Comparison · NCT04524273-1e5931ec
Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population
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. Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population. Trial comparisons, record NCT04524273-1e5931ec. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04524273-1e5931ec
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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 | 0.16 | 0.105 | 0.236 | wilson | |
| Risk in group 2 | 0.35 | 0.27 | 0.44 | wilson | |
| Risk difference, group 1 minus group 2 | -0.191 | -0.296 | -0.0799 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.456 | 0.282 | 0.737 | log | |
| Odds ratio, group 1 over group 2 | 0.352 | 0.189 | 0.655 | log | |
| Number needed to treat, for one fewer participant with the outcome on Overall: Inebilizumab 300 mg than on Overall: Placebo | 5.24 | 3.38 | 12.5 | 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 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). | 19 | 119 | OG001 |
| Group 2 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | 41 | 117 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population
- Description
An exacerbation was defined as one of the following:~* Use of protocol defined rescue therapy, or~* Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or~* Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.~Outcome measure is reported for the overall population.
- Time frame
- Up to Week 26
- Population
- FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations.
Source ClinicalTrials.gov
Trial
- Title
- Myasthenia Gravis Inebilizumab Trial
- NCT number
- NCT04524273
- Phases
- PHASE3
- Conditions
- Myasthenia Gravis
- Interventions
- inebilizumab, IV Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2026-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04524273?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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