyone needs a study to see that the criteria are outdated and prejudicial! I have been in a wheelchair for almost 2 years, SPMS. I am a single mum raising an autistic teenager, I cook, do laundry, arrange the online shopping, manage our finances, take my dog out on my scooter daily. I transfer unaided and wash/dress etc with no assistance. I am denied access to drug treatments that might prevent me losing use of my arms and so being unable to care for myself or my son. If I were blind, unable to speak, with no upper limb mobility and severe cognitive decline I would not be able to do any of the things I can now BUT would get the drugs. We don’t need studies and trials just some common sense. A 5 year old could understand this!