Trial · NCT00841789
A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
NCT00841789, Phase 2, Completed, Michael Portman; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease. Trials, record NCT00841789. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00841789
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
- NCT number
- NCT00841789
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 205 participants, actual
- Lead sponsor
- Michael Portman
- Conditions
- Mucocutaneous Lymph Node Syndrome, Kawasaki Disease
- Interventions
- Etanercept, Placebo
- First posted
- 2009-02-11
- Last updated
- 2023-05-06
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IVIG Refractory | 42 days after initial dose | The primary outcome is the proportion of subjects who become refractory to IVIG. Subjects requiring 1 dose of IVIG are classified as responders and subjects requiring more than 1 dose are classified as IVIG refractory. |
| Secondary | Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro | 42 days after initial dose | The primary echocardiographic outcome will be the proportion of subjects with improvement defined as (20% change in coronary artery) from the worst findings during the acute study period (scheduled visits from admission to visit 4, including any unscheduled visits) to the primary study outcome time-point at visit 5 (visit 5). This calculation will be based on changes in absolute values and not z-scores as initially planned. Groups will be compared using a logistic model including a binary term for age \< versus \> 1 year. Two aspects of the echo findings will be considered: * Maximum aneurysm size and * Maximum measurements for left main coronary artery (LMCA), left anterior descending artery (LAD) and right coronary artery (RCA). * Change in diameter of each coronary artery will be determined at standard measurement location or aneurysm with the latter taking precedent. |
| Other | Change in Coronary Artery Dimension by z Score Compared With General Estimating Equation | 6 weeks | Overall change in coronary z score over time determined using General Estimating Equation in patients from baseline within patients. No change or improved defined by 20% change in z score. A Z score normalized for body surface area represents how much larger (or smaller) a measured coronary artery internal diameter by echocardiography is compared to the average coronary artery diameter for a child of the same size (body surface area includes both height and weight). There is no minimum or maximum value. Z score above 2.0 is at least 2 standard deviations above mean for population and is considered abnormal. A decrease in z score is favorable. |
| Other | Overall Change in z Score Over Time in Patients With Dilated Coronary Artery at Baseline Within Patients. | 6 weeks | Overall change in z score over time determined using General Estimating Equation in patients with dilated coronary artery at baseline within patients. Overall change in coronary z score over time determined using General Estimating Equation in patients from baseline within patients. A Z score normalized for body surface area represents how much larger (or smaller) a measured coronary artery internal diameter by echocardiography is compared to the average coronary artery diameter for a child of the same size (body surface area includes both height and weight). There is no minimum or maximum value. Z score above 2.0 is at least 2 standard deviations above mean for population and is considered abnormal. A decrease in z score is favorable. |
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 | IVIG Refractory | 42 days after initial dose | All patients receiving study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro | 42 days after initial dose | All patients receiving study drug with coronary measures improved | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Coronary Artery Dimension by z Score Compared With General Estimating Equation | 6 weeks | Includes patients categorized by baseline coronary artery dilation (echocardiography) with stable or improved coronary artery z score | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Overall Change in z Score Over Time in Patients With Dilated Coronary Artery at Baseline Within Patients. | 6 weeks | KD patients with dilated coronary arteries at baseline (improved or stable) | score on a scale | 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 |
|---|---|---|---|---|---|
| IVIG Refractory | Arm 1 -Etanercept | 13 | Participants | ||
| IVIG Refractory | ARM 2 Placebo | 22 | Participants | ||
| Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro | Arm 1 -Etanercept | 56 | Participants | ||
| Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro | ARM 2 Placebo | 53 | Participants | ||
| Change in Coronary Artery Dimension by z Score Compared With General Estimating Equation | Arm 1 -Etanercept | -0.4 | Standard Error .122 | units on a scale | |
| Change in Coronary Artery Dimension by z Score Compared With General Estimating Equation | ARM 2 Placebo | -0.10 | Standard Error 0.159 | units on a scale | |
| Overall Change in z Score Over Time in Patients With Dilated Coronary Artery at Baseline Within Patients. | Arm 1 -Etanercept | -081 | Standard Error 0.39 | score on a scale | |
| Overall Change in z Score Over Time in Patients With Dilated Coronary Artery at Baseline Within Patients. | ARM 2 Placebo | 0.4 | Standard Error 0.81 | score on a scale |
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 | Arm 1 -Etanercept | 103 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | COMPLETED | Arm 1 -Etanercept | 98 | |
| Overall Study | COMPLETED | Placebo | 99 | |
| Overall Study | NOT COMPLETED | Arm 1 -Etanercept | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Skin Rash | Skin and subcutaneous tissue disorders | Arm 1 -Etanercept | 10 | 99 | 10 |
| other | Skin Rash | Skin and subcutaneous tissue disorders | Arm -2 Placebo | 12 | 102 | 12 |
| serious | Hospital readmission for retreatment | Immune system disorders | Arm 1 -Etanercept | 7 | 99 | 7 |
| serious | Hospital readmission for retreatment | Immune system disorders | Arm -2 Placebo | 10 | 102 | 10 |
| serious | Infection | Infections and infestations | Arm 1 -Etanercept | 2 | 99 | |
| serious | Infection | Infections and infestations | Arm -2 Placebo | 0 | 102 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 -Etanercept | 0 | 99 |
| Total, all-cause mortality | Arm -2 Placebo | 0 | 102 |
| Total, other adverse events | Arm 1 -Etanercept | 10 | 99 |
| Total, other adverse events | Arm -2 Placebo | 12 | 102 |
| Total, serious adverse events | Arm 1 -Etanercept | 9 | 99 |
| Total, serious adverse events | Arm -2 Placebo | 10 | 102 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1 -Etanercept vs ARM 2 Placebo: Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro | Trial comparisons |
| Arm 1 -Etanercept vs ARM 2 Placebo: IVIG Refractory | Trial comparisons |
| Arm 1 -Etanercept vs Arm -2 Placebo: deaths from any cause | Trial comparisons |
| Arm 1 -Etanercept vs Arm -2 Placebo: 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/NCT00841789
GET https://conductscience.org/api/trials/v1/NCT00841789/registered