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
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pyoderma Gangrenosum
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Intervention: Drug: Infliximab

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
  Hide More Information

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


No publications provided


Responsible Party: Neil Korman, 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