1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.

Phase III Rituximab Trial - News

Discussion in 'BioMedical ME/CFS News' started by Scarecrow, Nov 21, 2017.

  1. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
  2. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
    I should add that Fluge and Mella have sent letters to the participants.
     
    Barry, Yessica, Simone and 13 others like this.
  3. Cheshire

    Cheshire Senior Member (Voting Rights)

    Messages:
    276
    Likes Received:
    2,631
    How disappointing...

    Thanks for sharing @Scarecrow
     
    Barry, Jan, Yessica and 11 others like this.
  4. Skycloud

    Skycloud Senior Member (Voting Rights)

    Messages:
    202
    Likes Received:
    1,377
    Location:
    UK
    I'm feeling pretty deflated now, especially when I think back to the look of shock on my then GP's face when I told him about the phase 2 trial.

    Thanks @Scarecrow Good to know.
     
    Jan, Woolie, Yessica and 12 others like this.
  5. Trails

    Trails Established Member

    Messages:
    19
    Likes Received:
    164
    Location:
    rural New Hampshire
  6. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
    From what I gather, reading between the lines of Marky90's post, there does seem to be a responder subgroup even though the trial as a whole has been negative. I guess we'll just have to wait for the publication.
     
    Maggie, TrixieStix, Jo Best and 16 others like this.
  7. Cheshire

    Cheshire Senior Member (Voting Rights)

    Messages:
    276
    Likes Received:
    2,631
    Overall, I'm grateful to Fluge and Mella's honesty. They've never tried to spin their results. I hope they'll keep researching ME.
     
  8. ivorin

    ivorin Established Member

    Messages:
    18
    Likes Received:
    144
    Location:
    Zagreb, Croatia
    As long as they understand who it was helping, it may prove useful none the less - just hope it doesn't scare off other researchers.
     
    Maggie, Barry, Jan and 19 others like this.
  9. Trish

    Trish Senior Member (Voting Rights)

    Messages:
    840
    Likes Received:
    6,675
    Location:
    UK
    So disappointing. But if they can find a subgroup it helps, all will not be lost.
     
    Maggie, Barry, Jan and 20 others like this.
  10. Sasha

    Sasha Senior Member (Voting Rights)

    Messages:
    757
    Likes Received:
    4,710
    Location:
    UK
    Oh crap... I'd even been wondering how to mail myself to Norway to get treatment...
     
    Sue, Barry, Jan and 22 others like this.
  11. Anne O

    Anne O New Member

    Messages:
    2
    Likes Received:
    38
    I've been expecting this, just judging from anecdotal evidence from people outside of studies who have tried ritux.

    What I was hoping for was that the word from Fluge & Mella would be something along the lines of "only a smaller subset responded, but we're on our way to figuring out how to identify that subset". It worries me that what we're hearing now is not quite that, rather - judging from forums etc - an outright "it's negative".

    Also hearing rumours about the (much smaller and more preliminary) cyclophosphamide trial coming up with at least some positive results (a subset?) but that the side-effects have been tough on the patients.

    When, when, when, will we get our break? (I know, I know, a number of years after the federal agencies finally step up and fund ME research on par with other diseases - and that's a long way from happening...) But we'll have to try to keep fighting.
     
    Maggie, Manganus, TrixieStix and 32 others like this.
  12. Kalliope

    Kalliope Established Member (Voting Rights)

    Messages:
    98
    Likes Received:
    1,192
    Location:
    Norway
    All I know is there are plans of further studies from the research team at Haukeland. Don't know any details though.
     
    Ellie_Finesse, Barry, Jan and 28 others like this.
  13. Sid

    Sid Established Member

    Messages:
    20
    Likes Received:
    127
    Unsurprising.
     
    MErmaid, Aroa, BurnA and 3 others like this.
  14. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
    :grumpy:

    At least you've made me laugh a bit!
     
  15. Sasha

    Sasha Senior Member (Voting Rights)

    Messages:
    757
    Likes Received:
    4,710
    Location:
    UK
    From another thread:

    I don't generally expect PWME to have much spontaneous improvement, especially those of us who've been ill for a long time. So I wonder if the basic standard of care was higher for trial participants?
     
  16. Sasha

    Sasha Senior Member (Voting Rights)

    Messages:
    757
    Likes Received:
    4,710
    Location:
    UK
    Massively surprising to me! :arghh:
     
    Barry, Jan, Simone and 9 others like this.
  17. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
    @Sasha I think we need to check the primary outcomes. Marky90 was hypothesising about the actiometers
     
  18. Sasha

    Sasha Senior Member (Voting Rights)

    Messages:
    757
    Likes Received:
    4,710
    Location:
    UK
    I wasn't sure what he meant by that. But I do wonder whether actimeters helped patients to pace, or made them more aware of overdoing it.

    What's your interpretation? Not sure what you mean about primary outcomes...
     
  19. Kalliope

    Kalliope Established Member (Voting Rights)

    Messages:
    98
    Likes Received:
    1,192
    Location:
    Norway
    Blogpost from doctor and Rituximab-respondent Maria Gjerpe concerning these news

    Rituximabstudien - ikke mulig å påvise effekt


    google translation Rituximab study - unable to detect effect

    Edit to add:
    The blogpost has a picture with a slide from Mella's lecture from today.

    It is in Norwegian, but I have hastily translated it to:

    - RituxME: double blinded, placebo controlled intervention trial, with B-cell depletion in the active arm

    - Well performed trial with high quality data. Consistent results at the five centres. The main result is negative, in other words that we in a double blind setting can't prove that B-cell depletion (as it was done in the trial) affects the course of disease in a significant degree.

    - CycloME: open phase II trial with cyclophosphamide given 6 times with 4 weeks intervall (observation/registration 18 months). Good data, are considering how to move forward.
     
    Last edited: Nov 21, 2017
  20. Scarecrow

    Scarecrow Senior Member (Voting Rights)

    Messages:
    329
    Likes Received:
    1,497
    Location:
    Scotland
    My interpretation? I've no idea.

    The trial specified primary (and secondary) outcome measures in the protocol. The primary outcome (I think I should have used the singular the first time) would be the one Fluge and Mella considered the most important.

    The outcomes are specified in advance to avoid cherry picking the data* (PACE anyone?). I'm trying to find the protocol. I know someone put it up on PR but I can't see it yet.

    edited to add: *assuming you don't change them later because you think they're just.....well, "better".
     
    Last edited: Nov 21, 2017
    FreeSarah, Barry, Jan and 9 others like this.

Share This Page