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NCT00073047 Clinical Trial

Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073047
Other study ID # 1008
Secondary ID
Status Completed
Phase Phase 2
First received November 14, 2003
Last updated July 17, 2009
Start date April 2003
Est. completion date July 2006

Study information
Verified date July 2009
Source Facet Biotech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Daclizumab

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

Sponsors (1)
Lead Sponsor Collaborator
Facet Biotech

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

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