Rituximab study in norway. An application to The Research Council of Norway

[IreneF]

Around 2/3 respond rate from all studies conducted in Norway. I think that is what we can expect from the new study launching this fall.
@IreneF, that is why they're now giving one infusion, one more after 14 days, 3 months, 6 months, 9 months and one final after 15 months. I don't know how many you got. They think that this could make the effect last.

That was the schedule I was on.

 

[NK17]

I'm sure @Jonathan Edwards will chime in at some point.

From what I know about Rituxan and RA and a recent visit with my rheumatologist @ Ucla, every RA patients responds differently and not every RA patients is a responder to Rituxan. Also Rituxan is usually not the first line of treatment for RA.

@IreneF the protocol and timing of the infusions is certainly something that Fluge and Mella have been working very hard to figure out and make as right as possible for the most of their ME patients, even more so for the phase III.

That's why we need clinical studies like the one in the UK @ UCL, studies that replicate intelligently and in connection with the original norwegian. It might seem a waste of time and money, but it's the only way we can go to advance the science, the understanding and translate that into a treatment.

 

[IreneF]

Just curious @IreneF, how strong was your response? Did you feel normal again, or just better?

I don't think it affected my dysautonomia symptoms. Plus I had been sedentary for so long, and I gained a lot of weight, on top of foot problems that cause leg and back pain and fatigue. . . so it's hard to quantify. But I felt like my symptoms would have been manageable if the response could have been sustained.

 

[IreneF]

I'm sure @Jonathan Edwards will chime in at some point.

From what I know about Rituxan and RA and a recent visit with my rheumatologist @ Ucla, every RA patients responds differently and not every RA patients is a responder to Rituxan. Also Rituxan is usually not the first line of treatment for RA.

@IreneF the protocol and timing of the infusions is certainly something that Fluge and Mella have been working very hard to figure out and make as right as possible for the most of their ME patients, even more so for the phase III.

That's why we need clinical studies like the one in the UK @ UCL, studies that replicate intelligently and in connection with the original norwegian. It might seem a waste of time and money, but it's the only way we can go to advance the science, the understanding and translate that into a treatment.

Absolutely not a waste of time and money! We need both basic science research to elucidate the cause(s) of this disease, and experiments with drugs that are already on the market.

 

[deleder2k]

@IreneF were you treated in Norway or in S.F?

 

[aimossy]

@DanielBR That was exactly the type of explanation I was needing. Thanks

 

[IreneF]

@IreneF were you treated in Norway or in S.F?

I was treated at Open Medicine (Dr. Kogelnik) in Mountain View, CA. I got a lot of flak for it from certain quarters, so I didn't talk about it too much. Now that formal research is going forward I'm more open.

Whether or not rituximab pans out as a feasible treatment for what we have, we need to find out what's behind the responses that patients have had (or not had). This work could be more important as basic research than as a potential cure. Maybe it will become one of many treatments that physicians can use. We need to find out.

 

[deleder2k]

Absolutely. Just got word from one of the Rituximab hospitals that I probably will be invited for a chat to see if "the study is something for me". If I do get the offer - do I have anything to loose?

M.E for almost 4 years. Since January I haven't been able to live by myself. Rarely go out. Fatigue, cramps, dizziness, OI, and pain is ruining my life. Tried a lot of different vitamins, including B12 sublingual, folate acid, LDN, sarotex (to ease pain). What do I have to loose? I know B-cell depletion could lead to Hypogammaglobulinemia. I also heard that acne is common. I have had some trouble with my skin after I got sick, but nothing serious. Two rounds of tetracyclines has fixed it.
I am sure they will tell me more if I do get the chance to participate, but I'd like to do some research on my own. I greatly appreciate answers from everyone, but especially from those who are M.Ds or those who have been treated with Rituximab.

 

[NK17]

@deleder2k if you get selected/qualify for the study I would say to absolutely go for it.

You'll be part of the phase III placebo controlled study done by one of the participating centers in Norway. The protocol is Fluge's and Mella's, the risks are well known, take this once in a lifetime opportunity to possibly turn around your health and with it your young life.

If you're risk avert or think that there might be other avenues of treatment available to you (in your country, from your doctor) which you haven't tried yet, then it's another story.

 

[deleder2k]

The only thing that I want to try that I haven't tried is gamma globulin. It is too late to try that now because of the study.
I asked if the placebo group would get Rituximab after the study is completed. The patients that participated in the first and second phase got that offer. I was told that it would be immoral to not do so (given that the results stayed the same), but they couldn't promise anything simply because they had no guarantee that they would receive funding to do so. The fact that they think it would be immoral not to do so, and that they would try their best to treat the placebo group after that study is very positive.

I have calculated my chance of getting a significant effect to only 33.5% (50% chance of Rituximab times 67% chance of effect), but that is way better than my odds without Rituximab. And if I get placebo I will hopefully be the 1st in line for Rituximab after the study is completed.

 

[NK17]

For me it would be a done deal. If you live close to the study center/hospital and you have somebody to assist you, you should seize the opportunity.

You seem to understand odds and chances of a possible remission and the possible side effects really well.

I cross my fingers that you'll get selected and hopefully be in the rituximab group .

 

[deleder2k]

It is 1.5 hours drive from my parents where I live now. I think I will be able to drive by myself. If I get in I have to go there a few times in the beginning and then every 3rd month. Everything consumes energy, but I guess this is worth whatever I got

Yeh, me too!

 

[LaPerla]

deleder2k: Can I ask, which hospital? Are they still recruiting for the mulitcenter-study?

 

[deleder2k]

Notodden Hospital. No, they are not. They haven't sent out anything yet. I just heard that I likely to be invited for a chat among with 50 others. The hospital will include 32 patients.

 

[LaPerla]

My finger's crossed for you

 

[Sasha]

Good luck, @deleder2k!

 

[Ninan]

Absolutely. Just got word from one of the Rituximab hospitals that I probably will be invited for a chat to see if "the study is something for me". If I do get the offer - do I have anything to loose?

M.E for almost 4 years. Since January I haven't been able to live by myself. Rarely go out. Fatigue, cramps, dizziness, OI, and pain is ruining my life. Tried a lot of different vitamins, including B12 sublingual, folate acid, LDN, sarotex (to ease pain). What do I have to loose? I know B-cell depletion could lead to Hypogammaglobulinemia. I also heard that acne is common. I have had some trouble with my skin after I got sick, but nothing serious. Two rounds of tetracyclines has fixed it.
I am sure they will tell me more if I do get the chance to participate, but I'd like to do some research on my own. I greatly appreciate answers from everyone, but especially from those who are M.Ds or those who have been treated with Rituximab.

A lot of people tell me I have nothing to lose. Sadly, I'd say I have a lot, even though without my meds I'm hardly able to communicate at all. It's not like there seems to be any limit to how bad this disease can get. But the reports look good and the risks seem to be pretty small. I would definetly go ahead. Hope you get to try!

 

[DanME]

Absolutely go for it!!! I would sell all my belongings to get this chance!

You would be treated by the world leading team in ME treatment. Even if you end up in the placebo group (I hope not), you will have the opportunity to interact with very experienced doctors and researchers. You will have a foot in the door for future treatment and tests. It is very likely, that they continue to treat you after the study.

I wish you all the best and sincerely hope, they ll pick you!

 

[deleder2k]

Yes, I was planning to say yes. Not sure if I know everything there's to know about the side effects though.

@DanielBR, Yes I certainly would. If treatment for ME/CFS with Rituximab will be available for the Norwegian public after the 3rd phase is done, I would hopefully be 1st in line.

 

[Ninan]

Yes, I was planning to say yes. Not sure if I know everything there's to know about the side effects though.

@DanielBR, Yes I certainly would. If treatment for ME/CFS with Rituximab will be available for the Norwegian public after the 3rd phase is done, I would hopefully be 1st in line.

Google it. There is info from RA patients out there and even though it's not certain it seems we can expect about the same adverse effects. PML is the worst (but very rare), worsened ME would be in second place (but I think you go back to where you were before when you stop taking it?) and then some allergies, pain, worsened psoriasis etc.