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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Neil Korman, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00791557
First received: November 13, 2008
Last updated: May 20, 2014
Last verified: May 2014

November 13, 2008
May 20, 2014
October 2008
December 2009   (final data collection date for primary outcome measure)
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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.
To determine the safety and efficacy of infliximab in pyoderma gangrenosum in adults subjects who have Inflammatory Bowel Disease [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00791557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pyoderma Gangrenosum
  • Crohn's Disease
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
Drug: Infliximab
IV drug given at weeks 1,2,14,22
Other Name: Remicade
Experimental: Infliximab
Single arm open label IV Infliximab given at weeks 1,2,14,22
Intervention: Drug: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00791557
06-07-14
No
Neil Korman, University Hospital Case Medical Center
University Hospital Case Medical Center
Centocor, Inc.
Principal Investigator: Neil J Korman, MD.PhD University Hospital Case Medical Center
University Hospital Case Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP