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

This study has been completed.

First Received on November 13, 2008. Last Updated on June 23, 2010 History of Changes

Sponsor:	University Hospital Case Medical Center
Collaborator:	Centocor, Inc.
Information provided by:	University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT00791557

Purpose

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	Intervention
Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease	Drug: Infliximab

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Ulcerative Colitis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	8
Study Start Date:	October 2008
Study Completion Date:	February 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Single arm open label	Drug: Infliximab IV drug given at weeks 1,2,14,22

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791557

Locations

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospital Case Medical Center

Centocor, Inc.

Investigators

Principal Investigator:

Neil J Korman, MD.PhD

University Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	Neil Korman, M.D., University Hospitals Case Medical Center
ClinicalTrials.gov Identifier:	NCT00791557 History of Changes
Other Study ID Numbers:	06-07-14
Study First Received:	November 13, 2008
Last Updated:	June 23, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Pyoderma
Ulcer
Pyoderma Gangrenosum
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases

Skin Diseases
Pathologic Processes
Skin Diseases, Vascular
Skin Ulcer
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012