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

University Hospitals (UH)

Status: Completed

Conditions: Pyoderma Gangrenosum; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00791557

06-07-14

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Infliximab

Experimental group

Description:

Single arm open label IV Infliximab given at weeks 1,2,14,22

Treatment:

Drug: Infliximab