Comparison · NCT00841789-17cc61ba
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT00841789-17cc61ba. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00841789-17cc61ba
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.56 | 0.462 | 0.653 | wilson | |
| Risk in group 2 | 0.525 | 0.428 | 0.619 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0352 | -0.101 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.828 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.661 | 2.01 | log | |
| Number needed to treat, for one more participant with the outcome on Arm 1 -Etanercept than on ARM 2 Placebo | 28.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm 1 -Etanercept | Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin~Etanercept: etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis. | 56 | 100 | OG000 |
| Group 2 | ARM 2 Placebo | Placebo~Placebo: Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis. | 53 | 101 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- 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
- Description
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.
- Time frame
- 42 days after initial dose
- Population
- All patients receiving study drug with coronary measures improved
Source ClinicalTrials.gov
Trial
- Title
- A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
- NCT number
- NCT00841789
- Phases
- PHASE2
- Conditions
- Mucocutaneous Lymph Node Syndrome, Kawasaki Disease
- Interventions
- Etanercept, Placebo
- Lead sponsor
- Michael Portman
- Results first posted
- 2023-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00841789?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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