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

Primary Purpose

Pyoderma Gangrenosum, Crohn's Disease, Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infliximab
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infliximab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2008
Last Updated
September 27, 2016
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Centocor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00791557
Brief Title
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Centocor, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum, Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infliximab
Arm Type
Experimental
Arm Description
Single arm open label IV Infliximab given at weeks 1,2,14,22
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade
Intervention Description
IV drug given at weeks 1,2,14,22
Primary Outcome Measure Information:
Title
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil J Korman, MD.PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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