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

This study is currently recruiting participants.

Verified by University Hospital Case Medical Center, March 2009

First Received: November 13, 2008 Last Updated: March 23, 2009 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:	Treatment, Open Label, Active Control, Single Group Assignment
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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Contacts

Contact: Kelly Jeffords, CCRC

216-983-0861

kelly.jeffords@uhhospitals.org

Locations

United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kelly Jeffords, CCRC 216-983-0861 kell.jeffords@uhhospitals.org
Principal Investigator: Neil J Korman, MD, PhD
Sub-Investigator: Jennifer D Bahner, MD

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:	University Hospitals Case Medical Center ( Neil Korman, M.D. )
Study ID Numbers:	06-07-14
Study First Received:	November 13, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00791557 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Skin Diseases, Vascular
Skin Diseases
Infliximab
Gastrointestinal Diseases
Pyoderma Gangrenosum
Colonic Diseases
Gastrointestinal Agents
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Pyoderma
Antirheumatic Agents
Skin Ulcer
Gastroenteritis
Dermatologic Agents
Colitis

ClinicalTrials.gov processed this record on February 08, 2010