1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Ergonomics and ME/CFS: Have You Hurt Yourself Without Knowing It?
Having a chronic illness like ME/CFS can make it hard to avoid problems that come from bad ergonomics. Jody Smith has learned some lessons the hard way ...
Discuss the article on the Forums.

Norwegian rituximab study to start 2014

Discussion in 'General ME/CFS News' started by Ninan, Dec 5, 2013.

  1. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    http://mariasmetode.no/2013/11/update-haukeland-english/

    12 fresh millions for the Rituximab study

    The Stoltenberg administration (the former Government) did propose a continuation of the economic support to the studies of CFS/ME by Helse Vest. Helse Vest have been granted funds for a national clinical multi centre study of CFS/ME both in 2012 and 2013. The proposal is to continue the support pursuant to cap. 781, post 79. This is understood to imply that the two millions that are now granted by the government budget are for the Rituximab study at Haukeland Hospital, as the four millions that have been granted over the government budget at an earlier stage. There are no comments or signals that indicates otherwise. This means that in total six million NOK have been granted over the government budget.

    Last week, the news was out that The Research Council had finally decided the spesific number of their contribution to be 10 million NOK. That means that it´s now 19 million NOK for the multi center Rituximab-study. 10 from The Research Council, 3 from MEandYou and 6 through the governmental budget.

    Multi center study
    The coming study is a multi center study. This means that several centers will, in accordance to a common protocol, treat a predetermined number of patients with Rituximab to study the effect. The datas with the results will be collected and treated at one location, with the participation of, and transparent to, all participating centers

    Where will the studies take place?
    As of today there are five centers that each will be in charge of a group of patients. Who will be part of the groups, and how many patients at each location, have not been decided yet. The locations are Oslo, Trondheim, Notodden, Tromsø and Bergen

    When will the studies start?
    When the studies will start at the various locations have not as of today been decided, but most probably during spring 2014. The researchers are in contact with each other and are doing the final work on the protocol for the study, in addition Forskningsrådet have not yet decided on how much their contribution to the study will be

    What is a protocol?
    A protocol describes in minute detail how the study is to be carried out. That the protocol is thorough and closes any holes that can be questioned at a later time are of uttermost importance. This takes time – but it pays to wait a bit extra to achieve a solid study that produces valid results

    How many have applied to take part?
    Don´t write more letters! We have received more than a thousand letters and referrals. So many, that it have been impossible for the researchers to reply individually. Your letter has been read even if you have not received a reply. All applications have been read, roughly classified by region, and will be forwarded to the nearest of 5 institutions

    How many patients are needed?
    It looks like 144 of this 100 will participate in the study. Half of these will receive medication, and the other half salty water (this is called placebo).

    Who will be selected?
    The decision is made by the institution as long as it is within the numbers that have been agreed upon. All the selected patients have to qualify according to the Canadian criteria, and have to be residents of Norway. Patients that have received Rituximab at an earlier time can not take part in the study. Although all the patients will be Norwegians, the results and knowledge found in this study, will be of benefit for both patients and doctors abroad.

    What happens with those participiants who do not receive medication?
    Half of the participants will not receive medication, but a small dose of salt water. This has no effect on the disease itself. At the same time we know that ME, over time in some patients, will improve without treatment. We want to control for this effect by the use of a placebo group in the study. If it turns out, after the study have been analyzed, that Rituximab have effect, and the cost of medications can be covered. those who received salt water will get Rituximab, possibly in a new study. That may only take place when the current planned study have been done and analyzed. This might take three years

    How will I know if I have been selected?
    Those who might be candidates will be contacted when the day of selection approaches. Then you will be called in for a pre-examination, then you will be notified whether you are selected or not

    Do we need more studies after this?
    For a medication to be approved for the use for a specific disease the use must be approved by «legemiddelverket» in Norway, and/or FDA in the US. If the result of this study turns out positive Rituximab will be much closer to approval. Whether the study is enough depends on the quality of the protocol – and consequently how reliable the result is. This is one of the reasons for the time and work spent on the reliability of the protocol.

    How much time before we might receive treatment with Rituximab?
    First all the patients have to go through the study, this will take two years starting when the last patient is included. All data will then have to be controlled, analyzed and published. FDA and the Norwegian «Legemiddelverket» will evaluate the data and decide wether there may be a new indication for Rituximab. This will at least take 4 years, possibly more. Rituximab will certainly not be a medication for all ME patients. As with any kind of illness or condition it is probable that different ME patients need different kind of treatments and medication

    Work is done on symptom directed treatment
    Do not despair! The researchers are aware of how horribly ill patiens are and how difficult life is for ME patients. Intense work is done paralell to the rituximab study to find symptom directed treatment for the patients as patients. Several different medications are being tried.
     
    ibenagnes, rosie26, L'engle and 9 others like this.
  2. WillowJ

    WillowJ Senior Member

    Messages:
    3,105
    Likes:
    2,735
    WA, USA
    that's exciting!

    however, saline is not placebo in ME.
     
  3. lnester7

    lnester7 Seven

    Messages:
    1,244
    Likes:
    1,123
    USA
    HOLLY C! good point, giving me Saline once a month would be enough to improve like 3 to 4 points for me!!!! Even though they say a small doses. If it is a few CCs might be ok.
     
  4. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    Saline once a month does nothing for me or anyone of the ones I know who have tried it. Dr Bell says so too. Must be at least three times a week to make any difference for me. There are probably exceptions but for most PWME:s the dose they give shouldn't make a difference.

    And yes, it's great news! :)
     
    L'engle and Purple like this.
  5. CBS

    CBS Senior Member

    Messages:
    1,367
    Likes:
    271
    Western US
    Glad to see this moving forward. I agree that saline in ME patients is not a placebo. Whether or not it would effect results will depend upon the amount of fluid given and the timing of functional testing and collecting reported activity/symptoms relative to the time of the infusion.
     
    knackers323, Purple and WillowJ like this.
  6. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    Since the amount of fluid given should be the same in both groups there shouldn't be a difference in response. The researchers are aware if it so I can't see it distorting the trial in any major way. There is no alternative, that I can think of, anyway.

    Anyway, we're up for at least six years of waiting. I hope that Roche and the others are pickning up and doing their own trials when they develop the successors of Mabthera. There are many new meds like it coming.
     
    Valentijn likes this.
  7. CBS

    CBS Senior Member

    Messages:
    1,367
    Likes:
    271
    Western US
    I agree that there may be no suitable alternative to using a saline based placebo but I'm less comfortable assuming that there is no potential for significant issues with doing so. Comparisons between groups should remain valid but comparisons to baseline may dismiss some degree of improvement as "regression to the mean" if saline used as a placebo has a therapeutic effect. This is where good design and awareness of potential issues become essential.
     
    Last edited: Dec 5, 2013
    WillowJ likes this.
  8. alex3619

    alex3619 Senior Member

    Messages:
    7,501
    Likes:
    12,000
    Logan, Queensland, Australia
    Lets look at it this way. Saline is mildly to moderately beneficial. Using that as the control means if they get successful results then they would be really good results. If however Rituximab gets dismal results, it will help to discredit the research. I do not think this likely however, from all reports the phase 2 trials were quite successful.

    They don't have many choices however. They need to deliver a liquid control comparison. They cannot use just distilled water as it might induce electrolyte problems. Saline is about the best they can do I suspect.
     
  9. Legendrew

    Legendrew Content team

    Messages:
    535
    Likes:
    692
    UK
    Exactly - criticizing the use of saline as a control is fairly ridiculous, more questions would be raised if it wasn't, given that saline is the standard control in medical trials of this nature. I admit that saline may be slightly beneficial for those who suffer low blood pressure and have ME associated with POTS or OI, however, if anything but saline was used I suspect it would be picked up on and used to criticize the design of the trial.

    That said I look forward to the results of this trial in a few years time!
     
    Valentijn and Ninan like this.
  10. aimossy

    aimossy Senior Member

    Messages:
    2,519
    Likes:
    3,194
    NZ
    All I can say is thankyou Norway and YAY.
    This could turn out to be the turning point in ME history....I hate to think what if they thought nah lets not bother about this thing that was noticed.....how much longer could we have been waiting for this to have perked doctors interest......fingers crossed and another YAY.
     
    rosie26, heapsreal and Ninan like this.
  11. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    7,320
    Likes:
    4,678
    australia (brisbane)
    Any improvements from the saline would be short lived anyway. im guessing the rituximab infusions are given weeks or months apart. for saline to have an affect one would need saline infusions atleast twice a week??
     
    Battery Muncher and WillowJ like this.
  12. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    I wonder which other meds are being tried. I would guess gammaglobulin is one of them. And they are using Enbrel for patients who don't respond to rituximab.
     
  13. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    Three times a week, in my case. Dr Bell says once a week makes one good day and six bad days.
     
    L'engle, merylg and heapsreal like this.
  14. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,527
    Likes:
    9,673
    Amersfoort, Netherlands
    Saline is an appropriate placebo. Rituximab is given as an IV fluid from what I understand, so the results patients experience are from the drug + the fluid increase. By just doing a fluid increase in controls, it's accounting for the effect of the fluid increase in Rituximab. Thus the actual improvement due solely to the drug can then be determined.
     
  15. Bob

    Bob

    Messages:
    8,595
    Likes:
    11,524
    South of England
  16. Firestormm

    Firestormm Guest

    Messages:
    5,824
    Likes:
    5,977
    Cornwall England
    Good to see them trying to come up with an objective way of measuring (I presume) functional ability before, during, and after treatment with the drug or placebo. Looks like they are now hoping to begin the Trial at the start of May.
     
    Bob, Svenja and Valentijn like this.
  17. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    From what I've read (I'm Swedish so I read Norwegian) they seem to be pretty ambitious. They know they'll be scrutinized, big time, whatever the result.
     
    Last edited: Jan 22, 2014
    Purple, Svenja and Firestormm like this.
  18. Firestormm

    Firestormm Guest

    Messages:
    5,824
    Likes:
    5,977
    Cornwall England
    I am of the opinion that fair scrutiny is needed. I want all ME research to be put under the microscope so that there can be no doubts. I recall well the 'arguments' put forth in the comments on PLOSONE I think it was when the orginal study was published. The Norwegian doctors were excellent in their rebuttal. My fingers are crossed that this forethought with regards to outcome measures means a better all round result for the study.
     
    aimossy, Snow Leopard, Bob and 2 others like this.
  19. Persimmon

    Persimmon Senior Member

    Messages:
    114
    Likes:
    132
    They're using the CCC!

    When Fluge & Mella conducted their initial blinded RCT, they used Fukuda.

    Possibly the decision to use CCC this time is driven by ethical constraints - who would sit on the ethics board and risk approving the administration of Rituximab, a potentially deadly drug, to fatigued individuals who don't have a disease?

    Another possible motivation for the change is that CCC presumably gives Fluge & Mella a better chance of clear-cut positive results.

    A third possiblility is quality control. No doubt Fluge and Mella selected patients carefully in their prior studies - picking genuine ME patients from among those who met Fukuda. This time, each trial centre is to independantly assess potential participants within its geographic catchment area. Using CCC would give Fluge and Mella a greater assurance that all the study centres will be selecting suitable cohorts.

    Whatever their reasons, they are voting with they're feet and bypassing the HHS/IOM circus!
     
    NK17, Ninan and Valentijn like this.
  20. Ninan

    Ninan Senior Member

    Messages:
    256
    Likes:
    195
    As I understand it, using Fukada the first time was a mistake due to lack of knowledge. They later went back and checked how many of the patients also fulfilled the CCC/ICC.
     

See more popular forum discussions.

Share This Page