Clinical Trial: Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: To determine the safety and efficacy of infliximab in pyoderma gangrenosum in adults subjects who have Inflammatory Bowel Disease [ Time Frame: Week 26 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: November 13, 2008
Date Started: October 2008
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016