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

NCT ID: NCT00791557

Last Updated: 2016-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infliximab

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

Group Type EXPERIMENTAL

Infliximab

Intervention Type DRUG

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

Interventions

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Infliximab

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

Intervention Type DRUG

Other Intervention Names

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Remicade

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Neil Korman

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil J Korman, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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06-07-14

Identifier Type: -

Identifier Source: org_study_id