Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.
Drug: Methoxsalen +ECP
Procedure: Extracorporeal Photopheresis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents|
- Crohns Disease Activity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.
|Study Start Date:||December 2004|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
ECP + Uvadex given for 12 weeks.
Drug: Methoxsalen +ECP
ECP + Uvadex given at weeks 1-12 weeks.
Other Name: UvadexProcedure: Extracorporeal Photopheresis
ECP given at weeks 1 through 12.
Other Name: uvadex+ECP
|United States, Maryland|
|Bethesda, Maryland, United States|
|Metropolitian Gastroenterology Group|
|Chevy Chase, Maryland, United States|
|United States, New Jersey|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States|
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States|
|General Hospital of Vienna|
|Universitat St Josef|
|Krankenhaus Duren gem.GmbH|
|University Hospital Munich-Grosshadem|
|Medizinische Universitatsklinik Ulm|
|Study Director:||dennis parenti, MD||Therakos|