Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2006|
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
|Principal Investigator:||Robert Lofberg, Prof.||IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden|
|Principal Investigator:||Toshifumi Hibi, Prof.||Keio University, Tokyo, Japan|