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Research Study in Patients With Severe Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00032305
Recruitment Status : Completed
First Posted : March 18, 2002
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Facet Biotech

Brief Summary:
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. 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 Drug: Visilizumab Phase 2 Phase 3

Detailed Description:
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
Study Start Date : March 2002
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.
  2. Active disease despite ongoing treatment with steroids

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): NCT00032305


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California
San Francisco, California, United States, 94115
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Facet Biotech

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00032305     History of Changes
Other Study ID Numbers: 291-406
First Posted: March 18, 2002    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Facet Biotech:
Colitis
Gastrointestinal Disease
Digestive System Disease
Intestinal Disease
Colonic Disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases