My Abatacept Trial Update

Wow, looks very positive for you that it is the abadacept. Congratulations that you're healing so well and on finally tapering to get off the pred. That in itself is a huge plus.

What do you mean getting rerandomised?

quincy

Congratulations KSU, It sounds like it is really working for you. I entered the study with a score of 9 and at the end of the induction period I had a score of 10. Unfortunately the open label didn’t work for me either.

Quincy, KSU just finished the Induction period of the study. The following is from the information I have from when I was on the study. It will explain the different phases of the study:

“Induction Period: If after the screening period, you qualify for the study, you will enter a 12-week Induction Period. This is a double-blind period which means neither you, nor the study doctor will know which dosing regimen you are receiving, except in an emergency. During this period, you will receive study medication on Days 1, 15, 29, and 57. You will randomly be assigned by chance (like the flip of a coin), to receive placebo, 3, 10 or 30/10 mg/kg abatacept in a double-blind manner. You will have a 29% (2 out of 7) chance of receiving placebo.

Maintenance Period: If you respond well to study treatment, you will be eligible to begin a 12-month Maintenance Period, where you will be randomly assigned to receive either abatacept (at a dose of 10 mg/kg) or placebo. You will have a 50% (1 out of 2) chance of receiving abatacept, and a 50 % (1 out of 2) chance of receiving placebo.

open-Label Period (optional): open-label means that during this period you will receive active drug (approximately 10 mg/kg) and the study will continue until abatacept is marketed for the treatment of ulcerative colitis or until BMS stops the study. You may enter the open-label period if you do not respond to the study medication after the Induction period or during the Maintenance period, or if you complete the Maintenance period.”

Thanks everyone.

Quincy, as Paul L states, on Monday my GI will make the all-important phone call to the study sponsors to get me assigned into either real medication or placebo.

Severin, To be honest with you, I dont actually think I will achieve full remission either. Nothing does that for me - except HIGH doses of steroids, and we all know how bad they are.

But, if Abatacept allows me to come off the pred without the usual end result of me drowning in blood in the bathroom, then I am happy.

Take care

Severin - It's great Abatacept allowed you to come off the pred.  I know you came off the trial due to not getting into remission. But, are you not concerned that without the Abatacept you may end up needing to go back onto pred?