Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis
IRB#: 0608M91166
Trial Status: Open for enrollment
Phase: II/III
Sponsor: PDL BioPharma
Why is this study being done?
This research study is being done to find out if Visilizumab given after 5 days of steroids is effective at treating ulcerative colitis as compared to placebo.
Who is eligible to participate in the study?
Patients with severe ulcerative colitis who have failed oral steroid therapy or are newly diagnosed with ulcerative colitis. You must be hospitalized and receiving intravenous steroid therapy to be eligible for the study.
Minimum age: 18 years
Maximum age: none
What is involved in the study?
The study involves receiving an intravenous medication given on two consecutive days. As part of screening, you will be asked to undergo a flexible-sigmoidoscopy, blood work, stool studies, a urine pregnancy test, a chest x-ray and a physical exam. If you are eligible, you will undergo further studies in the hospital after receiving the study drug. This will be followed by periodic clinic evaluations (physician exams, one sigmoidoscopy, blood work) for the first 90 days and less frequent visits over the next 9 months. The entire study will last 12 months, but may be longer or shorter depending on your response.
How long will the study run?
You will be in the study for up to 12 months. The duration may be longer or shorter depending on your response.
Who can I contact to find out more about this trial?
If you are interested in participating in this study or would like additional information, please contact Matt Larson at (612) 625-6945.
What are the locations of this trial?
University of Minnesota Medical Center, Fairview – Minneapolis, Minnesota
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