Comparison · NCT05918978-7d979e4d
Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: Number of Participants With ADAs Against Efgartigimod
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. Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: Number of Participants With ADAs Against Efgartigimod. Trial comparisons, record NCT05918978-7d979e4d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05918978-7d979e4d
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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 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk in group 2 | 0.0769 | 0.0137 | 0.333 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0269 | -0.286 | 0.17 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.65 | 0.0445 | 9.5 | log | |
| Odds ratio, group 1 over group 2 | 0.632 | 0.036 | 11.1 | log | |
| Number needed to treat, for one fewer participant with the outcome on Efgartigimod-Efgartigimod than on Placebo-Efgartigimod | 37.1 | 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 | Efgartigimod-Efgartigimod | Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). | 1 | 20 | OG000 |
| Group 2 | Placebo-Efgartigimod | Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). | 1 | 13 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With ADAs Against Efgartigimod
- Description
Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.
- Time frame
- From the first dose of study drug (Day 1) up to Week 48
- Population
- The SAF included all enrolled participants exposed to study drug.
Source ClinicalTrials.gov
Trial
- Title
- Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
- NCT number
- NCT05918978
- Phases
- PHASE2
- Conditions
- Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
- Interventions
- Efgartigimod
- Lead sponsor
- argenx
- Results first posted
- 2025-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05918978?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.govNone 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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