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Infliximab (Remicade) for Patients With Acute Kawasaki Disease

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00271570
First received: December 30, 2005
Last updated: June 11, 2010
Last verified: November 2009
Results First Received: May 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kawasaki Disease
Interventions: Drug: Infliximab (Remicade)
Biological: Intravenous immunoglobulin (IVIG)

  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
IVIG Arm (2 gr/kg) 2nd dose of IVIG (2gr/kg)
Infliximab (5mg/kg) Remicade (Infliximab Arm of 5mg/kg)

Participant Flow:   Overall Study
    IVIG Arm (2 gr/kg)   Infliximab (5mg/kg)
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  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
IVIG Arm (2 gr/kg) 2nd dose of IVIG (2gr/kg)
Infliximab (5mg/kg) Remicade (Infliximab Arm of 5mg/kg)
Total Total of all reporting groups

Baseline Measures
   IVIG Arm (2 gr/kg)   Infliximab (5mg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
     
<=18 years   12   12   24 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 1.833  (.3)   1.667  (.3)   1.75  (.3) 
Gender 
[Units: Participants]
     
Female   3   4   7 
Male   9   8   17 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures
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1.  Primary:   Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)   [ Time Frame: 2 weeks ]

2.  Primary:   Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)   [ Time Frame: before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. ]


  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
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  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.


Results Point of Contact:  
Name/Title: Jane Burns, MD, Professor
Organization: University of California, San Diego
phone: 858-246-0155
e-mail: jcburns@ucsd.edu



Responsible Party: Jane C. Burns, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00271570     History of Changes
Other Study ID Numbers: 041374
2004-0548
Study First Received: December 30, 2005
Results First Received: May 1, 2009
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration