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Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00267306
First received: December 16, 2005
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.

What is visilizumab?

Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis.

Who can participate in this study?

The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics:

  • 16-70 year olds
  • 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

How is this study conducted?

Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

How does one get more information?

This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.


Condition Intervention Phase
Severe Ulcerative Colitis
Drug: Visilizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids

Estimated Enrollment: 144
Study Start Date: January 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16 -70 year olds
  • 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 IV steroids
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267306

Locations
United States, California
Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Weill Medical College of Cornell
New York, New York, United States, 10021
United States, Pennsylvania
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Facet Biotech
PDL BioPharma, Inc.
  More Information

Additional Information:
No publications provided by Facet Biotech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00267306     History of Changes
Other Study ID Numbers: 291-408
Study First Received: December 16, 2005
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014