Teriflunomide

Aubagio is an oral treatment approved for MS.
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DM
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Post by DM »

Yes, for the 1st quite a few months, almost 2/3-3/4 year I think, I was visiting the hospital every 2 weeks for blood tests, scattered in there for urine test, and every 6 weeks, ultrasound and MRI. For quite awhile now, I must go every 5 weeks to the hospital and every 3 months for the ultrasound and MRI. And every so often, they throw in the timed walking tests, math quizzes and peg in the hole tests.

They have to monitor you very closely or else they cannot oversee the interim results of the drug.

Don't know how you are going to get around that one.

And yes, no SFX at all, even after all this time.
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Mikey
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Post by Mikey »

DM.... when will you know if you have been taking the placebo or not?

they want me to participate in this study since i am CIS and only had one attack...that has not fully gone away for the last 45 days.
I just cant stand the thought of blood draws every two weeks and all that testing... i just really hate needles.

Does anyone know if we can get the pills tested by an independent lab to see if its the drug or a placebo.
Id hate to go through all those tests and not to benifit from an actual drug.
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DM
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Post by DM »

First of all, before you come to any hasty decision regarding this drug, read the threads pertaining to:
Avonex, Capaxone, Betaserone and Rebif. Would that be a better alternative for you? Needles you inject yourself!!! daily or weekly? The cost is expensive. SideFX too?

Pop a small pill once a day. For the first 6 months, visit the clinic every 2 weeks, get one needle to suck out a few tubes of blood, pee every so often in a small bottle, and do some math, coordination and walking tests every 6 weeks at first. Then it goes to 4, then 6 weeks for the blood tests.

Small price to pay, especially if you look at the alternatives.

They monitor you very closely, and if there are any changes for the worse, you will be notified almost immediately, and looked after.

Sometimes the doctors can determine by your blood tests whether you are on the placebo or not, but easy for women patients and very difficult for men patients. Don't bother getting the pill analyzed by an independent lab...the cost, and whether they will do it or not is of another matter.

I don't enjoy needles, but this is the lesser of 2 evils. Just a 2 year study and then you get on the real pill after, regardless.

Ask me any other questions if you have.


Danny
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Mikey
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Post by Mikey »

I have read many other completed phase 2 and 3 trials that show the drug works. the 7mg pill reduced the active lesions by 65% and the 14mg pill reduced activity by 85%
I just dont want to be on a placebo for two years and have more lesions develope.....once the damage is done .....its not reversable.
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DM
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Post by DM »

If the MRIs are showing lesion growth, and you are on the placebo, they will most likely switch you to the real pill. That is why they monitor you so closely throughout the study.

MRIs every 4 months as well as ultrasounds so you won't have to worry. If there are any changes in your health, they will adjust as needed.
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MartynW
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Post by MartynW »

Mikey,

The thought process that swung me on to signing up was, you can opt out any time, you only get one chance to opt in.

Been on it 5 weeks now, no side effects, hardest part is remembering to take the pill.
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DM
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Post by DM »

You too!

Forgetting to take the pill. Have done it many a times occasionally.

When something doesn't hurt or bother you, you jusst plain forget to take those things. I take mine in the evening but if you don't sit down with them at dinnertime, you walk away and forget.

And I thought I was the only crazy one.............
Last edited by DM on Wed Jul 22, 2009 7:06 pm, edited 1 time in total.
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MartynW
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Post by MartynW »

I put all my wallet, cellphone and keys on the box, so I can't miss them in the mornings :p
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DM
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Post by DM »

And my wife screams at me because all she finds are these little white and silver tabs all over the place lol
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Mikey
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Post by Mikey »

GOING IN THIS MORNING TO START THE DRUG.
HOPEFULLY I GET THE REAL THING
They said they would not change the drug if they started me on the placebo and i get worse in the future.
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DM
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Post by DM »

Mikey, where do u live, as in city?
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Mikey
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Post by Mikey »

I'm in Gilbert Arizona.

i think i got the placebo... they said most people feel nausiated when they take the first pill on an empty stomach but i felt nothing...and 5 hours later still feel nothing.
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DM
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Post by DM »

I never felt sick either. Don't know what I am on but the lesion at the base of my brain has shrunk dramatically. Whether this was a natural occurrence or the drug, who knows but the nurse told me that during Phase II, one patient swore that he was on the placebo and when the results came in, 14mg.

So, I would not determine what you are on based on nausea. The Drs. have a difficult time determining what you are on as a male, much easier as a female. He doesn't know why either.
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MartynW
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Post by MartynW »

I felt nothing as well, so we're either all on the Placebo, or that "test" is useless, i suspect the latter as Phase II showed just as many of the Placebo takers reported side effects as the active drug. In fact more people on the Placebo reported Nausea and Diarrhoea that those on Active. :p

I know it sucks, but you'll just have to do what we all do, and accept the trial as is, and cross fingers.
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DM
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Post by DM »

Mikey wrote:GOING IN THIS MORNING TO START THE DRUG.
HOPEFULLY I GET THE REAL THING
They said they would not change the drug if they started me on the placebo and i get worse in the future.
Okay, just to clarify.

If your condition gets worse while on the teriflunomide, or placebo, the alternative is to start one of the USDA apprvoed drugs, such as interferfon, Avonex, capa...

The study with teriflunomide that I am on has been closed. Your study is probably for another list of symptoms regarding MS. For the one time hiy, like me, in the early stages, it is now over, and I am one of the last to complete the study
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