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

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ClinicalTrials.gov Identifier: NCT00791557
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : November 15, 2013
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pyoderma Gangrenosum
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Intervention Drug: Infliximab
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description

Single arm open label

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

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Infliximab
Hide Arm/Group Description

Single arm open label

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years 0
Between 18 and 75 years 2
>=75 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
1.Primary Outcome
Title The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
Hide 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
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Hide Analysis Population Description
Subjects who completed all required transfusions of infliximab were analyzed.
Arm/Group Title Infliximab
Hide Arm/Group Description:

Single arm open label

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

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab
Hide Arm/Group Description

Single arm open label

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

All-Cause Mortality
Infliximab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Infliximab
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Blood and lymphatic system disorders   
Infusion reaction   1/2 (50.00%)  1
Bone marrow suppression   1/2 (50.00%)  1
Infections and infestations   
Infection   1/2 (50.00%)  1
Indicates events were collected by systematic assessment
Due to timing of the study, only 2 subjects were enrolled.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amanda Suggs, MD
Organization: University Hospitals of Cleveland
Phone: 216-844-7546
EMail: Amanda.suggs@uhhospitals.org
Layout table for additonal information
Responsible Party: Neil Korman, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00791557    
Other Study ID Numbers: 06-07-14
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: September 3, 2013
Results First Posted: November 15, 2013
Last Update Posted: November 2, 2016