Comparison · NCT04999020-877e8f2d
RCP: Ravulizumab vs RCP: Placebo: Number of Participants With International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS-TIS) (TIS40) Response at Week 26 of the Randomized Controlled Period
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 International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS-TIS) (TIS40) Response at Week 26 of the Randomized Controlled Period. Trial comparisons, record NCT04999020-877e8f2d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04999020-877e8f2d
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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 | 0.346 | 0.194 | 0.538 | wilson | |
| Risk in group 2 | 0.5 | 0.254 | 0.746 | wilson | |
| Risk difference, group 1 minus group 2 | -0.154 | -0.443 | 0.158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.692 | 0.319 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.529 | 0.132 | 2.13 | log | |
| Number needed to treat, for one fewer participant with the outcome on RCP: Ravulizumab than on RCP: Placebo | 6.5 | 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. | 9 | 26 | OG000 |
| Group 2 | RCP: Placebo | Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP. | 6 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS-TIS) (TIS40) Response at Week 26 of the Randomized Controlled Period
- Description
Data are presented for the number of participants with a TIS40 response, defined as an IMACS-TIS score ≥ 40 at Week 26. IMACS-TIS is a clinical instrument that encompasses 6 core set measure (CSMs) (physician, patient, extra-muscular global activity, muscle strength, Health Assessment Questionnaire \[HAQ\], and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. A higher score indicated greater improvement. TIS40 was considered a moderate improvement score.
- 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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