12 June 2014: Norway Multi-Site Clinical Trial: Funding and Commencement Update

Firestormm

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Looks like the total funding for the mulit-site trial still has some way to go:

12 June 2014
Summer Appeal
http://me-forskning.no/sommer-appell/

The multisite study is still not fully funded.

The preparation for the multisite study of Rituximab and ME is in full swing, thanks to the sufficient funding to start up.

But the study is still not fully funded. This study is a great bet to find out about the highly promising
results from smaller studies can be confirmed.

Five centres in Norway and about 150 patients will participate in this double-blind, randomized and placebo-controlled study. The centers that will participate in the multisite study has received over a thousand inquiries from patients who are seeking to become research candidates.

These are chronically ill patients who would like to return once again to the community, only they are being given an opportunity. The research on the cancer Department at the Haukeland University Hospital has until now shown that two out of three ME-patients will get the response of the medication.

Never before has research on the medical treatment of the ME given so promising results.

A smaller study of Rituximab and ME will start up in England at University College London, as soon as the funding of the study are in place. The British organization Invest in ME is soon in the aim of their collection for the study.

The work of the scientists at the Haukeland generates that is both ME-research abroad and that Norway is put on the map as a research nation. For doctors, researchers, patients and relatives all over the world
have been famous Zurich and Munich and loved ones name.

The latest estimate from Haukeland University Hospital on the total expenses of the study was on the 27 million kroner [£2.6m or $4.5m].

Today there are around 20.5 million in the pot thanks to a large grant from the Norwegian Research Council, additional appropriations of State budgets as well as assets in the form of gifts and fund-raising activities.

Norway's ME-Association has to date contributed 1.5 million dollars through the annual campaign ME-research.


We should be proud that Norway through the Haukeland University Hospital is leading the way internationally in the biomedical research at the ME. It is surprising that further development has been delayed due to lack of funds despite repeated promises from several politicians to follow up onthe research.

Norway's ME-Association his fundraising is continuing efforts to provide the funding for biomedical research at the ME. Our main priority is the multisite study and the funds we collect will go tothis study until it is fully funded.

But we hope the State now helps with the last part of the funding so that our collection assets can go to other biomedical ME-research.

There remains a lot of work in research on ME. We look like that a lot more research projects initiated moving forward and that we have the opportunity to support these.

Political fundraising work for ME

Prime Minister Erna Solberg gave ME-the patients a video greeting on the international ME-day 12. May this spring. Here she told me among other things, that the funds are set aside in the next State budget to
research on ME.

We are very curious to know if this means that the multisite study will make a separate post on the next budget, and whether sufficient funds will be appropriated to that study eventually will be adequately funded.

Alternatively, that it will be given a guarantee that the annual extraspending of two million over the State budget, which has been given since2011, will continue even while the study is in progress and that the study full funded that way.

Or is it we patients and next of kin who have to collect the rest?

The situation in Norway has not changed much for ME-the patients since the Sintef's discouraging report from 2011 which concludes:

-There is lack of knowledge about ME in social, welfare and health services.A few municipalities have offers that caters to the needs of patients withME.

-More of the health authorities has not built up any specific offers to thepatients with ME.

-There is lack of agreement on and implementation of diagnostic criteriafor ME.

-There is lack of curative treatment of ME.

-There is lack of appropriate treatment, rehabilitation and human services offers for the worst acting with ME

-There is insufficient expertise and failure to offer when it comes to the special challenges related to children and young people with ME

This is not good enough.

Christian Democratic Party-politician Laila Dåvøy have for years engaged himself strongly in ME-the case.

As the opposition politician also marked the conservative party's Erna Solberg himself as spokesperson for the ME-patients.

The former Health Minister and newly-appointed party leader Jonas Gahr Støre from the Labor Party, provided the for a larger appropriation to the multisite study by the Norwegian Research Council.

In the work programme to the Environment Party the Greens it says:

"It is limited in the degree to which politicians can influence which research projects are granted funds to, but we have a strong desire for more funds for the ME-research, including Rituximab study in Bergen, Norway. Not only can the development of a treatment facilities help immensely many people back to life, it is also the direct socio-economic-so there is noeconomic arguments to continue neglecting this disease, so the situation goes a long way is today. "

On the team, we have also the SV-politician Audun Light ground. This blog post from may of this year.

Cheers to all and sundry who raise the voice to improve the situation forME-sick. We want to see ME-involvement of even more politicians and parties!

In Sweden, we have this spring set a bipartisan work for ME-the case.

We see a similar mobilization among Norwegian politicians to shed some light on and lift up one of the sickest patient groups in Norway that still stands without adequate health care?

Dear politicians; We have their support and fighting spirit in the fall during the budget negotiations? Are you going to stand United for a much-needed boost for ME-the patients in health care? We get to see earmarked spending on biomedical research, ME-Rituximab study in particular, and to a number of health services based on the current knowledge about the disease?

Please feel free to contact with Norway's ME-Association if you want to know more about ME-patients ' situation in Norway today and what the Association is fighting on the patients ' behalf.

We are here to play ball with you and the health care system for the best possible quote for ME-patients!
Thanks Tom for posting the translation on Co-Cure :)

Several recent posts indicate the Multi-site Trial is proceeding irrespective - presumably - of this funding shortfall. For example:

The Rituximab study in Norway is scheduled to begin in August.

Just received a letter from the doctor in charge at one of the hospitals. I have attached it, but it is in Norwegian. Here's my quick translation of the content:

To ****

Date: 28 May 2014

It is now just before a large multicenter study of Rituximab starts in Norway . Five hospitals will participate with a total of 144 patients. UNN ( Tromsø), St Olav ( Trondheim), Haukeland ( Bergen ) UUS ( Ullevål , Oslo) and Notodden hospital will all be a part of the multicenter research trial.

Notodden Hospital is responsible for patients which reside in Telemark, Vestfold and Buskerud (counties in Norway). If you live in Telemark / Vestfold / Buskerud and have already submitted an application or request to one of the five study centers, your papers sent to us. We will very soon send letters to the most appropriate patients. These will be called and invited to a in-depth conversation about the study. We will also send a message to those that didn't get in. A draw will decide between the many that are well suited for the study.

Requirements to join this study are many, including that you are aged over 18 and under 65, has been ill for at least two years but not more than 15 years. For those under 20 years of age the disease must have lasted five years . All who join the study must be well diagnosed with M.E. They can't have other serious illnesses that make them not withstand Rituximab, or making it difficult to assess whether the treatment is working. Pregnancy can be dangerous for the baby. Patients must be motivated to conduct the study in two years even if you do not know if you get active treatment or just a placebo (dummy treatment). There can be side effects, and you have participate in many different surveys and questionnaires throughout the period.

Notodden Hospital have had contact with over 150 patients who have a well diagnosed ME disease. We also received patient applications forwarded from Haukeland University Hospital for those living in "our " counties. If you have not been in contact with any of the study centers on this now, is it too late to apply for the study. We have more applicant than we are able to include. Notodden is responsible for 32 patients, of which only 16 will receive Rituximab, 16 will receive placebo (dummy treatment).

In autumn 2014 , we expect to start with feasibility studies and infusion of medications.

regards

Hanne Thürmer , MD
Chief Attending Physician
Medical Department Notodden Hospital

Ann Elin Lonar, Study Nurse
Medical Outpatient Clinic Notodden Hospital
And a further comment from a patient who spoke with Dr Mella at the recent Invest in ME conference in London:

From mecfsforums:

"I had a lengthy talk to Prof Olav Mella during the lunchtime break at the conference and was very impressed by him.

He said that the next stage in proving the efficacy of Rituximab is now ready to begin in the form of their multi-centre study involving a large number of Norwegian M.E. patients. http://me-forskning.no/english/what-is-happening-with-the-research-into-me-and-rituximab/

The treatment protocol involves multiple infusions - one infusion every 3 months - over a total two year treatment period. The study will not therefore be reporting for another 3 years yet...
"
 
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Imagine being told you were in the placebo group after 2 years!

If someone makes a big discovery in the pathophysiology of ME before this trail is published, which explains the positive effects of rituximab on the illness, would it then be possible for doctors to use the drug on an experimental basis at the least?
 

deleder2k

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I am still not sure I understand things correctly or that there isn't more than one Trial taking place... or that the total's raised aren't being used for different things...

Signed.

Perplexed of Cornwall :)
There will be one trial at 5 different hospitals in Norway. A so called "multi centre study, phase 3 study". n=154, i.e 154 patients. They still need a few quid short, but they don't expect that to be an issue. In August patients that are eligible to be a part of the study will be noticed. Tests and Rituximab/Placebo induction will commence early autumn.

Chronix: Patients that were in the last studied were promised Rituximab after the study was complete if they were given placebo. If the results as positive as the last studies, I think Rituximab could be used as a treatment.