Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
November 15, 2013
CompletedNovember 2, 2016
September 1, 2016
1.2 years
November 13, 2008
September 3, 2013
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Infliximab
EXPERIMENTALSingle arm open label IV Infliximab given at weeks 1,2,14,22
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.
- Have a history of serious infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals Cleveland Medical Centerlead
- Centocor, Inc.collaborator
Study Sites (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to timing of the study, only 2 subjects were enrolled.
Results Point of Contact
- Title
- Dr. Amanda Suggs, MD
- Organization
- University Hospitals of Cleveland
Study Officials
- PRINCIPAL INVESTIGATOR
Neil J Korman, MD.PhD
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 14, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
November 2, 2016
Results First Posted
November 15, 2013
Record last verified: 2016-09