An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

This study has been terminated.

Sponsored by:	PDL BioPharma, Inc.
Information provided by:	PDL BioPharma, Inc.
ClinicalTrials.gov Identifier:	NCT00355901

Purpose

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Visilizumab (Nuvion®; HuM291)	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Visilizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

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

Estimated Enrollment:	300
Study Start Date:	September 2006
Estimated Study Completion Date:	November 2012

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previous participation in a visilizumab study of IVSR-UC.
Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

Exclusion Criteria:

Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355901

Show 40 Study Locations

Sponsors and Collaborators

PDL BioPharma, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	291-420
Study First Received:	July 21, 2006
Last Updated:	August 2, 2008
ClinicalTrials.gov Identifier:	NCT00355901
Health Authority:	United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:

Ulcerative Colitis
Colitis
Steroid-Refractory
Visilizumab
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009