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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!

My Butt Hurts

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.
He/she's in Rochester, not Buffalo.

Welcome, and good luck in the trailblazing of a potential new med for Crohns.

My Butt Hurts

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.
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!
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!
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!
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 :(.
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?
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.
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.
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.
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!
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.
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!
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.
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!
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!
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!
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!
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!!
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!
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.

shmooda said:
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.
Good luck buddy - let us know how you are doing with it and *thank you* for doing a clinic trial - we all need more people like you doing those tests for us to get new medications!
Well....hang in there - hopefully you'll start seeing some results soon! How long does your trial go on for do you know?

in my hospital there are 10 patients on these drugs. ..I'm in touch with 2 of them and they are getting better! nobody is getting worse



I am new here. I have UC (10 years) and have just had my first MLN002 infusion this past Monday as part of the trial. I am in England.

I haven't noticed any improvement, nor any side effects. Though, I do notice the odd time during the day when I suddenly get really fatigued and a bit brain foggy....

I am hoping I am not on the placebo! I am the only one on the trial at my hospital, so its great that I have found you guys! So, we can discuss our experiences!

I have my 2nd infusion in 2 weeks, then another flex sig at week 6.

Take care

Hey there Steve,

I'm in Dublin... I'm going in for my initial screening for the trial on Wednesday. I've been told that there is no placebo being used by the hospital. There will be two doses and I will not know which one I am on...

I'll keep you posted with any news! Apparently, the drug has to build up in the system first hence the 3 * 2 week doses followed by monthly doses so it might take a few weeks to notice a substantive change in symptoms.

Fingers crossed everyone and I hope you start feeling a bit better soon, Steve.


oregon said:

I am new here. I have UC (10 years) and have just had my first MLN002 infusion this past Monday as part of the trial. I am in England.

I haven't noticed any improvement, nor any side effects. Though, I do notice the odd time during the day when I suddenly get really fatigued and a bit brain foggy....

I am hoping I am not on the placebo! I am the only one on the trial at my hospital, so its great that I have found you guys! So, we can discuss our experiences!

I have my 2nd infusion in 2 weeks, then another flex sig at week 6.

Take care

Hi Nick

Hope all is well.

Did you have your screening? How did it go? Good I hope!

Wow, lucky you at a hospital with no placebo! Wish I had that, lol. However, I am 99.9% sure I am on the real drug.

I have just had my 2nd infusion this week. So, thats the introduction phase over with. I have my flex sig arranged for Week 6, which is when I will be re-assigned. I really hope I stay on the drug!

I have noticed a small improvement in symptoms. Fewer BMs, less bleeding. Though still have urgency.

I used to be in Dublin all the time! Have friends living there.

Good luck, and keep us informed!


Hi I'm currently in hospital due too a bad flare of cd
I was diagnosed about 5years ago and was travelling along not too bad considering up until 5 months ago since then nothing has been able too slow or control it

I've been on immuran 200mg. Mesalazine 1500mg. Fish oil tablets. Multi vitamins. Predniscilone 50mg and 4g mesalazine enima

currently in hospital I'm recieving hydeoquatazone injections and a anti blood clotting injection. Plus a antibiotic and a vitamin d plus calcium tablet

I eat more pills than food lol

I went on remicade reccently but absolutly no change

so now my specialist is suggesting a trial of two new drugs

vedolizumab mln0002. An the other is ustekinumab

now the vedo is an open label trial so no placebo I'll get the actual drug
where the ustek is a placebo trial so no gaurentee I'll get the drug

I'm not sure which way too go spec seein I hav limited info

so I'm Layin in bed searchin up the drugs on my iPhone (how I found this forum)
(please excuse the spelling as the iPhone bit clumsy Or me lol)

so any help guiding me would be appreciated


Crohn's 35

Inactive Account
Hi Rob and welcome!!!!! It would be best if you put your story on a MY story thread so everyone here can greet you! There is so much information here, and we have a laugh or two , goodness knows we have enough bad days as you are having. I really hope you get some relief soon... hope you are getting the real stuff!

Hope you stick around, and join us!

Crohn's 35

Inactive Account
Some one help this poor guy.. but I will try. Go to the original board where it has categories and click on MY Story and then click on Threads and put your story on here... I am a not computer techie either but hope this helps....
Hey Rob - we'd love to get your full story - but since you are having to "thumb" it with an iPhone (thank goodness you at least have that!!) - you are fine with what you have written here.

I have never been a part of a clinical trial before and I guess it would depend on how severe my disease was. My inclination would be to go on the trial where I *knew* I was getting the actual drug so that I would have a good chance of getting a response and quieting my disease down as quickly as possible. But - participating in blind trials are very important as well.....so...I guess it is still a personal choice eh?

We have threads for both of those drugs - would you please keep us posted on what you decide to do and how you respond to them? It would be very helpful to users of this forum. Good luck to you and I hope you start feeling better soon!
Hi all!!

last week I had colonscopy after 6 week of vedolizumab

I had a moderate colitis, but now it's become slightly!!

Now i go to the bathroom less frequently

next infusion: 24 feb
How goes the treatment Ezio?

My drs offering this drug to me but jus don't hav much info on it
the possible side effects is another worry
that plm or pml what ever it is

if I decide too go for this drug trial I'll be garaunteed 100% too recieve it

I just need too decide if I want too try it or go the operation route or try a diff drug trial that possibly won't get me the drug jus a placebo
This drug in _theory_ has a reduced chance of causing PML because it targets a protein more specific to the digestive system. Tysabri targets the same protein, but also is less specific and targets other proteins believed to be important in the brain. The idea is that we know Tysabri works, so if we more specifically target the protein that treats crohns disease while not (or minimally) targetting the protein that is involved in PML, we can create a drug with the same benefits, but reduced risk of PML.

As for your concern of going into the placebo vs open trial, only you can decide that. Does the placebo trial have a period where they can unblind you after 8 or 12 weeks if you don't improve so you can get the drug if you were on placebo? If so that changes how I would respond. Right now your goal should be to save your colon (or at least mine would be if I were that bad) so you need to take the route you feel will allow you to do that OR to accomplish whatever your personal goals are.
Not a doctor, just a chemical biology/molecular biology grad student. Hopefully my input will help you make the right decision for you based on your needs and the information available to you.
Ok cool

any input an advice greatly appreciated

I've been given til tomorrow to decide what I wish to do

do the MLN0002 vedolizumab trial
or do the ustekinumab trial
or hav surgery an live with a bag, a re section can't be done

do you know of any advantages of either of the two drugs over the other?
I believe ustekinumab goes after a new target that hasn't previously been used to treat crohns, but a couple companies are working on drugs for it (not 100% certain and don't have time to look up which companies and how many and what target). MLN0002 has the previous knowledge the tysabri works, but _should_ be free of the risks of the side effects, but until enough people take the drug and in various combinations with other therapies, we cannot be certain. The last choice you should ever make (at least in my book) is a permanent surgery leading to an ostomy when you have other options available to you. Even with an ostomy, your lifestyle has to change significantly and you are prone to other issues that can cause pain and discomfort, so it isn't a perfect solution either.

My personal choice would be the open label trial since it sounds like you are in bad shape right now. You need some form of medication more than the chance of getting it. If I were in your shoes, that is how I would chose. The other thing to look at are the trial inclusion/exclusion criteria. What dose of pred do you have to be on before you can enter? For how long? How long do you have to be off other biologics (i.e. remicade/humira)? For how long? A lot of trials are fairly standardized, but you might have to wait 2+ months to enter either trial simply based on your current medications. Also, find out if after 8-12 weeks you get your trial group switched in the double blind random trial. Or if you can be switched to the drug if you are on placebo after 8-12 weeks and your condition is worsening and you would be forced to exit the trial otherwise. These are all very important details about both trials and their design that you should know before entering the trial. Also, depending on your age, do you want to have kids in the next ~2 years? Many drugs request you to not have kids during their duration and for a period after due to the unknown effects on unborn children. If you do have a kid, then you have to be closely monitored (which in some ways helps them to study the drug effects on developing babies, but do you want to take that risk?). I think I covered most of the things I considered when I tried to get into a couple clinical trials. Good luck with your decision and let us know which one you chose.
*spot on* to what Said mentioned above Rob. Just about covered it all there. And - if it were me - I would choose the Vedo trial if they don't have to double blind you at some point. If I had super active disease, I would want drug *now* to try and save what bowel I have for as long as possible (unless there is just no chance for it to become healthy again).
Thanks for all the info an help guys

I'm most prob going the direction of the vedo trial so I know I get the medication straight off

there is a chance after 6-8 weeks I think that I could be placed onto a placebo too see if it is working etc
but that's still 6-8 weeks of recieving the drug an according too the paper work there is a small loop I think where if you begin too decline from the placebo they may reintroduce the drug again ???? ( not 100%) either way I'd rather know I recieving a drug than too not know (usteki trial)

the way I see it if this drug fails I stil can fall back on the ostomy surgery at any point anyway
but once I go that route can't go back

so looks like we gained another guinee pig for mln0002. Lol
Good luck and let us know how you do with it. Tysabri really helped me for a while, but after 5-6 months I couldn't handle the worry about PML developing. I think MLN0002 should be free of that concern since it is a better targeted drug.
Not to steal your thunder here Rob but I as well am starting on Vedo on the 18th. If you want, I could update my status as well that way other people who are considering this drug will have some sort of real life "testimony" as to if it helps or not. I'm hoping this is the one for me because its bye bye Colon if not :(

Later and Good luck Rob and Ezio!
Be my guest at the thunder lol

but seriously yea it's great too know a few people doin this drug
if or when i get onto the trial it will be great too bounce experiences/problems etc off of

the more we know etc the better off we can all be

I'm seriously hopin i get onto this drug an that it's the one for me
I've already tried remicade an that failed
I'm on immuran and salafalk aswell as predniscilone and that's not working
I'm on high dose of hydrocortisone ATM (only thing keepin me stable right now) but i can't stay on this as it's a hospital administered drug only here and 2 there are too many side effects

So once I come off it I'll begin the rapid spiral down again
an that will then result in surgery an a bag for me

so if you or anyone else wishes too assist with information - I'm all ears
and once I know more an somethin that may of be assistance to others I'll be happy too share
"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."
I think he is right.
Hmmm - I have been on Remi over 6 years and have never experienced any off taste in my mouth from it.

Lucy - you need to remove your advertising from your signature please - it is not allowed on this forum.
Hey everyone, just letting you know I started the trial yesterday and got my first dose. Everything went well but I felt a little tired afterward...although, i did forget my pred yesterday morning so that may be why too. I'm not feeling a difference yet as far as my inflammation and i'm sure its too early but I have had a ton of energy today which has been my biggest battle. I've got another infusion March 10th. Thanks to everyone on this forum for providing a place for us Crohnies to come and talk about the three biggest things in a Chronies life....Medication, Food, and Poo :p

I'll keep you guys up to date :D
yesterday i have my 5^ infusion.
Now i stay better than november (before to start the trial) but now i dont stay well than one month ago...
Ah bugga

hope it's jus a minor set back for you an things improve again

approx 2-3 weeks an hopefully I'll be on this trial too
hi all!!

i didn't improve since the trial started. Maybe the next week I'll start mesalazine mmx (which is on sale since january here in italy)
bad news:

in last weeks i lost every benefit from vedolizumab so i go out from the trial.

my actually drugs is predisone...
I'm starting MLN0002 tomorrow...

Hi Shmooda,
glad to see that someone is having good success on this trial. I start tomorrow. I was on Remicade for 3 years- worked like a charm. Then, it quit working. Humira didn't work and I had a bad injection site reaction... so this is where I'm at.... I'm glad to see that it's having good success for some. Again, I could be on the placebo or the drug, fingers and toes are crossed it's the drug. I'd love to heave from anyone else on the trial....?
Ezio - Sorry to hear that Vedolizumab stopped working for you.

Jenthegr8 - Good luck with the trial.

I have been on the trial for almost 18 months now. I have been on open label since January 2011. I have been doing really well. I am off steroids for the first time in 8 years (since November 2010). It is a miracle for me.

I have really bad UC and nothing except high dose pred has worked in the past 10 years.

It is worrying when I hear of people for whom the drug has stopped working. There is one other patient at my hospital who has crohns and she is doing quite well.

Keep us informed Jen about your experiences!

Best wishes
@oregon, glad this drug is working for you, hope it continues to work for you.. I also wanted to go on trial (unfortunately, it's not open-label). Has this drug put you in complete remission? Have you experienced any side effects?
gt91 - Yes, it has put me into remission. My only symptom now is mild urgency first thing in the morning. But, I can live with that. I have tried every drug for UC/Crohns out there, including other trials and nothing ever worked. It saved me from surgery.

I havent had too many side effects. The main one is insomnia the day after the infusion (but only mild). And I used to get strange dreams, but that seems to have stopped now. I got some neck pain now and then but I haven't noticed that either lately.

If you don't see an improvement after the first 3 infusions, you go straight onto open label.

Hope this helps,

Best wishes