Comparison · NCT04524273-e517812a
Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and 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 With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population. Trial comparisons, record NCT04524273-e517812a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04524273-e517812a
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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 | 0.687 | 0.597 | 0.765 | wilson | |
| Risk in group 2 | 0.482 | 0.393 | 0.573 | wilson | |
| Risk difference, group 1 minus group 2 | 0.205 | 0.0769 | 0.323 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 1.14 | 1.79 | log | |
| Odds ratio, group 1 over group 2 | 2.35 | 1.37 | 4.03 | log | |
| Number needed to treat, for one more participant with the outcome on Overall: Inebilizumab 300 mg than on Overall: Placebo | 4.89 | 3.1 | 13 | 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). | 79 | 115 | 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). | 55 | 114 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population
- Description
MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.~The protocol-allowed rescue therapy options included intravenous immunoglobulin (IVIg) and therapeutic plasma exchange (PLEX).~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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