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

ukxmrv

Senior Member
Messages
4,413
Location
London
"• Not any of the study centres are done including patients. Candidates are still being convened."
 

deleder2k

Senior Member
Messages
1,129
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?
 

xrunner

Senior Member
Messages
843
Location
Surrey
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.
 

NK17

Senior Member
Messages
592
Not sure if it is interesting or not, but I thought someone might find it OK to read.
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 ;).
 

deleder2k

Senior Member
Messages
1,129
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.
 
Messages
55
Location
London, UK
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

Senior Member
Messages
1,129
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.
 
Messages
55
Location
London, UK
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.