Comparison · NCT04991753-sae
Group 2: Nipocalimab vs Group 1: Placebo: serious adverse events
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. Group 2: Nipocalimab vs Group 1: Placebo: serious adverse events. Trial comparisons, record NCT04991753-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04991753-sae
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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 | 0.0909 | 0.0314 | 0.236 | wilson | |
| Risk in group 2 | 0 | 0 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.0809 | 0.236 | 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 harm, for one more participant with a serious adverse event on Group 2: Nipocalimab than on Group 1: Placebo | 11 | 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 | Group 2: Nipocalimab | Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. | 3 | 33 | EG001 |
| Group 2 | Group 1: Placebo | Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. | 0 | 20 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
Source ClinicalTrials.gov
Trial
- Title
- A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
- NCT number
- NCT04991753
- Phases
- PHASE2
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Placebo, Nipocalimab
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2025-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04991753?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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