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

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

 

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

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.

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.