Clinical trial NCT00355901: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Colitis
Steroid-Refractory
Visilizumab
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2006-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Worcester
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Manhasset
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Salt Lake City
country: United States
state: Utah
city: Bedford Park
country: Australia
state: South Australia
city: Box Hill
country: Australia
state: Victoria
city: Fremantle
country: Australia
city: Liverpool
country: Australia
city: Wien
country: Austria
city: Ghent
country: Belgium
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Brno
country: Czech Republic
city: Praha
country: Czech Republic
city: Amiens Cedex
country: France
city: Lille
country: France
city: Paris
country: France
city: Freiburg
country: Germany
city: Béri Balogh Adám
country: Hungary
city: Vac
country: Hungary
city: Vásvari Pál
country: Hungary
city: Dublin
country: Ireland
city: Bologna
country: Italy
city: Amsterdam
country: Netherlands
city: Oslo
country: Norway
city: Tromso
country: Norway
city: Kharkov
country: Ukraine
Study officials:
References: