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Norwegian Rituximab study - An update by the Norwegian ME association 2014.11.09

Discussion in 'Rituximab: News and Research' started by deleder2k, Nov 7, 2014.

  1. deleder2k

    deleder2k Senior Member

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    The Norwegian ME posted this on their website a few hours ago. I translated it.


    Please see the attachment.
     

    Attached Files:

    Ellie_Finesse, mango, Wally and 21 others like this.
  2. aimossy

    aimossy Senior Member

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  3. ukxmrv

    ukxmrv Senior Member

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    "• Not any of the study centres are done including patients. Candidates are still being convened."
     
  4. xrunner

    xrunner Senior Member

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    Thanks @deleder2k, do you know how long approx. before any data/outcomes from the study will be made available?
     
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  5. Snow Leopard

    Snow Leopard Hibernating

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    We're looking at about 3 years before all the data is in and sorted. Maybe 2 years if they were to publish the 6-12 month followup data before publishing the long-term followup data.
     
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  6. deleder2k

    deleder2k Senior Member

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    I am not sure whether they will do that and then publish a follow up after 24 months. One GP told me that they could axe the study after 12 months if they results were very promising. In prior studies the effect with Rtx was seen after 2-7 months. If they halt it after 12 months one will not know whether they patients will relapse again which occured after phase 2. Any thoughts on this?
     
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  7. xrunner

    xrunner Senior Member

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    If results were very promising, ditching the study would be a shame but perhaps data on relapses could be gathered later from clinical practice, especially if this study would then open the door to treatment for patients.
    A successful study should in any case generate sufficient interest for further studies and most of all kick all the psychobabble arguments out of the window for good. This last possible outcome would be just on its own extremely good.
     
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  8. NK17

    NK17 Senior Member

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    Thank you so much @deleder2k for posting this document and everything else you've been doing to keep us updated.

    Norway rocks :thumbsup:
     
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  9. deleder2k

    deleder2k Senior Member

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    Not sure if it is interesting or not, but I thought someone might find it OK to read.
     
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  10. NK17

    NK17 Senior Member

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    To me is very useful, I'm going to forward it to my PCP and my gastroenterologist.
    I've been distributing hard copies of Mella's speech that you have uploaded to my doctors.
    Takk again ;).
     
  11. deleder2k

    deleder2k Senior Member

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    Oh? Not sure if that is wise. I am not exactly a certified translator.. haha
     
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  12. catly

    catly Senior Member

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    @deleder2k I find all of you updates very helpful and hopeful. Please keep updating us.
     
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  13. Freddy

    Freddy

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    Your translation is not that bad! (German way to praise some one)
    Thanks for your updates, very appreciated!
     
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  14. funkyqueen

    funkyqueen Senior Member

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    Thanks :)
     
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  15. Griffin

    Griffin

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    Am I being very silly, but if results are promising, isn't that an argument for completing follow up phases? I don't get why it would be a reason to axe it.
     
  16. deleder2k

    deleder2k Senior Member

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    I am not understand what the GP meant, but it could be that the effect should occur within 7 months with RTX. If one year elapsed, then they know who's responded to the drug and who didn't. They could still follow up those with response, but they would be unblinded... Guess it sounds smarter to do a 2 year study. It is better than a 1 year study. The problem could be that many will relapse after 2 years. I think 1 year from the last infusion to the end of the study is way to short to know how patients that will relapse.
     
  17. Griffin

    Griffin

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    Yes. I guess with a remitting-relapsing disease you actually need to follow up for many years. But as you say, it would be unblinded. But that is an issue with any long term follow-ups.
     
    deleder2k likes this.
  18. deleder2k

    deleder2k Senior Member

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    The question is whether unblinding the subjects after 1 year since first infusion is sufficient or not. No one have responded after 7 months, at least not in the double-blinded study. I wonder why they choose 2 years.. I guess that follow up for 24 months is better than 12 months. Too bad for 76 who will receive nothing but placebo. I guess they will continue to follow up the patients after the study is ended. Information about relapse is very crucial.
     
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  19. Griffin

    Griffin

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    I agree. But I think follow up should be many years. I was also thinking if there is a positive response and if that is attributed to Rituximab, then it is no longer fully blinded anyway.
     
    deleder2k likes this.
  20. twentyyearsandcounting

    twentyyearsandcounting

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    What do they mean by:

    Maintenance at 3, 6, 9 and 12 months

    Maintenance sounds different than treatment.
     

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