The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California
San Francisco, California, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
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Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States