Comparison · NCT00465985-78f080a4
ACZ885 vs Placebo: Number of Participants Who Experienced a Disease Flare in Part II
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. ACZ885 vs Placebo: Number of Participants Who Experienced a Disease Flare in Part II. Trial comparisons, record NCT00465985-78f080a4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00465985-78f080a4
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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 | 0 | 0.204 | wilson | |
| Risk in group 2 | 0.813 | 0.57 | 0.934 | wilson | |
| Risk difference, group 1 minus group 2 | -0.813 | -0.934 | -0.496 | 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 fewer participant with the outcome on ACZ885 than on Placebo | 1.23 | 1.07 | 2.02 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ACZ885 | ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks. | 0 | 15 | OG000 |
| Group 2 | Placebo | Placebo subcutaneous injection every 8 weeks. | 13 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced a Disease Flare in Part II
- Description
Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) \> 30 mg/L and either a PGA \> minimal, or PGA equal to minimal and \> minimal SD.
- Time frame
- 32 weeks after study start
- Population
Source ClinicalTrials.gov
Trial
- Title
- Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
- NCT number
- NCT00465985
- Phases
- PHASE3
- Conditions
- Muckle Wells Syndrome
- Interventions
- ACZ885, Placebo
- Lead sponsor
- Novartis
- Results first posted
- 2011-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00465985?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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