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

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.

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Key information

Conditions

Pyoderma Gangrenosum Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Pyoderma Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Drug

IV drug given at weeks 1,2,14,22

Other names: Remicade

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

Centocor, Inc.

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Nov 14, 2008
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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