An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
Terminated
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00355901
- Lead Sponsor
- PDL BioPharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method