Extension blood draw rescheduled!

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby ssmme » Wed Mar 12, 2008 6:43 am

I'm not sure if this is the proper place to post this but...

I received all the info on the extension study and go in tomorrow (Mar 13) for my final IIb visit. In the last couple of months my MS symptoms have been much more prevalent than prior to that time while in the study. More tingling, muscle weakness, extreme fatigue. In reading the extension study info I interpreted it to say that we will receive dosing just like we did during the IIb study. If that's the case then we'll all go 6 months again just being followed up after getting vaccines during the first 6 months. I'm worried that if I'm getting the real thing then going 6 months with no vaccine isn't good for me. I know it's all speculation when you don't know if you were getting the real thing or placebo. Does anyone know if we'll be able to request additional dosing if 6 months off isn't good for a study participant?

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Postby Lyon » Wed Mar 12, 2008 8:04 am

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Postby Loobie » Wed Mar 12, 2008 8:33 am

I don't think they would give extra doses at all. The results of the study can only be used if every "guinea pig" is following the same protocol. You don't know how to measure if you don't know where you are measuring from and if everyone's getting different regimens, you lose all control of your control. While that may be what we would want to happen, while you are in a trial, you have to go by the protocol or it's null and void. Since it's not FDA approved yet, you would have to drop out, but then you couldn't get Tovaxin anyway since it's not approved. Now I didn't read that anywhere or anything, but your results would not be considered if your protocol was different, and then they would have no use for your data in the final analysis and would therefore quit spending the money to make your drugs.
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Postby MaggieMae » Wed Mar 12, 2008 8:38 am

Bob,

I didn't mention in my post that we personally know a woman who took the Imuran and over 30 years later, she is walking around with no assistive devices, etc. Her first attack was major and she started the Imuran almost immediately. She never had a severe attack again.

Maybe you are right. But..
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Postby Lyon » Wed Mar 12, 2008 11:42 am

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Postby MaggieMae » Thu Mar 13, 2008 5:12 am

Bob,

I'm going to say around 20 years. She started in the mid 70's. She told me she never had an attack but she would get really hot and sometimes she would even go outside in the winter (snow) to cool off. I haven't talked to her for awhile. Last time I did she was going fishing with her family.

I don't know the dosage either.
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Postby Lyon » Thu Mar 13, 2008 5:25 am

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Postby Jamie » Thu Mar 13, 2008 9:01 am

Wouldn't that be wonderful Bob?

Imagine being able to get almost nostalgic over the paucity of MS treatments.

<stares wistfully into the middle distance>
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Postby ssmme » Thu Mar 13, 2008 9:57 am

Lew and Marcia, the news seems more favorable than I would have guessed.


Lyon,

I'm so happy to hear this. It's a relief of sorts.

I just got back home from my final IIb visit/first extension visit. I'll know in approximately 2 weeks if I'm still producing MRTC's. Doesn't it seem sort of wrong to hope you've still got MRTC's so you can get vaccine made considering it's the MRTC's that seem to be causing the illness/deterioration/progression of disease etc. to begin with? OXYMORONIC

My final visit has my EDSS back at a 3. I am really hoping everything goes uneventfully on schedule with procurement and vaccine production. I feel that I'm in real need of a "booster" right now. The fatigue is the worst of all. I wish I could find a "puppy upper" that would give me some renewed energy without making me feel hyped up on a drug (legal of course too).

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Postby Lyon » Thu Mar 13, 2008 11:35 am

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Postby hmtucker » Thu Mar 13, 2008 12:57 pm

ssmme wrote:I just got back home from my final IIb visit/first extension visit.


Marcia,

We're exactly 1 week apart in the timing of our IIb/extension study with the Lexington Associates in Neurology as I go in next Thursday for my final IIb visit and MRTC blood draw. If all goes well, in our twisted logic sort of way, I will again be MRTC positive and I'm scheduled to go back in on April 3 for the big bag of blood donation.


Good Luck,
Mike
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Postby ssmme » Fri Mar 14, 2008 4:17 am

Mike,

I will be keeping my fingers crossed for you too.

Are you seeing Dr. Twyman? I was seeing Dr. Shojai but he left the practice to open his own office in Hamburg Pavilion area somewhere. I have been reassigned to Dr. Chumley. I've seen Dr. Twyman once but according to Laura his schedule is booked tight with patients. Chumley seems pretty nice and the staff at AIN has been very cordial to me. They are as much of my MS support team as the doctor is. I'm not going to leave to follow Shojai. What's your opinion about this?

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Postby hmtucker » Fri Mar 14, 2008 5:23 am

Marcia,

ssmme wrote:Are you seeing Dr. Twyman?

Yes, I've seen Twyman for all of my visits and he's been very good. I've not seen either of the other docs that you mention.
ssmme wrote:and the staff at AIN has been very cordial to me. They are as much of my MS support team as the doctor is.

I agree, the research and nursing staff have been very nice and supportive during the whole process. They have helped to make the year go by very well. I feel that they have always been very open to answer questions and if they don't know the answer they have always gotten back to me with an answer.
ssmme wrote:I'm not going to leave to follow Shojai.

Are you sure that would even be an option? I think it's quite a commitment to run these studies both in terms of support staff and agreements with the research company. So, Shojai's new practice may not even be an option. Since the research support staff at AIN is so good and such a big part of the whole process, I would feel very comfortable continuing on at AIN even with a new doc.

Take care,
Mike
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Postby ssmme » Fri Mar 14, 2008 12:31 pm

Mike,

Are you sure that would even be an option? I think it's quite a commitment to run these studies both in terms of support staff and agreements with the research company. So, Shojai's new practice may not even be an option.


I agree about the study. I would definitely stay with AIN since that's where the study is but I don't think I would jump ship following the study to continue with Shojai.

Everyone out here,

Why is it that if they can't currently make vaccine from the new blood draw that they can't continue to make vaccine from our last blood draw. I thought that theoretically they only needed one pint to make a lifetime of vaccine. If they continue to check our blood for our MRTC count it probably won't matter from which batch the vaccine gets made. The number of MRTC's may change but the makeup of the MRTC's doesn't. Am I missing something here?

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Postby Lyon » Fri Mar 14, 2008 12:52 pm

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