Phase III Rituximab Trial - News

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.
 
From another thread:

Scarecrow said:
I know! I keep thinking back to IiME this year. The team were supposed to be breaking out the champagne at New Year. Of course, that was before the code was broken but what has happened? Anyway, that train of thought's for a different thread.
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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?
 
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.
 
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Sasha said:
What's your interpretation? Not sure what you mean about primary outcomes...
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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".
 
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