Research Study in Patients With Severe Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00032305
- Lead Sponsor
- Facet Biotech
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
University of California
🇺🇸San Francisco, California, United States
University of Pittsburgh School of Medicine
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States