A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00336492
First received: June 9, 2006
Last updated: July 24, 2013
Last verified: July 2013
Results First Received: July 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ulcerative Colitis
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
No text entered.

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
Not Randomized Group Participants who were not randomized at Week 8
5 mg/kg Infliximab Every 8 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks

Participant Flow:   Overall Study
    Not Randomized Group     5 mg/kg Infliximab Every 8 Wks     5 mg/kg Infliximab Every 12 Wks  
STARTED     15     22     23  
COMPLETED     0     18     12  
NOT COMPLETED     15     4     11  
Adverse Event                 4                 3                 6  
Lack of Efficacy                 6                 1                 4  
Other                 5                 0                 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.
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Reporting Groups
  Description
Not Randomized Group Participants who were not randomized at Week 8
5 mg/kg Infliximab Every 8 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
Total Total of all reporting groups

Baseline Measures
    Not Randomized Group     5 mg/kg Infliximab Every 8 Wks     5 mg/kg Infliximab Every 12 Wks     Total  
Number of Participants  
[units: participants]
  15     22     23     60  
Age  
[units: years]
Mean ± Standard Deviation
  11.9  ± 2.64     13.7  ± 3.20     14.2  ± 3.03     13.4  ± 3.10  
Gender  
[units: participants]
       
Female     7     12     13     32  
Male     8     10     10     28  



  Outcome Measures
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1.  Primary:   The Number of Participants With Clinical Response at Week 8   [ Time Frame: Week 8 ]

2.  Secondary:   The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54   [ Time Frame: Week 54 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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: Senior Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research and Development
phone: 610-240-8092


No publications provided


Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00336492     History of Changes
Other Study ID Numbers: CR012388, C0168T72
Study First Received: June 9, 2006
Results First Received: July 14, 2011
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration