How to join and start a Rituximab trial

[snowathlete]

Im relatively young, i guess. 30 now.

Had this illness about 3 years.

The decade before that i worked really really hard for my career. Now its gone down the shoot. Even if i got well tomorrow and went back, its going to be a year before i am back in the swing of things, and at least that until an employer is going to want to put trust in me again. So best case scenario i have lost 5 years really. Minimum.
I guess i can recover from that and have a half descent life, but not if it takes another decade till im treated effectively.

Worst for me, is that my daughter was born this year, and i am afraid that i wont ever be able to do anything with her. Take her to a theme park, run with her in the park, etc etc. I can take losing my career, but not that.

And by the way, i feel damn lucky that i got this illness this decade and not the decade before, or earlier, as i know many of you did. I genuinely feel upset for those of you who have had this so much longer than me and already lost so much. I hope you get treated before me and at least get some time to do things that you deserve to do.

 

[Sallysblooms]

A huge amount of attention has been paid to supplements in the treatment of ME. The supp manufacturers have been making a fortune out of us. I must have tried hundreds over a period of 30 years, and have no clear evidence that any of them have done me any good at all.

Jenny

Many doctors are clueless about supplements so patients are trying to do it themselves. I have MD's that know amounts and the exact supplements to take so that is what is needed, more integrative MD's. Things like Proboost and many others will do so much if taken correctly.

 

[Jenny]

Hi Sallysblooms

I'd be interested to know how your docs know the exact supplements and exact amounts. Many of mine over the years have tested me for levels of all sorts of things and claimed to know the precise amounts of dozens of supplements that they said I needed, but I'm no better. My most recent protocol is 28 different supplements. I've been on them for 8 months and after 6 months on them went into my usual autumn bedridden relapse. I think after I've finished this lot I'll just take a multi-vitamin, vit c and Mg.

Are there any particular tests you've found useful?

Jenny

 

[redo]

Anything is better then this sickness. This is the first thing I have seen that absolutely makes sense to me. The only thing is how many years do we have to wait before its something they will freely give us? I honestly think I will be dead before something actually gets done. By the time clinical trials are done, approval, and our doctors are willing to do it, how many more years do we have to wait? I have been waiting 15 bloody years, I lost a prominent career after 20 years of hard work. I can never go back now its too late for me. How many young people will lose careers and marriages etc because the process will just take so long. Im feeling very bitter today sorry despite this good news lol

I don't have any more years to lose. I am not getting any younger, that's for sure. So I'd rather spend money I don't have on a long shot to get well, rather than remain in the status quo. I am guessing we'd be looking at at least two more years until large studies are finished, if not more. The one which was published recently was begun in February 2009, so two and a half year later it's publised. If a bigger trial where to take place somewhere on earth, it's likely that we'd be looking at months if not a year before it'll be on it's way, and than add years to get it done, and published. I don't have that much time.

 

[Jenny]

Me too redo. Had ME for 30 years, and now 61. I'm running out of things to try and running out of time. I'd been willing to participate in a trial.

Jenny

 

[redo]

... I'd be willing to pay for the drug myself, even though it costs over 5 grand per infusion, and I don't have that money.

 

[Jenny]

How about a trial of methotrexate redo?

http://forums.phoenixrising.me/showthread.php?14382-Methotrexate-(oral-drug-similar-to-Rituximab)

 

[redo]

Methotrexate was studied in the original Mella/Fluge study (the study of three patients), and they concluded they thought it didn't have an effect. But, it's only a study of three patients, so I would be supportive of a trial for Methotrexate in ME. If I had no other options, I'd even pay for getting it done with myself as well. So +1 for the suggestion Jenny, and I support it, but given the results which are avaiable now, I'd have Rituximab as a first priority, and other immune modulators as second priorities.

 

[Holmsey]

Main thread

I think I read in the main thread where this thread was linked that the Norwegian phase two study would take three years to complete. My undertanding is that following that there would be a phase 3 trial before any approval for Ritiximub in ME/CFS was given, and that assumes no problems. I'd also conclude that the likes of the US/UK would want their own three phases, or does it not work like that? In either case it seems a long time to wait.

I noted in the interview(Cort / Mella-Fluge?) that it was indicated lack of funding and the fact that this study isn't the main role of either those doctors or the Norwegian University hospital would delay results. I'm not against any of the suggestions thus far made but to me, the best way forward would seem to be to find ways to assist the process which is ongoing.

If we could find accord accross the best of sites / organistaions like this one then we could perhaps start a dedicated fund, where individuals or recognised groups contribute in order to speed up that research. In the interview the lack of one position was sited, memory is crap, but I think it was a microbioligist to assist with the bio data collected during the study and to establish what the measures meant. Seems a smaller but achieivable task if we all work together.

 

[redo]

There are several perspectives on this issue. One is, being a patient, wanting to try the new drug without waiting for years and years. In that perspective we've got to make stuff happen ourselves. Getting selected for a trial is just tiny chances for (tons of patients wanting to get in, only a few do). The scientists in Norway are doing a follow up study which they do have funding for (30 patients, plus 10 severely bad patients). The scientists behind the study wants others to do trials as well. The easiest trial to set up are case studies, where one just gets a small group of people together, the doctor issues symptom schemes, we'd get funding one way or the other (short story). Otherwise, we'd have to wait for more years and or should I say eternities to go by.

 

[ukxmrv]

If anyone can think of a UK doctor or researcher to ask I'd be happy to write to them.

It's at times like this that Dr Kerr is really missed.

 

[Andrew]

I was speaking with urologist about this. Although he is a urologist, he loves keeping up with research, and he likes to chat with me about CFS. I wish I could meet PCP who is this interested in CFS.

Anyway, a few things came up in our chat.

You can't just ask any old doctor who give you this treatment. It should probably be someone who is set up to deal with this. Like a an oncologist. But just any old oncologist would not good enough. They would have to really be into this, and willing to read up about CFS. This would take time and dedication. Hard to find. Also, cancer drugs cost a fortune. And could you really get in insurance company to pay for this. What tests could one take to prove to the insurance company they need this.

BTW, I read something by Byron Hyde that explained why insurance companies are so particular this way. He said may years ago, insurance companies would just pay for whatever doctors ordered. They assumed doctors were professionals who used appropriate professional discretion. But too many doctors would order all sorts of unnecessary treatments so they could make more money. So insurance started policing everything.

 

[redo]

It's good that you've been doing research Andrew! Yes, it's true it has to be an oncologist (with experience of Rituximab use) or an immunologist in the picture. But they don't have to have a central role. You could get a CFS doc to most of stuff, and the oncologst/immunologist to do the infusion. It also has to be done in a hospital, as they hook you up to monotoring machines while dispensing. It sounds dramatic, it's simply because in some very rare cases the patient gets a reaction which needs medical care right away. As long as the machine is there, there's not much to worry about. Many doctors know doctors in the hospital, so if you're getting a CFS doc onboard, they might be able to get a hospital doc to play a role...

Yes, it costs a lot. Some over five grand per infusion. If it's possible to get insurance to chip in, than that's great! If not, I would pay myself (despite not being wealthy at all).

 

[kurt]

I was speaking with urologist about this. Although he is a urologist, he loves keeping up with research, and he likes to chat with me about CFS. I wish I could meet PCP who is this interested in CFS.

Anyway, a few things came up in our chat.

You can't just ask any old doctor who give you this treatment. It should probably be someone who is set up to deal with this. Like a an oncologist. But just any old oncologist would not good enough. They would have to really be into this, and willing to read up about CFS. This would take time and dedication. Hard to find. Also, cancer drugs cost a fortune. And could you really get in insurance company to pay for this. What tests could one take to prove to the insurance company they need this.

BTW, I read something by Byron Hyde that explained why insurance companies are so particular this way. He said may years ago, insurance companies would just pay for whatever doctors ordered. They assumed doctors were professionals who used appropriate professional discretion. But too many doctors would order all sorts of unnecessary treatments so they could make more money. So insurance started policing everything.

Interesting input from your doc. There are so many cancer treatment centers out there, and many times they just delay the inevitable, prolong life for a few years, for their patients. Perhaps they would like to treat some patients who will eventually fully recover? Might be good PR for the cancer centers if they could repurpose some of their abilities to help a major underserved patient population... That is a VERY interesting idea, to work with oncologists, and perhaps also immunologists who are already comfortable with major immune system modulations. But they would have to find this interesting. Perhaps the fact that ME/CFS patients are known cancer risks for some types of cancer? Would that make us relevant patients to them?

 

[redo]

Here's a list of centers which took part in the great double blinded Rituximab study on MS published in nemj. Those participating in the study are immunologists who have:
*) Experience that the drug work against MS
*) Knowledge of how the drug works, and permission to use

If a patient presents himself/herself with brain fog, fatigue, memory problems and more - than that's pretty familiar to the doctors as well, because that's pretty much hallmarks of MS as well. Clicking here, and contacting a facility near you might be an idea.

 

[Snow Leopard]

If it's possible to get insurance to chip in, than that's great!

They won't until there have been more trials done. It's a catch-22.

If anyone wants to participate in a (self funded) case study type trial, then you need to standardise the outcomes - since the trial will not be blinded, then along with generic questionnaires before and after (eg the SF-36), you need objective measures of outcomes - ie you need to wear actometers periodically to demonstrate improvement in activity levels over 6-12 months.

 

[Jenny]

I asked Dr Murphy of the Royal Free 'Fatigue' Clinic if there was any possibility they would consider a Rituximab trial. She's interested in the findings, but said that it would be futile to try to get ethical approval for a trial before the debate concludes, and funding would not be considered until ethical approval is gained. But she agreed that a larger trial would be very useful.

So at least a positive response to the importance of the work, but perhaps expecting trials in the UK in the immediate future is a bit optimistic.

Jenny

 

[Kaoru]

I posted about plans for a new trial here:

http://forums.phoenixrising.me/show...CFS-mystery!!!&p=216399&viewfull=1#post216399

 

[redo]

Very well Kaoru. It shows cleary that yes, it can be done!

I think we've got more reason for optimism than that Jenny ;-). Mella/Fluge first had one patient, she improved drastically (by chance), they than applied for ethics approval to treat 3 patients, they got yes, they than applied for ethics approval to treat 15 patients, plus 15 with placebo, they got yes. And they have some other small studies going (about same size as last). If they can, we can! Larger studies are generally considered 100+ patient studies. I am primarily taking about case studies as a means of being allowed to use the drugs ourselves. That's the major point. Community benefits too, but the main focus is on getting the drug. It might be partially self funded if not other creative methods are sought out.

 

[sandralee]

I discussed Rituximab with my doctor yesterday during a phone consultation.

He indicated that hed had 2 patients in the past with RA who had Rituximab, but he wasnt aware of any improvements in their ME/CFS symptoms.

He then went on to say that this doesnt confirm no improvement, only that nothing was mentioned. He said some people dont mention improvements as they put it down to an upswing, and he didnt ask, as he wasnt looking for any change apart from their RA symptoms.

Unfortunately, hes lost contact with these patients, so it cant be followed up.

Apparently Rituximab is mainly used by Rheumatologists in Australia, and he said that there would be no way of having a trial with ME/CFS patients before more trials had been done and long term outcomes could be assessed.

How on earth do you get more trials when health systems wont approve more trials until more trials have already been done!

Sandra