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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Neil Korman, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00791557
First received: November 13, 2008
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pyoderma Gangrenosum
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Drug: Infliximab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab
Single arm open label IV Infliximab given at weeks 1,2,14,22
Drug: Infliximab
IV drug given at weeks 1,2,14,22
Other Name: Remicade

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791557

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Centocor, Inc.
Investigators
Principal Investigator: Neil J Korman, MD.PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Neil Korman, Principle Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00791557     History of Changes
Other Study ID Numbers: 06-07-14
Study First Received: November 13, 2008
Results First Received: September 3, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Pyoderma
Pyoderma Gangrenosum
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014