Trial record 17 of 31 for:    "Kawasaki syndrome"

Infliximab (Remicade) for Patients With Acute Kawasaki Disease

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. Identifier: NCT00271570
Recruitment Status : Completed
First Posted : January 2, 2006
Results First Posted : December 29, 2009
Last Update Posted : June 14, 2010
Centocor, Inc.
Information provided by:
University of California, San Diego

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kawasaki Disease
Interventions: Drug: Infliximab (Remicade)
Biological: Intravenous immunoglobulin (IVIG)

  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
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 

  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
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 
[Units: Participants]
<=18 years   12   12   24 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 1.833  (.3)   1.667  (.3)   1.75  (.3) 
[Units: Participants]
Female   3   4   7 
Male   9   8   17 
Region of Enrollment 
[Units: Participants]
United States   12   12   24 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Jane C. Burns, University of California, San Diego Identifier: NCT00271570     History of Changes
Other Study ID Numbers: 041374
First Submitted: December 30, 2005
First Posted: January 2, 2006
Results First Submitted: May 1, 2009
Results First Posted: December 29, 2009
Last Update Posted: June 14, 2010