Comparison · NCT04201262-ccf76b35
Ravulizumab vs Placebo (ECU-NMO-301): Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
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. Ravulizumab vs Placebo (ECU-NMO-301): Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period. Trial comparisons, record NCT04201262-ccf76b35. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04201262-ccf76b35
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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 | 0.0621 | wilson | |
| Risk in group 2 | 0.426 | 0.295 | 0.567 | wilson | |
| Risk difference, group 1 minus group 2 | -0.426 | -0.567 | -0.281 | 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 Ravulizumab than on Placebo (ECU-NMO-301) | 2.35 | 1.76 | 3.56 | 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 | Ravulizumab | Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years. | 0 | 58 | OG000 |
| Group 2 | Placebo (ECU-NMO-301) | Participants who received eculizumab matching placebo in study ECU-NMO-301. | 20 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
- Description
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.
- Time frame
- Baseline up to 2.25 years (end of the Primary Treatment Period)
- Population
- The full analysis set (FAS) included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
- NCT number
- NCT04201262
- Phases
- PHASE3
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
- Interventions
- Ravulizumab
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2023-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04201262?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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