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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791557
• Other study ID #: 06-07-14
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: May 20, 2014
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: May 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must Be ages 18-75

• Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum

• Must never have received Infliximab for the treatment of pyoderma gangrenosum

Exclusion Criteria:

• Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.

• Have a history of serious infections

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pyoderma
• Pyoderma Gangrenosum
• Ulcerative Colitis

Intervention

Drug:
• Infliximab
IV drug given at weeks 1,2,14,22

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease	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.	Week 26	No