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.”
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