Comparison · NCT03600818-fb7e2878
Placebo+52 Week Taper vs Sarilumab 200mg q2w+14 Week Taper: Number of Participants With Absence of Disease Flare From Week 12 Through Week 52
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. Placebo+52 Week Taper vs Sarilumab 200mg q2w+14 Week Taper: Number of Participants With Absence of Disease Flare From Week 12 Through Week 52. Trial comparisons, record NCT03600818-fb7e2878. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03600818-fb7e2878
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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 | 0.328 | 0.221 | 0.456 | wilson | |
| Risk in group 2 | 0.55 | 0.425 | 0.669 | wilson | |
| Risk difference, group 1 minus group 2 | -0.222 | -0.382 | -0.0433 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.596 | 0.386 | 0.919 | log | |
| Odds ratio, group 1 over group 2 | 0.399 | 0.189 | 0.842 | log | |
| Number needed to treat, for one fewer participant with the outcome on Placebo+52 Week Taper than on Sarilumab 200mg q2w+14 Week Taper | 4.5 | 2.62 | 23.1 | from the risk difference interval |
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 | Placebo+52 Week Taper | Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. | 19 | 58 | OG000 |
| Group 2 | Sarilumab 200mg q2w+14 Week Taper | Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52. | 33 | 60 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Absence of Disease Flare From Week 12 Through Week 52
- Description
Disease flare was defined as either recurrence of signs and symptoms attributable to active PMR plus an increase in CS dose due to PMR, or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR.
- Time frame
- From Week 12 Through Week 52
- Population
- Analysis was performed on ITT population.
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
- NCT number
- NCT03600818
- Phases
- PHASE3
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Sarilumab SAR153191 (REGN88), Sarilumab-matching placebo, Prednisone, Prednisone-matching placebo, Prednisone
- Lead sponsor
- Sanofi
- Results first posted
- 2022-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03600818?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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