Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
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.
Inflammatory Bowel Disease
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease [ Time Frame: Week 26 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|