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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791557
First Posted: November 14, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center
Results First Submitted: September 3, 2013  
Study Type: Interventional
Study Design: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Infliximab

Single arm open label

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


Participant Flow:   Overall Study
    Infliximab
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Infliximab

Single arm open label

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


Baseline Measures
   Infliximab 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age, Customized 
[Units: Participants]
 
<=18 years   0 
Between 18 and 75 years   2 
>=75 years   0 
Gender 
[Units: Participants]
 
Female   0 
Male   2 


  Outcome Measures

1.  Primary:   The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease   [ Time Frame: Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to timing of the study, only 2 subjects were enrolled.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Amanda Suggs, MD
Organization: University Hospitals of Cleveland
phone: 216-844-7546
e-mail: Amanda.suggs@uhhospitals.org



Responsible Party: Neil Korman, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00791557     History of Changes
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