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

University Hospitals Cleveland Medical Center2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease

Interventions

InfliximabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease

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.

Time frame: Week 26

Data from ClinicalTrials.gov

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