An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.
- Conditions
- Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC).MedDRA version: 8.0Level: LLTClassification code 10045265
- Registration Number
- EUCTR2005-004105-28-GB
- Lead Sponsor
- PDL BioPharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
1) Previous participation in an IVSR-UC visilizumab study.
2) Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Unable to understand the purpose and risks of the study, or unwilling or unable to provide signed and dated informed consent.
2) For U.S. sites, unwilling or unable to provide authorization to use protected health information.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method