Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724958
First received: July 25, 2008
Last updated: October 11, 2013
Last verified: October 2013
Results First Received: July 13, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Crohn's Disease
Intervention: Biological: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Remicade Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.

Participant Flow:   Overall Study
    Remicade  
STARTED     348  
COMPLETED     166  
NOT COMPLETED     182  
Adverse Event                 28  
Loss of Response                 40  
No Response                 18  
Remission                 7  
Other Reason                 76  
No documentation for end of therapy                 13  



  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.
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Reporting Groups
  Description
Remicade Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.

Baseline Measures
    Remicade  
Number of Participants  
[units: participants]
  343  
Age  
[units: years]
Mean ± Standard Deviation
  38.68  ± 12.30  
Gender  
[units: participants]
 
Female     178  
Male     165  
Region of Enrollment  
[units: participants]
 
Austria     343  



  Outcome Measures
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1.  Primary:   Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)   [ Time Frame: up to 2 years ]

2.  Primary:   Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)   [ Time Frame: up to 2 years ]

3.  Primary:   Average Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

4.  Primary:   Median Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

5.  Primary:   Total Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

6.  Secondary:   Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724958     History of Changes
Other Study ID Numbers: P04052
Study First Received: July 25, 2008
Results First Received: July 13, 2011
Last Updated: October 11, 2013
Health Authority: Austria: No HA submission required