Trial · NCT00271570

Infliximab (Remicade) for Patients With Acute Kawasaki Disease

NCT00271570, Phase 1, Completed, University of California, San Diego; results first posted 2009-12-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Infliximab (Remicade) for Patients With Acute Kawasaki Disease. Trials, record NCT00271570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00271570

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Infliximab (Remicade) for Patients With Acute Kawasaki Disease
NCT number: NCT00271570
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: University of California, San Diego
Conditions: Kawasaki Disease
Interventions: Infliximab (Remicade), Intravenous immunoglobulin (IVIG)
First posted: 2006-01-02
Last updated: 2010-06-14
Results first posted: 2009-12-29

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)	2 weeks	The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.
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)	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.	The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 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. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)	2 weeks		events	NUMBER
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)	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.		micogram*day/ml	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)	IVIG Arm (2 gr/kg)	2		events
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)	Infliximab (5mg/kg)	3		events
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)	IVIG Arm (2 gr/kg)	0	Inter-Quartile Range 0 to 0	micogram*day/ml
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)	Infliximab (5mg/kg)	619	Inter-Quartile Range 458 to 891	micogram*day/ml

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IVIG Arm (2 gr/kg)	12
Overall Study	STARTED	Infliximab (5mg/kg)	12
Overall Study	COMPLETED	IVIG Arm (2 gr/kg)	12
Overall Study	COMPLETED	Infliximab (5mg/kg)	12
Overall Study	NOT COMPLETED	IVIG Arm (2 gr/kg)	0
Overall Study	NOT COMPLETED	Infliximab (5mg/kg)	0

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal distension	Gastrointestinal disorders	IVIG Arm (2 gr/kg)	1	12	1
other	Abdominal distension	Gastrointestinal disorders	Infliximab (5mg/kg)	0	12	0
other	Acute gastroentiritis	Gastrointestinal disorders	IVIG Arm (2 gr/kg)	1	12	1
other	Acute gastroentiritis	Gastrointestinal disorders	Infliximab (5mg/kg)	0	12	0
other	Allergic rash	Skin and subcutaneous tissue disorders	IVIG Arm (2 gr/kg)	1	12	1
other	Allergic rash	Skin and subcutaneous tissue disorders	Infliximab (5mg/kg)	0	12	0
other	Anemia	Blood and lymphatic system disorders	IVIG Arm (2 gr/kg)	2	12	2
other	Anemia	Blood and lymphatic system disorders	Infliximab (5mg/kg)	0	12	0
other	Ankle pain	Musculoskeletal and connective tissue disorders	IVIG Arm (2 gr/kg)	1	12	1
other	Ankle pain	Musculoskeletal and connective tissue disorders	Infliximab (5mg/kg)	0	12	0

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IVIG Arm (2 gr/kg)
Total, all-cause mortality	Infliximab (5mg/kg)
Total, other adverse events	IVIG Arm (2 gr/kg)	8	12
Total, other adverse events	Infliximab (5mg/kg)	10	12
Total, serious adverse events	IVIG Arm (2 gr/kg)	2	12
Total, serious adverse events	Infliximab (5mg/kg)	3	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
IVIG Arm (2 gr/kg) vs Infliximab (5mg/kg): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00271570

GET https://conductscience.org/api/trials/v1/NCT00271570/events?page=2

API reference For AI assistants