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

History of Changes

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
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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
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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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
Number of Participants [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 ]

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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. ]

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Serious Adverse Events

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Other Adverse Events

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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.

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

No publications provided

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

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