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

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ClinicalTrials.gov Identifier: NCT00791557
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : November 15, 2013
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center

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.


Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease Drug: Infliximab Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Infliximab
Single arm open label IV Infliximab given at weeks 1,2,14,22
Drug: Infliximab
IV drug given at weeks 1,2,14,22
Other Name: Remicade



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791557


Locations
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Centocor, Inc.
Investigators
Principal Investigator: Neil J Korman, MD.PhD University Hospitals Cleveland Medical Center

Responsible Party: Neil Korman, Principle Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00791557     History of Changes
Other Study ID Numbers: 06-07-14
First Posted: November 14, 2008    Key Record Dates
Results First Posted: November 15, 2013
Last Update Posted: November 2, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Pyoderma
Pyoderma Gangrenosum
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents