Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel 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: NCT00791557|
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : November 15, 2013
Last Update Posted : November 2, 2016
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.
This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.
|Condition or disease||Intervention/treatment||Phase|
|Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease||Drug: Infliximab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||February 2010|
Single arm open label IV Infliximab given at weeks 1,2,14,22
IV drug given at weeks 1,2,14,22
Other Name: Remicade
- The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease [ Time Frame: Week 26 ]Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.
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): NCT00791557
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Neil J Korman, MD.PhD||University Hospitals Cleveland Medical Center|