Phase III Rituximab Trial - News

Terrible news from Marky90 at PR:

http://forums.phoenixrising.me/index.php?threads/rituximab-phase-iii-negative-result.56244/

 

I should add that Fluge and Mella have sent letters to the participants.

 

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.

 

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.

 

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.

 

Oh crap... I'd even been wondering how to mail myself to Norway to get treatment...

 

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.

 

All I know is there are plans of further studies from the research team at Haukeland. Don't know any details though.

 

Unsurprising.

 

At least you've made me laugh a bit!

 

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?

 

Massively surprising to me!

 

@Sasha I think we need to check the primary outcomes. Marky90 was hypothesising about the actiometers

 

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...

 

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.

 

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".