If the Norway Rituximab trials are a success - Will it be available worldwide?

[Murph]

I'm overall an optimist, but I also like to follow good scientific practice in making predictions. So we should find a good background probability for establishing whether the Rituximab Phase III trial will report a success.

My reading suggests that in some fields, around 40 to 60 per cent of Phase III trials fail. (1, 2, 3)

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Source: Clinical Development Success Rates 2006-2015

Rituximab is a Phase III trial so if we want to argue it is a higher chance of success than its peers, we need good reasons.

We can perhaps adjust our background probability for research coming from a stable European country, for researchers with no financial stake, and also for a disease with such strong Phase II trials. (Edit: some other good reasons to be more confident have been suggested below.) But there is no way the Ritux Phase III trial result unveiling is just a formality.

There remains a serious chance (perhaps 25 per cent?) that it comes back unable to reject the null hypothesis. I think it's important to keep this in mind so the patient community doesn't fall into despair if it happens - we have many irons in the fire at the moment and for once, not everything is riding on one research team or one study.

I wrote this in a moment of objectivity but in reality, in my heart ,I had basically everything riding on this study. :'( I'm gutted to hear it found no difference between groups.

 

[MEMum]

It is disappointing @Murph, but I do believe it will help further understanding of the physiology and biochemistry of the disease. There may well be a subset of responders. F & M are definitely not giving up on ME research and other researchers worldwide are making progress too.

 

[Kenny Banya]

It would be a massive surprise (as to be improbable) if the statistically significant response was in the placebo group

Well, I eat my hat.
I have never heard of such a drug response rate in Phase II, to be statistically insignificant in Phase III

I can only hazard that the it was something to do with diagnostic criteria changes or a sub-group. It just doesn’t make sense.

 

[Seven7]

I never got an answer on the IVs in Cfs is not placebo since we do very well on IVs due to dysautonomia, so how did they adjust for that?

 

[pibee]

I never got an answer on the IVs in Cfs is not placebo since we do very well on IVs due to dysautonomia, so how did they adjust for that?

i was considering this when i got iv saline bc dehydatation and then iv ceftiaxone..One day later huge improvent
this would make sense if daily or weekly iv, but they got it only few times in a year right?

 

[Seven7]

i was considering this when i got iv saline bc dehydatation and then iv ceftiaxone..One day later huge improvent
this would make sense if daily or weekly iv, but they got it only few times in a year right?

I was ending up on the ER about once a month for a few months, and the IV benefited me for around 3 weeks or so. I think it would balance my electrolytes or something. I got my issue resolved ( I used to have massive nausea that would not stop until I went to ER and got a shot and got dyhadrated from vomiting). Is all ok now ( that was a horrible symptom that I do not witch to come back).
But I guess the infusion might be some months apart. Still they have to see some increase on feelling good that might skew the results.

 

[Gingergrrl]

I don't believe the fluid of the IV plays any role in my case b/c my last two doses of Rituximab were three months apart and any fluid would be long gone. In addition, I do not do well with IV fluids and got pulmonary edema from IV saline in 2014. I require an unbelievably slow infusion speed and NO extra saline or Dextrose in order to tolerate the infusion. So I am the one person who does better with less fluid. But this might not apply to anyone else.

 

[Sallyagerharris]

Sorry trying to understand what is going on but are there reports that norweigan final clinical trials with rituxamib have not been successful??? Thanks

 

[Kenny Banya]

Sorry trying to understand what is going on but are there reports that norweigan final clinical trials with rituxamib have not been successful??? Thanks

Yes, unfortunately.