- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00791557
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
September 27, 2016 updated by: Neil Korman, University Hospitals Cleveland Medical Center
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infliximab
Single arm open label IV Infliximab given at weeks 1,2,14,22
|
IV drug given at weeks 1,2,14,22
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Neil J Korman, MD.PhD, University Hospitals Cleveland Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
November 13, 2008
First Submitted That Met QC Criteria
November 13, 2008
First Posted (Estimate)
November 14, 2008
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-07-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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