Comparison · NCT04999020-fb8e5c3e
RCP: Ravulizumab vs RCP: Placebo: Number of Participants With Cutaneous Dermatomyositis Activity Physician's Global Assessment (CDA-IGA) Response at Week 26
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. RCP: Ravulizumab vs RCP: Placebo: Number of Participants With Cutaneous Dermatomyositis Activity Physician's Global Assessment (CDA-IGA) Response at Week 26. Trial comparisons, record NCT04999020-fb8e5c3e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04999020-fb8e5c3e
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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 | 0.192 | 0.0851 | 0.379 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0256 | -0.275 | 0.247 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.26 | 5.12 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.196 | 7.23 | log | |
| Number needed to treat, for one more participant with the outcome on RCP: Ravulizumab than on RCP: Placebo | 39 | 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 | RCP: Ravulizumab | Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP. | 5 | 26 | OG000 |
| Group 2 | RCP: Placebo | Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP. | 2 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Cutaneous Dermatomyositis Activity Physician's Global Assessment (CDA-IGA) Response at Week 26
- Description
CDA-IGA is a scale that was created to measure disease severity in participants with skin disease. It is a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) with morphologic descriptors for each score. The CDA-IGA was completed by the Investigator and was used to describe the overall appearance of lesions at a given time point. Data are presented for the number of participants with a CDA-IGA response at Week 26. A response was defined as participants with clear or almost clear skin (score of 0 or 1) who did not have an intercurrent event at or before the relevant timepoint.
- Time frame
- Week 26
- Population
- Randomized Set, which included all randomized participants grouped by randomized treatment group.
Source ClinicalTrials.gov
Trial
- Title
- Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
- NCT number
- NCT04999020
- Phases
- PHASE2, PHASE3
- Conditions
- Dermatomyositis
- Interventions
- Ravulizumab, Placebo
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2024-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04999020?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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