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

Stopped early

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00355901

Run by

PDL BioPharma, Inc.

People needed

300

Starts

2006-09-01

Expected to finish

2012-11-01

Last updated by the study team

2008-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Louisville, Kentucky, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Manhasset, New York, United States
• Study site — Mineola, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Bedford Park, South Australia, Australia
• Study site — Box Hill, Victoria, Australia
• Study site — Fremantle, Australia
• Study site — Liverpool, Australia
• Study site — Vienna, Austria
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Roeselare, Belgium
• Study site — Winnipeg, Manitoba, Canada
• Study site — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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