Comparison · NCT04999020-5502e35a
RCP: Ravulizumab vs RCP: Placebo: Number of Participants With Response Related to Muscle Enzymes: Normalization of Most Abnormal Baseline Enzyme 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 Response Related to Muscle Enzymes: Normalization of Most Abnormal Baseline Enzyme at Week 26. Trial comparisons, record NCT04999020-5502e35a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04999020-5502e35a
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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 | 0.154 | 0.0615 | 0.335 | wilson | |
| Risk in group 2 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0705 | -0.215 | 0.264 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.85 | 0.23 | 14.8 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.199 | 20.1 | log | |
| Number needed to treat, for one more participant with the outcome on RCP: Ravulizumab than on RCP: Placebo | 14.2 | 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. | 4 | 26 | OG000 |
| Group 2 | RCP: Placebo | Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP. | 1 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Response Related to Muscle Enzymes: Normalization of Most Abnormal Baseline Enzyme at Week 26
- Description
Laboratory tests were conducted to measure serum activities of muscle associated enzymes including creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and aldolase. Data are presented for the number of participants who had an abnormal muscle enzyme at baseline that had been normalized at Week 26.
- Time frame
- Baseline, 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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