The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. 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 Gastrointestinal Disease Inflammatory Bowel Disease	Drug: Daclizumab	Phase II

Further Study Details: 

Expected Total Enrollment:  150

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

• Moderate to severe active ulcerative colitis diagnosed for at least 4 months.
• Mayo score of 5-10 (inclusive)
• Not used any investigational therapy for 30 days prior to screening
• No treatment with monoclonal antibody therapy within 12 weeks of screening
• No prior treatment with daclizumab

Alabama
      Clinical Research Associates, Huntsville,  Alabama,  35801,  United States
California
      Advanced Medical Research Institute, Anaheim,  California,  92801,  United States
      Research Foundation of America, Los Angeles,  California,  90035,  United States
      Western Gastroenterology Group, Los Angeles,  California,  90045,  United States
      Cedar Sinai Medical Center, Los Angeles,  California,  90048,  United States
Florida
      Mount Sinai Medical Center, North Miami Beach,  Florida,  33162,  United States
      Clinical Research Associates, Hollywood,  Florida,  33021,  United States
      Physician Office, Jacksonville,  Florida,  32256,  United States
      GVAMC, Gainesville,  Florida,  32608,  United States
Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  30342,  United States
Illinois
      The University of Chicago Hospital, Chicago,  Illinois,  60637,  United States
Kentucky
      University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536,  United States
Louisiana
      Drug Research Services, Inc., Metairie,  Louisiana,  70001,  United States
Maryland
      Medlantic Investigators Network, Annapolis,  Maryland,  21401,  United States
Missouri
      St. Louis Center for Clinical Research, St. Louis,  Missouri,  63128,  United States
New York
      New York Center for Clinical Research, Lake Success,  New York,  11042,  United States
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195-0001,  United States
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States
Oklahoma
      Oklahoma Foundation for Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15261,  United States
South Carolina
      Columbia Gastro Associates, Columbia,  South Carolina,  29203,  United States
Tennessee
      Memphis Gastroenterology Group, P.C., Memphis,  Tennessee,  38120,  United States
      Nashville Medical Research, Nashville,  Tennessee,  37205,  United States
Vermont
      Fletcher Allen Health Care, S. Burlington,  Vermont,  05041,  United States
Virginia
      Digestive and Liver Disease Specialists, Norfolk,  Virginia,  23502,  United States
      Richmond GI Research Group, Richmond,  Virginia,  23230,  United States
      McGuire DVAMC, Richmond,  Virginia,  23249,  United States
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53207,  United States
Belgium
      Universitair Ziekenhuis Gasthuisberg, Leuven,  B3000,  Belgium
Canada, Alberta
      University of Alberta, Edmonton,  Alberta,  T6G 2C8,  Canada
Canada, British Columbia
      Vancouver General Hospital, Vancouver,  British Columbia,  V5Z1M9,  Canada
Canada, Ontario
      London Health Science Center, London,  Ontario,  N6A 5A5,  Canada
Canada, Quebec
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada

Study ID Numbers:  1008
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 14, 2003
ClinicalTrials.gov Identifier:  NCT00073047
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08