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.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: Visilizumab	Phase I

Further Study Details: 

Expected Total Enrollment:  20

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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

1) A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.

2) Active disease despite ongoing treatment with steroids

Clinical Trial Information Line      1-800-772-0482    infocenter@pdl.com

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  United States; Recruiting
      University of California, San Francisco,  California,  94115,  United States; Recruiting
Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  United States; Recruiting
Illinois
      The University of Chicago Medical Center, Chicago,  Illinois,  United States; Recruiting
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States
New York
      Mount Sinai School of Medicine, New York,  New York,  United States; Recruiting
Pennsylvania
      University of Pittsburgh School of Medicine, Pittsburgh,  Pennsylvania,  United States; Recruiting

Study ID Numbers:  291-406
Record last reviewed:  October 2003
Last Updated:  October 20, 2003
Record first received:  March 14, 2002
ClinicalTrials.gov Identifier:  NCT00032305
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08