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

August 2, 2008 updated by: PDL BioPharma, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fremantle, Australia, 6160
      • Liverpool, Australia, 2170
    • South Australia
      • Bedford Park, South Australia, Australia
    • Victoria
      • Box Hill, Victoria, Australia
  • Austria
      • Wien, Austria, A-1090
  • Belgium
      • Ghent, Belgium, B-9000
      • Leuven, Belgium, 3000
      • Roeselare, Belgium, 8800
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A-139
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
  • Czech Republic
      • Brno, Czech Republic
      • Praha, Czech Republic
  • France
      • Amiens Cedex, France, 80054
      • Lille, France, 59037
      • Paris, France, 75010
  • Germany
      • Freiburg, Germany, D-79106
  • Hungary
      • Béri Balogh Adám, Hungary, H-7100
      • Vac, Hungary, H-2601
      • Vásvari Pál, Hungary, H-9024
  • Ireland
      • Dublin, Ireland
  • Italy
      • Bologna, Italy, 40138
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
  • Norway
      • Oslo, Norway
      • Tromso, Norway
  • Ukraine
      • Kharkov, Ukraine, 61001
  • United States
    • California
      • San Francisco, California, United States, 94115
    • Florida
      • Gainesville, Florida, United States, 32610
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • New York
      • Manhasset, New York, United States, 11030
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Utah
      • Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PDL BioPharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion

November 1, 2012

Study Registration Dates

First Submitted

July 21, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 2, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291-420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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