An Observatory Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steriod-Refractory Ulcerative Colitis
- Conditions
- Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)MedDRA version: 8.0Level: LLTClassification code 10045265
- Registration Number
- EUCTR2005-004105-28-HU
- Lead Sponsor
- PDL BioPharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1) Previous participation in a visilizumab study of IVSR-UC.
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
Exclusion Criteria
1) Unable to understand the purpose and risks of the study, or unwilling or unable to provide a 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