Clinical trial NCT00073047: Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Gastrointestinal Disease
Inflammatory Bowel Disease
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease
Gastrointestinal
Humanized Monoclonal antibody
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Anaheim
country: United States
facility: Advanced Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Research Foundation of America
state: California
city: Los Angeles
country: United States
facility: Western Gastroenterology Group
state: California
city: Los Angeles
country: United States
facility: Cedar Sinai Medical Center
state: California
city: Gainesville
country: United States
facility: GVAMC
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Associates
state: Florida
city: Jacksonville
country: United States
facility: Physician Office
state: Florida
city: North Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Hospital
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Metairie
country: United States
facility: Drug Research Services, Inc.
state: Louisiana
city: Annapolis
country: United States
facility: Medlantic Investigators Network
state: Maryland
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: New York Center for Clinical Research
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastro Associates
state: South Carolina
city: Memphis
country: United States
facility: Memphis Gastroenterology Group, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research
state: Tennessee
city: S. Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Richmond GI Research Group
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References: