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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 Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adacolumn Apheresis System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Name | Affiliation | Role |
|---|---|---|
| Robert Lofberg, Prof. | IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden | Principal Investigator |
| Toshifumi Hibi, Prof. | Keio University, Tokyo, Japan | Principal Investigator |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |