Sudden end of drugs trial

[lisa]

Hi all not been around for ages but just wanted to share this with you . If been on a tysabri drugs trial for nearly three years with the first two years not knowing if I was on drug or placebo then everyone got to go on drug which I was very happy about with there being no drugs for spms so here was me thinking win win was unsure if we were all going to have 2 or 3 years of tysabri an then last week the hospital rang to say we are really sorry we had an email today saying the drugs company has stopped the trial so you don't need to come in tomorrow now !!! I was blumin gobsmacked the trial nurses said they didn't see that coming but the drugs company's are a law unto themselves so now I'm back to not knowing what I'm going to do got to go and have achar with the neuro next week and see what he has in mind.

 

 

Thanks for reading my rants

 

Lisax

[jayjill]

Hi Lisa, that is REALLY disappointing - you should have received an explanation from Biogen at least. Have you read the 'latest news' section on the ms-uk site? That might help to understand what is going on. Jill x

[Nick]

Hi Lisa,

I'm still on the 'ASCEND" trial (extension) and have been on the real drug for around 6 months, last time in was week before last and I have not heard anything about the trial ending. I do know that the extension part only lasts a maximum of two years.

 

Post Note: Just read this! So you could be right!!

 

http://multiple-sclerosis-research.blogspot.com/2015/10/newsspeak-aftermath-of-negative-ascend.html

 

Nick

Edited 24 Oct 2015, 7:00 pm by Nick

[lisa]

Thanks for you replies and Nick when the hospital rang me I did ask if the trial had been stopped for everyone and was told it was all 16 countries an all the 889 or there about people had stopped so sorry you found out like this I would ring which ever hospital you were on your trial with an check and please let me no if it is the same

 

Thanks Lisa x

[Nick]

I will keep people posted. Of course it was only a trial and it was explained that the length of that trail was open ended. The other thing is with myself being JC positive, then if I have been on the drug for 2 and 1/2 years it was probably time I would have had to have come off anyway. Bit unexpected though.

 

Nick

[Scully]

Crumbs.. That's all a bit disappointing for you all. I guess the 'big pharma' can pull the plug whenever they want to on these trials, but it's a big blow for all concerned.

 

I guess, if you know you've been on Tysabri and it's helping, maybe your neurologist may want you to continue with it, albeit 'off trial '?

 

Scully

 

[Nick]

I have just this minute learnt from my trials unit that it is indeed ending. I will need to see the trials neurologist and have one last MRI and that is it

 

Getting away from the personal side, I feel it's a shame that this particular drug is proving inconclusive when dealing with SPMS. Clearly we are now starting to see new trails looking more towards the management of the secondary and the progressive, using similar but newer drugs, which is possibly the reason why this particular trial is being ended. It is also of course fair to say that the original trail had ended, it is the 'extension' part that has now been cut. The protocols for these drugs trails are pretty impressive and I feel certain that in one sense the whole thing has been 'successful' It is however hard to take as the one who knew they were getting the drug. News clip on the subject below:

 

.... The Phase 3 ASCEND study investigating natalizumab in the treatment of secondary progressive multiple sclerosis (SPMS) did not achieve its primary and secondary endpoints...

 

.... Given the challenges of treating this advanced stage of MS, these results underscore the importance of treatment early in the course of disease with effective disease-modifying therapies before a patient advances to SPMS....

 

.... ASCEND evaluated the efficacy and safety of natalizumab to slow the accumulation of disability progression unrelated to relapse in SPMS patients, an unmet medical need. The majority of study participants had EDSS scores of 6.0 to 6.5 (walking aid required) and were non-relapsing for two years prior to enrollment in the study. The study’s composite primary endpoint evaluated the percentage of patients whose disability had progressed on one or more of three disability measurements comprising the composite endpoint.....

 

..... Natalizumab demonstrated a statistically significant effect on upper limb function (one of the three components of the primary composite endpoint) unrelated to relapses. Consistent with the established effects of natalizumab in relapsing multiple sclerosis, analyses of exploratory endpoints suggest that some patients received a benefit from treatment, including reduction of relapses and new MRI lesions .....

 

..... SPMS is characterized by ongoing nerve damage or loss and patients experience disability progression with increasingly less frequent relapses. Despite extensive clinical research, treatment options for patients with SPMS are extremely limited and none have demonstrated efficacy in slowing the progression of disability unrelated to relapse.....

Edited 26 Oct 2015, 10:36 am by Nick

[lisa]

Hi sculls my neuro can't prescribe tysabri for sp ms as its only been passed for rr ms so still no drugs for us sp msrs ! But I was honing to have a proper look at diet has anyone tried the pale diet .? Looks interesting !

 

Lisax

[dantanfig]

ive been on a tysabri drugs trial for just over three years

it was a bit of a shock when i got the phone call last week

 

mark

[Nick]

Well yes, I felt the same............lucky for me Lisa pre-warned me so it was not quite as bad, and when the lady rang up she was surprised (and a little relieved) that she was not going to have to break the bad news.

 

The way to look at it is that for SPMS Tysabri has been found to be ineffectual..............so why would I want to carry on with a drug that IS ineffective AND carries the additional risk of the (slight but real) risk of PML............that's what I signed up for, an experiemntal trial, and that is what the results showed.

 

Nick