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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 16, 2005
Last Updated Date	March 8, 2012
Start Date ^ICMJE	January 2004
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2006)	Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids
Original Primary Outcome Measures ^ICMJE (submitted: December 16, 2005)	Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids.
Change History	Complete list of historical versions of study NCT00267306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
Official Title ^ICMJE	A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids
Brief Summary	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.
Detailed Description	PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Severe Ulcerative Colitis
Intervention ^ICMJE	Drug: Visilizumab
Study Arm (s)	Not Provided
Publications *	Baumgart DC, Targan SR, Dignass AU, Mayer L, van Assche G, Hommes DW, Hanauer SB, Mahadevan U, Reinisch W, Plevy SE, Salzberg BA, Buchman AL, Mechkov GM, Krastev ZA, Lowder JN, Frankel MB, Sandborn WJ. Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitis. Inflamm Bowel Dis. 2010 Apr;16(4):620-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	144
Completion Date	December 2006
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00267306
Other Study ID Numbers ^ICMJE	291-408
Has Data Monitoring Committee	Not Provided
Responsible Party	Facet Biotech
Study Sponsor ^ICMJE	Facet Biotech
Collaborators ^ICMJE	PDL BioPharma, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Facet Biotech
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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