Trial · NCT00760435
Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
NCT00760435, Phase 3, Completed, University of California, San Diego; results first posted 2014-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease. Trials, record NCT00760435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00760435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
- NCT number
- NCT00760435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Kawasaki Disease
- Interventions
- Infliximab, Placebo
- First posted
- 2008-09-26
- Last updated
- 2014-11-24
- Results first posted
- 2014-11-13
- Limitations and caveats
The major limitation of our study was the low rate of treatment-resistance in the placebo arm (11%, compared to historical IVIG resistance rates of 20%), which decreased our power to detect a difference in the primary outcome measure.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion | 10 weeks | |
| Secondary | Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks) | up to 6 weeks | |
| Secondary | Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm. | 24 hours | |
| Secondary | Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm | 2 weeks | left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion | 10 weeks | 1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo) | participants | NUMBER |
| SECONDARY | Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks) | up to 6 weeks | days | MEDIAN | |
| SECONDARY | Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm. | 24 hours | mg/dL | MEAN | |
| SECONDARY | Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm | 2 weeks | Z-score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion | Infliximab | 11 | participants | ||
| The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion | Placebo | 11 | participants | ||
| Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks) | Infliximab | 1 | Inter-Quartile Range 1 to 2 | days | |
| Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks) | Placebo | 2 | Inter-Quartile Range 1 to 2 | days | |
| Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm. | Infliximab | -6.6 | 95% Confidence Interval -7.7 to -5.4 | mg/dL | |
| Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm. | Placebo | -3.6 | 95% Confidence Interval -4.8 to -2.5 | mg/dL | |
| Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm | Infliximab | -0.605 | 95% Confidence Interval -0.808 to -0.403 | Z-score | |
| Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm | Placebo | -0.313 | 95% Confidence Interval -0.514 to -0.111 | Z-score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infliximab Arm | 98 | |
| Overall Study | STARTED | Placebo Arm | 98 | |
| Overall Study | COMPLETED | Infliximab Arm | 94 | |
| Overall Study | COMPLETED | Placebo Arm | 93 | |
| Overall Study | NOT COMPLETED | Infliximab Arm | 4 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 5 |
Source ClinicalTrials.gov
Adverse events30
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 | IVIG Infusion Reaction | Immune system disorders | Infliximab Arm | 0 | 98 | 0 |
| other | IVIG Infusion Reaction | Immune system disorders | Placebo Arm | 13 | 98 | 13 |
| other | Coronary artery abnormality | Cardiac disorders | Infliximab Arm | 5 | 98 | 5 |
| other | Coronary artery abnormality | Cardiac disorders | Placebo Arm | 11 | 98 | 11 |
| other | Rash | Skin and subcutaneous tissue disorders | Infliximab Arm | 6 | 98 | 6 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo Arm | 10 | 98 | 10 |
| other | URI | Infections and infestations | Infliximab Arm | 16 | 98 | 16 |
| other | URI | Infections and infestations | Placebo Arm | 19 | 98 | 19 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Infliximab Arm | 7 | 98 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Arm | 7 | 98 | 7 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infliximab Arm | ||
| Total, all-cause mortality | Placebo Arm | ||
| Total, other adverse events | Infliximab Arm | 49 | 98 |
| Total, other adverse events | Placebo Arm | 61 | 98 |
| Total, serious adverse events | Infliximab Arm | 22 | 98 |
| Total, serious adverse events | Placebo Arm | 17 | 98 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003514 | Phase III infliximab for primary treatment of Kawasaki disease IND 11046 6/27/200 | BURNS, JANE C | UNIVERSITY OF CALIFORNIA, SAN DIEGO | FOOD AND DRUG ADMINISTRATION | 2008 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Infliximab vs Placebo: The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion | Trial comparisons |
| Infliximab Arm vs Placebo Arm: serious adverse events | 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.
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/NCT00760435
GET https://conductscience.org/api/trials/v1/NCT00760435/events?page=2