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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073047
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : July 20, 2009
Sponsor:
Information provided by:
Facet Biotech

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Gastrointestinal Disease Inflammatory Bowel Disease Drug: Daclizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab





Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073047


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Sponsors and Collaborators
Facet Biotech

Additional Information:
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Responsible Party: Nancy Teasdale, Director, Regulatory Affairs
ClinicalTrials.gov Identifier: NCT00073047     History of Changes
Other Study ID Numbers: 1008
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Facet Biotech:
Ulcerative Colitis
Inflammatory Bowel Disease
Gastrointestinal
Humanized Monoclonal antibody

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colonic Diseases
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Daclizumab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents