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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 October 2017
Main ID:  NCT00791557
Date of registration: 13/11/2008
Prospective Registration: Yes
Primary sponsor: University Hospitals Cleveland Medical Center
Public title: Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Scientific 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
Date of first enrolment: October 2008
Target sample size: 2
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  N/A
Countries of recruitment
United States
Name:     Neil J Korman, MD.PhD
Affiliation:  University Hospitals Cleveland Medical Center
Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Pyoderma Gangrenosum
Ulcerative Colitis
Drug: Infliximab
Primary Outcome(s)
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease [Time Frame: Week 26]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor, Inc.
Ethics review
Results available: Yes
Date Posted: 15/11/2013
Date Completed:
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