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Crohn's Disease Forum » Treatment » Entyvio/Vedolizumab » Vedolizumab AKA MLN002


 
07-13-2009, 04:37 PM   #1
shmooda
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Vedolizumab AKA MLN002

I'm tired of sitting back and watching the world go by with no hope for a cure for Crohn's Disease. I have had the disease for 41 years and no meds have worked for me. Today was my first infusion with MLN0002. I am actually quite excited by this, although I must admit I was scared to death last night! The infusion took 1/2 hour and there was a 2 hour observation period after. The head nurse of this study never left my side! I am looking forward to 2 weeks from now when I get my second infusion!
07-13-2009, 07:22 PM   #2
My Butt Hurts
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Hey Shmooda - welcome to the forum. I hope this drug works for you! Keep us posted, you may be the only one on here with any experience with this.
Looks like we might be close to each other in location.
07-13-2009, 09:57 PM   #3
BWS1982
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He/she's in Rochester, not Buffalo.

Welcome, and good luck in the trailblazing of a potential new med for Crohns.
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07-13-2009, 10:05 PM   #4
My Butt Hurts
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BWS1982 said:
He/she's in Rochester, not Buffalo.

Welcome, and good luck in the trailblazing of a potential new med for Crohns.
BENSON!! You have no idea where I live!! Stop messing! Oh wait - you do know now. Still - stop messing!

Excuse Benson and I, we get silly late at night.
Welcome again Shmooda.
07-14-2009, 01:08 AM   #5
saidinstouch
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Good luck Shmooda and hopefully you're getting the drug and not placebo! What phase trial is this do you know? I could look it up, but my brain is pooped after a long day of research. Let us know how you feel along the way for sure!
07-14-2009, 12:15 PM   #6
Procyon
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^Pretty sure it's Phase III. Anyway, good luck shmooda. Keep us updated on things.
07-14-2009, 06:10 PM   #7
shmooda
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I am in PhaseIII of the trial. I actually think I am on the drug rather than the placebo. When the IV started I got a weird taste in my mouth. It went away after a couple minutes. So far no side effects. The nurse from the clinical trial called today to make sure all is well. I am the only person at the University of Rochester that qualified for the trial. Too many people that were interested have been on remicaid recently and you need to be off at least 6 months, they prefer it to be a year.
By the way I am a female!
07-14-2009, 09:19 PM   #8
saidinstouch
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You can get a weird taste in your mouth with any IV and they tend to add stuff to both drug and placebo to try and normalize or weird up the flavor of both sufficiently so you can't tell. I am still hoping you are on the drug and all, just wanted to let you know. I've experienced that weird taste with remicade, but not yet with Tysabri so it can be hit or miss depending on the drug, the facility, and probably even the saline used, as well as your body at the time.

Good luck and keep us updated!
07-16-2009, 11:46 AM   #9
shmooda
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saidinstouch......how long have you been on the Tysabri? Have you had any side effects from it?
07-16-2009, 03:02 PM   #10
saidinstouch
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I just got my 3rd infusion. No side effects to date that I can say would necessarily scare me of PML. Overall according to a CT scan I just had done during a minor flare, I am actually healing while on the Tysabri, but I honestly can't take the concern of PML much longer and will likely stop even if I am getting better. I already forget what I plan to say on occasion and other minor memory problems that aren't so bad, but everytime I forget what I am going to say I sit there thinking "is this it this time?" My assumption is that the symptoms would be fairly noticeable compared to my usual absentmindedness, but nonetheless, I don't think I can deal with it much more .
07-16-2009, 05:59 PM   #11
shmooda
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I'm so sorry. It must be a hard decision for you, not knowing if it's the treatment or your mind playing tricks on you due to the stress of knowing that there is a possibility of PML. My mind does that to me when I have alot going on. Do you have anyone in your area doing the MLN0002 study?
07-17-2009, 01:46 PM   #12
saidinstouch
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I just talked to the NP for my GI doctor today and she said they are looking to get enrolled in the Vedolizumab study. So while it is fairly similar to Tysabri, it has a much more specific molecular target meaning the off target effects should be greatly reduced. Though if the alpha4beta7 integrin ends up being the integrin responsible for causing PML somehow, then the profile wouldn't be any better safety wise (and only time will give us that answer).

I am hoping for a chance at this trial though since my doctor does think the Tysabri is working for me and getting my intestines healthier, so this would be a great step to goto since it would be having a very similar action with what I would hope are fewer risks.
07-18-2009, 02:33 PM   #13
shmooda
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I hope they can get you into the study. You are so lucky that your body has responded to the drug. Has any other drug ever worked on you before? I am looking forward to my next infusion on the 28th! I never thought I would be excited about having mystery fluids flowing through my body...lol.
07-18-2009, 03:22 PM   #14
saidinstouch
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Both remicade and humira did wonders for me...at keeping away abscesses and fistulas. However, neither of them were able to really control the inflammation in my terminal illeum and ascending colon, even at double the dose (or more for remicade). I kept ending up flaring and on prednisone again. Since the prochymal study closed right before I could enter and an Abbot IL-12 (protein target) study filled up right before I could enter it as well, I was sort of left with only one option left since even things like LDN didn't really do much for me.
07-19-2009, 07:45 PM   #15
shmooda
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Everytime I tried the remicade I would get a flare. The prednisone only worked for me when I was at 60mg or more. My doctor finally gave up on trying new meds on me. My daughter actually reads about all the clinical studies in Rochester and called me in the middle of the night. I am the only person in Rochester on this trial, I wish there were more. I wish there was someone to talk to about it!
07-28-2009, 02:21 PM   #16
shmooda
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I just came back from having my 2nd infusion. So far so good for a blind study anyway. My 3 day stint of nausea went away last night. I have to go through a neurological exam,bloodwork etc. in 2 weeks. Two weeks after that I get the 3rd infusion.
07-29-2009, 09:53 PM   #17
shmooda
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It's day 2 of my second infusion. I actually feel very good today! Had 2 bm's rather than my usual 10!!! I hope I'm not getting my hopes up but my spirits are def up. The nausea I had over the weekend is gone. I had a great day playing with my grand children!
07-30-2009, 07:00 AM   #18
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shmooda said:
Had 2 bm's rather than my usual 10!!!
Well THAT is a reason to celebrate!! Glad your nausea is gone. It could have been something completely unrelated - you might never know.
08-04-2009, 05:03 PM   #19
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Still down to 2-4 bm's a day! Next week I have an intense neurological workup and check-up. I am now starting monthly infusion. I actually mentally feel better having it every 2 weeks! I wonder why the switch? I do actually feel so much better, less cramping and pain.
08-05-2009, 10:26 AM   #20
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That's great news, Shmooda! I hope the checkup goes well and you keep feeling better and better.
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Diagnoses: Crohn's 8/07; steroid-induced diabetes 11/07; Remicade-induced Lupus 02/09, shingles 7/10, and hypothyroidism.
Medications: Entyvio, Methotrexate, prednisone, Protonix, Synthroid, fish oil, calcium, multivitamin, glimepiride. Failed Pentasa, Entocort, Humira, Imuran, 6-MP, Remicade, Tysabri, and LDN.
08-05-2009, 05:03 PM   #21
shmooda
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Thanks Kromom. I didn't know one of the side effects of Remicade was Lupus! I'm sorry! You should consider this study..... it's for people that the usual drugs don't work. You can stay on prednisone, then after week 6 they wean you off. This is the best I have felt in 40 years! I hope you are feeling well!
08-15-2009, 10:41 PM   #22
shmooda
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Week 10 on my clinical study! At this point I know I'm not on the placebo! YAY! I have an average of 3 bm's a day. Before the study it was at least 10 a day. I get nauseated on day 12 and 13 after the infusion. They don't think it is connected, but it happened twice. I have had breakthrough pain only once, but I am still on oxycodone. I just all in all feel better. I am now to the point that I am on monthly infusions ( I don't know how I feel about that). I go back on the 24th for my next one. They said that if I complete the year with positive results, I can stay with them on the infusions for an additional 3 years. Pretty cool!
08-16-2009, 11:00 AM   #23
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good!
08-19-2009, 02:39 PM   #24
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I should be starting this trial soon too and it certainly sounds promising, i'm just waiting for my hospital to get approval.

I've just introduced myself in the 'your story' section if anyone wants the full story but most recently i've just been on another clinical trial for a drug made by Pfizer, no name yet but it's 'called' CP-690,550. It's supposed to work in a different way to Anti-TNF and it targets a different molecule, known as JAK3. Oh and it's tablets rather than infusion or injection. It's still in quite early stages, I think this trial might have been stage II and it only lasted 4 weeks - had my last dose today.

The good news is I think it works, noticed a slight improvement in the 3rd week and more so in the 4th (BMs down to 4 per day compared to 7/8 before the trial). Of course this could be down to the fact that i've been on 20mg of Pred as well for about 6 weeks as I wasn't allowed to taper while on the trial. I'm to stay on 20mg for another 4 weeks as well and then go back for review so i guess it's these next few weeks when i'll find out if the improvement was down to the trial drug or not but it's another treatment that sounds promising.

Hope the Vedolizumab continues to work for you!
08-22-2009, 04:07 PM   #25
shmooda
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I hope your hospital OK's the study soon! It is the best med I have ever been on! As far as the prednisone... they allow you to taper off of it if you're doing well! That's great that the other trial had you on pills because you have to wait 6 months to start Vedolizumab if it was an infusion.
Good luck to you and I hope you continue to feel well!
08-24-2009, 12:52 PM   #26
shmooda
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OK....week 10 and the party begins. Had my complete exam, ekg,bloodwork etc. Now starts a new part of the trial. I either stay on same dose, get varied dose amounts or a placebo. Just received the mystery infusion today. Nothing like screwing with a good thing. Hopefully it's not the placebo because I have responded well to the last phase. Only time will tell!!
08-24-2009, 01:13 PM   #27
Ezio
 
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if you received vedolizumab in the first part you shouldn't recevoir placebo in the next part..
08-25-2009, 05:47 PM   #28
shmooda
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The clinic said it is possible to go on the placebo even if I was initially given the medication. It really doesn't seem fair. At this point I don't know which of the 3 options I have zipping around in my blood stream!
08-31-2009, 05:07 PM   #29
shmooda
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1 week since my mystery infusion. Still not sure if I'm on the same dose. My BM's are still only about 3 a day, so I don't think I'm on the placebo. Just have to wait and see what the next 3 weeks bring.
10-19-2009, 06:38 PM   #30
hazel
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[QUOTE=shmooda]1 week since my mystery infusion. Still not sure if I'm on the same dose. My BM's are still only about 3 a day, so I don't think I'm on the placebo. Just have to wait and see what the next 3 weeks bring.[/QUOTE Hi I am from Kansas and i started the trial study in April I just completed week 30 I still am not sure if I am on the drug have you had any side affects. Iam being treated for UC been off & on predisone so much I need to get off of it. I may be getting the drug every other month. Iam having a flare now so I hope the time comes that they will make sure Iam getting the drug And see if it does any good. I have had stiffness in my hands & hip area they are not sure if that is related to the drug. How soon after your infusion did you notice a difference? Iam glad I found someone on the drug I had know one to talk too. My next visit is 11-10 I just hope they find something that will work I would love to be able to go out to eat & not worry about being in the restroom.
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