The Adacolumn phase 3 studies for UC in North America ended a few years ago. I participated in the study hear in Toronto. I had 12 treatments in the first part of the study and later found out that I had the placebo. I then went on the
open label (actual treatment) and had another 17 treatments with no improvement in symptoms. When the study was over I received a letter telling me I was on the placebo and that the effectiveness of the treatment compared to the placebo was only slightly better and as a result the treatment will not be approved for use in Canada and the US.
After talking to my GI about
it he gave me several reasons why the study may not have worked out in North America but was fine in Japan.
1. UC in Japan may be slightly different then in North America.
2. The Adacolumns were manufactured in the US and may be slightly different than in Japan.
3. The Testing in North America may be more rigorous.
My GI said if they do find a reason they may correct it if possible and conduct more studies in North America.
Diagnosed in 2000 at age 43 with UC. Colon removed October 20/08.
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