Comparison · NCT06028438-sae
Group 1: Certolizumab and Placebo vs Group 2: Certolizumab and Nipocalimab: 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 1: Certolizumab and Placebo vs Group 2: Certolizumab and Nipocalimab: serious adverse events. Trial comparisons, record NCT06028438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06028438-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 | 0.0244 | 0.00432 | 0.126 | wilson | |
| Risk in group 2 | 0.113 | 0.0558 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0885 | -0.193 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.216 | 0.0276 | 1.69 | log | |
| Odds ratio, group 1 over group 2 | 0.196 | 0.0232 | 1.66 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group 1: Certolizumab and Placebo than on Group 2: Certolizumab and Nipocalimab | 11.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group 1: Certolizumab and Placebo | Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22. | 1 | 41 | EG000 |
| Group 2 | Group 2: Certolizumab and Nipocalimab | Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22. | 7 | 62 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
- NCT number
- NCT06028438
- Phases
- PHASE2
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Placebo, Nipocalimab, Certolizumab
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2025-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06028438?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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