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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00791557 |
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Date of registration:
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13/11/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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2 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00791557 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Neil J Korman, MD.PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospitals Cleveland Medical Center |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Pyoderma Gangrenosum
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Ulcerative Colitis
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Inflammatory Bowel Disease
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
[Time Frame: Week 26]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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