Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's disease. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site up to 17 months. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease|
- Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.
- Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267722
|United States, California|
|Inflammatory Bowel Disease Center|
|Los Angeles, California, United States, 90048|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|