Comparison · NCT00112385-fb1a8ccc
Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52. Trial comparisons, record NCT00112385-fb1a8ccc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00112385-fb1a8ccc
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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 | 0.0909 | 0.0162 | 0.377 | wilson | |
| Risk in group 2 | 0 | 0 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.35 | 0.377 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Etanercept than on Placebo | 11 | 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 | Etanercept | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks | 1 | 11 | OG000 |
| Group 2 | Placebo | Subjects will be given syringes containing placebo | 0 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
- Description
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52.
- Time frame
- At Screening, Week 12, 24, 40, and 52
- Population
Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
Source ClinicalTrials.gov
Trial
- Title
- A Pilot Study of Etanercept in Dermatomyositis
- NCT number
- NCT00112385
- Phases
- PHASE1
- Conditions
- Dermatomyositis
- Interventions
- Etanercept, Placebo
- Lead sponsor
- Brigham and Women's Hospital
- Results first posted
- 2011-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00112385?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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