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

NCT ID: NCT00073047

Last Updated: 2009-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis Gastrointestinal Disease Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Daclizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Facet Biotech

INDUSTRY

Sponsor Role lead

Locations

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Clinical Research Associates

Huntsville, Alabama, United States

Site Status

Advanced Medical Research Institute

Anaheim, California, United States

Site Status

Research Foundation of America

Los Angeles, California, United States

Site Status

Western Gastroenterology Group

Los Angeles, California, United States

Site Status

Cedar Sinai Medical Center

Los Angeles, California, United States

Site Status

GVAMC

Gainesville, Florida, United States

Site Status

Clinical Research Associates

Hollywood, Florida, United States

Site Status

Physician Office

Jacksonville, Florida, United States

Site Status

Mount Sinai Medical Center

North Miami Beach, Florida, United States

Site Status

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Site Status

The University of Chicago Hospital

Chicago, Illinois, United States

Site Status

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Drug Research Services, Inc.

Metairie, Louisiana, United States

Site Status

Medlantic Investigators Network

Annapolis, Maryland, United States

Site Status

St. Louis Center for Clinical Research

St Louis, Missouri, United States

Site Status

Long Island Clinical Research Associates

Great Neck, New York, United States

Site Status

New York Center for Clinical Research

Lake Success, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Consultants for Clinical Research

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Columbia Gastro Associates

Columbia, South Carolina, United States

Site Status

Memphis Gastroenterology Group, P.C.

Memphis, Tennessee, United States

Site Status

Nashville Medical Research

Nashville, Tennessee, United States

Site Status

Fletcher Allen Health Care

South Burlington, Vermont, United States

Site Status

Digestive and Liver Disease Specialists

Norfolk, Virginia, United States

Site Status

Richmond GI Research Group

Richmond, Virginia, United States

Site Status

McGuire DVAMC

Richmond, Virginia, United States

Site Status

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Site Status

Universitair Ziekenhuis Gasthuisberg

Leuven, , Belgium

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

London Health Science Center

London, Ontario, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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United States Belgium Canada

Other Identifiers

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1008

Identifier Type: -

Identifier Source: org_study_id

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