Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. 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 over a 17 month period. 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 for Treatment of Perianal Fistulas in Patients With Crohn's Disease|
- Clinical response, defined as external closure of at least 50% of perianal fistulas, without an accompanying increase in dose of concomitant medications, the addition of new medications, or Crohn's Disease-related surgery.
- Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.