Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00221026|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Methoxsalen +ECP Procedure: Extracorporeal Photopheresis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
ECP + Uvadex given for 12 weeks.
Drug: Methoxsalen +ECP
ECP + Uvadex given at weeks 1-12 weeks.
Other Name: Uvadex
Procedure: Extracorporeal Photopheresis
ECP given at weeks 1 through 12.
Other Name: uvadex+ECP
- Crohns Disease Activity Index [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221026
|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|