Research Study in Patients With Severe Ulcerative Colitis - Full Text View

Sponsored by:	PDL BioPharma, Inc.
Information provided by:	PDL BioPharma, Inc.
ClinicalTrials.gov Identifier:	NCT00032305

Purpose

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	Intervention	Phase
Ulcerative Colitis	Drug: Visilizumab	Phase II Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Corticosteroids Visilizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids

Further study details as provided by PDL BioPharma, Inc.:

Estimated Enrollment:	20
Study Start Date:	March 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.
Active disease despite ongoing treatment with steroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

PDL BioPharma, Inc.

More Information

Website for information on all IBD trials sponsored by PDL This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Plevy S, Salzberg B, Van Assche G, Regueiro M, Hommes D, Sandborn W, Hanauer S, Targan S, Mayer L, Mahadevan U, Frankel M, Lowder J. A phase I study of visilizumab, a humanized anti-CD3 monoclonal antibody, in severe steroid-refractory ulcerative colitis. Gastroenterology. 2007 Nov;133(5):1414-22. Epub 2007 Aug 21.

Study ID Numbers:	291-406
Study First Received:	March 14, 2002
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00032305
Health Authority:	United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:

Colitis
Gastrointestinal Disease
Digestive System Disease
Intestinal Disease
Colonic Disease

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009