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

[deleder2k]

MEandYou: 3 million NOK
The Norwegian ME association 1.5 million NOK
The Kavli Foundation has also contributed

 

[Sasha]

MEandYou: 3 million NOK
The Norwegian ME association 1.5 million NOK
The Kavli Foundation has also contributed

That's very helpful - thanks!

 

[BurnA]

I don't think it is likely that with encouraging results the study would actually be closed. All that may happen is that unblinding may be allowed at 1 year and an early analysis made. That would not normally reduce the amount of follow up information on relapse and re-treatment being gathered.

One would assume the chances of placebo effect in year 2 would almost be negligible given the treatment will be stopped by then. Would this reduce any concerns over unblinding ? Even if they did unblind, due to lets say 50% response, would they have enough data at that point to write up their study for publishing / approval or would they need full data including response durations ?

 

[Jonathan Edwards]

One would assume the chances of placebo effect in year 2 would almost be negligible given the treatment will be stopped by then. Would this reduce any concerns over unblinding ? Even if they did unblind, due to lets say 50% response, would they have enough data at that point to write up their study for publishing / approval or would they need full data including response durations ?

I really don't know the answer to that!

 

[deleder2k]

Another update from Haukeland:

Status for RituxME: All 152 participants are included in the study and has started treatment. The centers does no longer accept applications for participation in the study. Each participant are being followed up for two years, without knowing whether they receive active medicine or placebo. This means that from the day the last participant received its first infusion, another two years must pass before the study is unblinded. The study will be finished in September 2017, and we expect to publish the results in 2018.

Source: http://www.helse-bergen.no/no/OmOss/Avdelinger/kreft/forsking-fagutvikling/Sider/RituxME.aspx

 

[BurnA]

Another update from Haukeland:



Source: http://www.helse-bergen.no/no/OmOss/Avdelinger/kreft/forsking-fagutvikling/Sider/RituxME.aspx

Roll on 2018
It's awful how you end up wishing time to go by instead of enjoying the moment.

 

[Sallyagerharris]

Thank you and another big thank you for the update. This is a beacon of light that is burning. X

 

[MEMum]

This is exactly what Olav Mella said to me as I sat next to him at a tea break at the IiME conference in May this year. Yes it really is that sort of conference: patients and carers have a chance to talk to speakers and other professionals.
He was clear that there would be no unblinding until the end of the trial. I did ask what would happen if they noticed that many participants were getting sig better, but his answer was the same.
I said that I realised 2 or 3 years was not long in terms of research, but that for youngsters (or really anyone else whose life is derailed by this disease) it's an eternity.

 

[BurnA]

This is exactly what Olav Mella said to me as I sat next to him at a tea break at the IiME conference in May this year. Yes it really is that sort of conference: patients and carers have a chance to talk to speakers and other professionals.
He was clear that there would be no unblinding until the end of the trial. I did ask what would happen if they noticed that many participants were getting sig better, but his answer was the same.
I said that I realised 2 or 3 years was not long in terms of research, but that for youngsters (or really anyone else whose life is derailed by this disease) it's an eternity.

If you happen to have a cup of tea with him again would you mind asking him how the cyclo trial is going

 

[MEMum]

If you happen to have a cup of tea with him again would you mind asking him how the cyclo trial is going

Hopefully he'll be at IiME 2016. I think it's early June and I will be going. @Deleder seems to get more frequent updates. If I bump into him before that I'll ask him.

 

[SOC]

I said that I realised 2 or 3 years was not long in terms of research, but that for youngsters (or really anyone else whose life is derailed by this disease) it's an eternity.

IMO, this is why we need to demand access to treatments that improve QOL even if they aren't established treatments for ME specifically. Our lives shouldn't have to remain in miserable limbo for the next 10-20 years while research catches up with the reality of our lives.

Research takes time. We can't change that. That doesn't mean we should live without any kind of treatment in the meantime. At the very least we deserve a better QOL.