An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
1 other identifier
observational
300
13 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2006
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2006
CompletedFirst Posted
Study publicly available on registry
July 25, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedAugust 5, 2008
August 1, 2008
July 21, 2006
August 2, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
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Worcester, Massachusetts, 01655, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Manhasset, New York, 11030, United States
Unknown Facility
Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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Cleveland, Ohio, 44106, United States
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Hershey, Pennsylvania, 17033, United States
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Charleston, South Carolina, 29425, United States
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Salt Lake City, Utah, 84107, United States
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Fremantle, 6160, Australia
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Liverpool, 2170, Australia
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Vienna, A-1090, Austria
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Ghent, B-9000, Belgium
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Leuven, 3000, Belgium
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Roeselare, 8800, Belgium
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Winnipeg, Manitoba, R3A-139, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Brno, Czechia
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Prague, Czechia
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Amiens, 80054, France
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Lille, 59037, France
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Paris, 75010, France
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Freiburg im Breisgau, D-79106, Germany
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Béri Balogh Adám, H-7100, Hungary
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Vác, H-2601, Hungary
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Vásvari Pál, H-9024, Hungary
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Dublin, Ireland
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Bologna, 40138, Italy
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Amsterdam, 1105 AZ, Netherlands
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Oslo, Norway
Unknown Facility
Tromsø, Norway
Unknown Facility
Kharkiv, 61001, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2006
First Posted
July 25, 2006
Study Start
September 1, 2006
Study Completion
November 1, 2012
Last Updated
August 5, 2008
Record last verified: 2008-08