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Crohn's Disease Forum » Treatment » Entyvio/Vedolizumab » Vedolizumab, was switched last week to new part of trial : (


09-04-2009, 05:33 PM   #1
shmooda
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Vedolizumab, was switched last week to new part of trial : (

As week 10 arrived of my PhaseIII trial, they switched things up. I either got the drug I was on, different strength of the drug or a placebo. Day 11 now and I know it was switched. Cramping and pain are back and I am having more BM's. So they lowered the strength or the placebo is in place. I talked to the Dr yesterday and in 2 months I can be switched to the actual drug as long as I am steel feeling bad. At least I was lucky enough to feel good for 10 weeks! I have another infusion of the new stuff on the 22nd and hopefully the month after they will switch me back.:depressed.
09-05-2009, 10:56 PM   #2
Lisa5326
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Sorry sorry....You've done awesome, hang in there dear!
09-06-2009, 11:17 AM   #3
shmooda
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Thanks guys! I will def hang in there for the full year. Shanel... thank you, I never thought about the fact that every med out there had a clinical study... that really made me feel better. I know eventually I will be on the real drug, so there is a light at the end of the tunnel.
09-06-2009, 11:36 AM   #4
saidinstouch
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Think of it this way, you are part of bringing a new drug to market that could benefit a lot of people. It will suck to suffer for 2 months, but if the differences are that drastic, then I'm sure others are having the same effect and this arm of the trial is to prove just that fact. Hopefully you can make it the next two months and then maybe it'll be smooth sailing from there. If the results are great enough and safety clean enough we might see this on the market for the rest of us in ~2 years, depending how far into the pIII trial it is, it could be less, though that is unlikely.
09-06-2009, 11:43 AM   #5
shmooda
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If the drug passes this final phase it will be 2-3 years before it is FDA approved. The doctor told me I can stay on the drug at no cost for up to 3 years, so I assume until it is marketed.
09-09-2009, 10:16 PM   #6
shmooda
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I go back on the 22nd for the lower dose. Hopefully Oct. or Nov, will be on the actual drug. I'm hanging in there! I can get the flu shot but because of the trial I cannot receive the H1N1 vaccine while on the study. No live vaccines allowed. Thanks to all of you I feel I can go on with the study. Thank you all for the support, I appreciate the response!!
09-10-2009, 04:58 PM   #7
shmooda
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My clinical nurse is checking it out, but the original swine flu shot in the 80's was a live vaccine. I'll let you know on the 22nd when I go back.
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Crohn's Disease Forum » Treatment » Entyvio/Vedolizumab » Vedolizumab, was switched last week to new part of trial : (
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