Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.
What is visilizumab?
Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis.
Who can participate in this study?
The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics:
- 16-70 year olds
- A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
- Active disease despite ongoing treatment with steroids
How is this study conducted?
Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.
How does one get more information?
This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids|
- Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids
|Study Start Date:||January 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267306
|United States, California|
|Inflammatory Bowel Disease Center|
|Los Angeles, California, United States, 90048|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|United States, Georgia|
|Atlanta Gastroenterology Associates|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Weill Medical College of Cornell|
|New York, New York, United States, 10021|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|UPHS/Presbyterian Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15261|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|