I'm into Abatacept Trial - Stage 2 - But not happy!

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barnsbury
Regular Member


Date Joined Jan 2006
Total Posts : 479
   Posted 5/12/2008 11:17 AM (GMT -6)   
Hello everyone
 
OK, I just got back a short while ago from the hospital.  After my scope last week showed big improvement, I have now been placed into the second stage of the trial (maintainence).
 
I was randomised again.....and I am almost certain that this time I am in the PLACEBO group!!!
Oh no!!!!!!!!!!!!   I was really hoping and praying this wouldn't happen.
 
I had my infusion, and I just dont feel the same as I have done after my previous ones...I know this could all be in my head.  But, something just happened about 30 minutes ago that pretty much confirmed I have just had a placebo infusion - I HAD A BM !!!!!
 
I NEVER have a BM after an infusion. Even on Remicade days, I never did. So, now I am waiting to flare :-(  Terrible situation to be in.  But, all I can do is keep a close eye on my BMs and check extra carefully for blood.   If things start to worsen, I will call the hospital and ask to be put onto open-label.  But, I think they will make me go through yet another sigmoidoscopy first...sigh..
 
I will keep you all informed !
 
Take care
 
Abatacept Trial since Feb 2008 (Induction Period)
Back on Pred - 3mg - Steroid Dependent :-(
Azathioprine 175mg
Colazide x3
Actonel 35mg, EPA Fish Oils
Predfoam Enema - Had to stop as not allowed during trial
Asacol x 9, Lialda (Mezavant)
Remicade every 8 weeks  (Stopped working)
Aloe Vera Lily of the Desert Juice  Gave me the worst D !
Primadophilus Reuteri Probiotic
 


love4cats
Regular Member


Date Joined May 2007
Total Posts : 458
   Posted 5/12/2008 11:39 AM (GMT -6)   
Oh no, that is disappointing. Maybe it is just a coincidence.
 
 
Dx:  UC Proctitis 2006 
Meds:  None so far. Garlic works to ease flares. My GI laughed when I told him and said it was just coincidence. 
Started Meds:  Apr 9 08 500mg 5ASA (salofalk) to ease flare, tapering, stopped. 
Diet:  Regular fresh garlic, Biobest yogurt daily, Omega 3 supplements, very limited junk food, carbs and processed food, low fat diet.  Lots of fresh fruit and veggies (limited potatoes). 
 Added: tumeric and probiotics.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 30976
   Posted 5/12/2008 2:26 PM (GMT -6)   
Wow, interesting. Could it have been from what you ate the day before?

It sounds as though something stimulated your bowel.

Keep us posted as to how the week progresses.

Hoping this is just a one day thing.

quincy
*Heather*Status: mini flare Dec 28... tapered to every 4th night
~diagnosed January 1989 UC (proctosigmoiditis)
~5ASA: Asacol (6 daily) + Salofalk enemas (increase for flares tapered to maintenance)
~Bentylol (dicyclomine) 20mg as needed
~vitamins/minerals/supplements 
~Probiotic 3(Natural Factors Protec) bedtime + 1 (Primadophilus Reuteri) occasionally
~multi-digestive enzymes as needed ....zymactive 3 - 5x daily
~Ranitidine,Pariet (reflux) Effexor XR 75mg;  Pulmicort/Airomir (asthma)
~URSO for PSC (or PBC) 500mg X 2 daily (LFTs back to NORMAL!!)
My doc's logic.. "TREAT (FROM)BOTH ENDS"  worth it !!!


barnsbury
Regular Member


Date Joined Jan 2006
Total Posts : 479
   Posted 5/12/2008 3:04 PM (GMT -6)   

Quincy - No - I ate my normal bland food the day before, so it cant be that.

Plus, there are a few other things that just don't seem right.

Normally, after my infusion im very tired. Today, i have loads of energy.  Secondly, I always lose my apetite. Today, I was hungry on my journey home from the hospital, lol.

I am pretty certain it was a placebo.  It is disappointing but I cant really complain. I signed up for the trial, and this happening was always a possibility.

 


Abatacept Trial since Feb 2008 (Induction Period)
Back on Pred - 3mg - Steroid Dependent :-(
Azathioprine 175mg
Colazide x3
Actonel 35mg, EPA Fish Oils
Predfoam Enema - Had to stop as not allowed during trial
Asacol x 9, Lialda (Mezavant)
Remicade every 8 weeks  (Stopped working)
Aloe Vera Lily of the Desert Juice  Gave me the worst D !
Primadophilus Reuteri Probiotic
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 5/12/2008 8:49 PM (GMT -6)   
KSU, I’m sorry to hear that some symptoms are coming back. Please don’t compare Remicade to Abatacept. Other than both being given by infusion they are 2 completely different medications. When I was on Remicade I always felt tired and rundown after every infusion. With Abatacept I expected to feel the same. When I didn’t feel anything I was convinced I was on the placebo. When I went on the open label I also felt nothing. It was impossible for me to tell if I ever was on the placebo or not. I think it is still too soon for you to tell if the maintenance period is working or not. Give it time. At some point if it is not working you will be able to switch over to the open label.
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Bad reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Abatacept trial - no effect
 


barnsbury
Regular Member


Date Joined Jan 2006
Total Posts : 479
   Posted 5/13/2008 5:47 AM (GMT -6)   
Thanks Paul
 
You are right, it is far too soon for me to make conclusions yet. And I must admit, today has been a good day...so far..
 
Can you enter a new trial?  How is your UC now?
 
Did you know you can find out whether you got placebo or not in all stages of your trial, once you are off it. You can ask your GI to request the information from BMS.
 
Take care
Abatacept Trial since Feb 2008 (Induction Period)
Back on Pred - 3mg - Steroid Dependent :-(
Azathioprine 175mg
Colazide x3
Actonel 35mg, EPA Fish Oils
Predfoam Enema - Had to stop as not allowed during trial
Asacol x 9, Lialda (Mezavant)
Remicade every 8 weeks  (Stopped working)
Aloe Vera Lily of the Desert Juice  Gave me the worst D !
Primadophilus Reuteri Probiotic
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 5/14/2008 11:29 AM (GMT -6)   
KSU, I already tried 2 clinical trials and both failed for me. Since I didn’t respond to Remicade and I tested negative for antibodies I am not a candidate for other similar drugs such as Humira. My GI offered me a chance to enter a trial for the probiotic VSL#3 but I had already tried it with no results. I am tired of clinical trials. My current flare has lasted for more than 3 years. Next week for the first time I will see a colorectal surgeon to discus the possibilities.

I had emailed the study coordinator about finding out if I was on the Placebo and she responded with the following:

"The study is unblinded once the last patient has finished follow-up and that database is locked. Will be a long way off as study is still recruiting.”

This is how it is usually done with double blind studies. The patient and doctor cannot get that information until the entire study is over unless there is an emergency such as an adverse effect from the medication. When I was on the Adacolumn Apheresis study I was informed with a letter that I did receive the placebo. I received that letter about 1 ½ years after I stopped the study.
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Bad reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Abatacept trial - no effect
 

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