Comparison · NCT01146652-sae
Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) vs Sarilumab Monotherapy: 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. Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) vs Sarilumab Monotherapy: serious adverse events. Trial comparisons, record NCT01146652-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01146652-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 | 0.323 | 0.302 | 0.344 | wilson | |
| Risk in group 2 | 0.243 | 0.173 | 0.331 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0798 | -0.0101 | 0.153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.95 | 1.86 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.952 | 2.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) than on Sarilumab Monotherapy | 12.5 | 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 | Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase \[ALT\]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking. | 617 | 1,910 | EG000 |
| Group 2 | Sarilumab Monotherapy | Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). | 27 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose (i.e., Day 1 of study LTS11210) of IMP to last dose of IMP + 60 days (maximum duration: up to 523 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
- NCT number
- NCT01146652
- Phases
- PHASE3
- Conditions
- Rheumatoid Arthritis
- Interventions
- SAR153191 (REGN88)
- Lead sponsor
- Sanofi
- Results first posted
- 2022-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01146652?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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