This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) (NCT02373202), a randomized phase 3 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02373202 |
| Phase | Phase 3 |
| Condition | Rheumatoid Arthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 91 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
Japanese patients with active rheumatoid arthritis, as described in the study title. The registry record reports 91 participants enrolled. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Sarilumab given by subcutaneous injection every two weeks at 150 mg or 200 mg, either alone or alongside non-methotrexate disease-modifying antirheumatic drugs. The permitted background drugs were sulfasalazine, leflunomide, bucillamine, tacrolimus, and mizoribine. Treatment was described as lasting up to 52 weeks.
Comparator
The registry lists four parallel treatment groups: the two sarilumab doses with non-methotrexate DMARDs and the same two doses as monotherapy. It does not list a placebo or a group receiving no sarilumab. The record does not state a single prespecified pairwise comparison as the primary question.
Primary question
The primary objective was to document long-term safety. The primary endpoint counted participants with treatment-emergent adverse events and serious adverse events from baseline up to Week 58. Long-term efficacy was a secondary objective, with ACR responses, change in DAS28-CRP, and change in HAQ-DI among the listed outcomes.
The clinical question is therefore principally about safety across four sarilumab regimens in this population, rather than about a single comparison against an untreated or placebo group. The registry identifies both monotherapy and treatment alongside non-methotrexate DMARDs, but does not state that the four groups were intended to be combined or directly contrasted in a particular way. It also does not report numerical results for the listed efficacy outcomes. Consequently, the clinical question can be described from the objectives and treatment assignments, while conclusions about comparative efficacy cannot be drawn from the registry record.
3. Trial Design
This was a randomized, phase 3, multicenter, parallel-group study with quadruple masking. The registry reports 91 participants enrolled and marks the study as completed. Its start is listed as 2015-02 and its primary completion as 2016-11. The record labels the study quadruple-masked but does not identify which participant, clinician, assessor, or other roles were masked, nor does it provide details of the randomization procedure or allocation concealment.
The four groups received sarilumab 150 mg or 200 mg by subcutaneous injection every two weeks, either with non-methotrexate DMARDs or as monotherapy. In the combination groups, background treatment could include sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine. The described treatment period was up to 52 weeks. The registry does not report a common background-therapy regimen, the distribution of background drugs, or a treatment adherence summary.
The study’s primary objective was to document long-term safety, and its secondary objective was to document long-term efficacy. The primary safety observation window is stated as baseline up to Week 58. Secondary outcomes include ACR 20, 50, and 70 responses at Week 52, change from baseline in DAS28-CRP at Week 52, and change from baseline in HAQ-DI at Week 52. The registry lists 11 outcome measures but does not provide numerical results for these efficacy measures in the record described.
Although randomization and parallel groups support planned comparisons between assigned regimens, the registry record does not specify which comparisons were intended for confirmatory inference, how treatment groups were to be analyzed, or how the background DMARD choices were handled statistically. Details of eligibility, the planned allocation ratio, and the protocol’s sample-size justification are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks \[q2w\] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs \[Non-MTX DMARDs\] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).
Overall Study
| Stage | Sarilumab 150 mg q2w + DMARDs | Sarilumab 200 mg q2w + DMARDs | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w |
|---|---|---|---|---|
| STARTED | 15 | 15 | 30 | 31 |
| COMPLETED | 13 | 9 | 27 | 30 |
| NOT COMPLETED | 2 | 6 | 3 | 1 |
Reasons for not completing this period:
| Reason | Sarilumab 150 mg q2w + DMARDs | Sarilumab 200 mg q2w + DMARDs | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w |
|---|---|---|---|---|
| Adverse Event | 2 | 5 | 2 | 1 |
| Lack of Efficacy | 0 | 0 | 1 | 0 |
| Other | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of investigational medicinal product (IMP), irrespective of compliance with the study protocol and procedures.
| Characteristic | Unit | Sarilumab 150 mg q2w + DMARDs | Sarilumab 200 mg q2w + DMARDs | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 15 | 15 | 30 | 31 | 91 | |
| Age, Continuous | years | 56.3 (SD 10.9) | 63.3 (SD 10.6) | 54.4 (SD 13.8) | 52.5 (SD 10.3) | 55.6 (SD 12.1) |
| Sex: Female, Male: Female | Participants | 12 | 13 | 27 | 26 | 78 |
| Sex: Female, Male: Male | Participants | 3 | 2 | 3 | 5 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), measured over Baseline up to Week 58.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-emergent adverse events and serious adverse events. An adverse event was defined as an untoward medical occurrence after a participant received the investigational medicinal product; it did not have to be causally related to treatment. Events from the first dose through six weeks after the last dose were considered treatment-emergent, with the stated observation period extending up to Week 58. Treatment-emergent adverse events included both serious and non-serious events.
A serious adverse event was defined by outcomes such as death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, congenital anomaly, or another medically important event. This definition captures seriousness based on consequences or medical importance, rather than requiring a judgment that treatment caused the event.
Counting participants with events is a way to describe how many people experienced an event during the specified period. It is useful for safety monitoring because it includes events regardless of whether a causal relationship was established. The count does not, by itself, describe event duration, recurrence, severity beyond the serious/non-serious distinction, or the time each participant was at risk. The registry record does not report a statistical comparison or a causal assessment for the event counts.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports safety counts across four sarilumab regimens. For serious adverse events, the reported participant counts are 0 of 15 in the 150 mg combination group, 3 of 15 in the 200 mg combination group, 1 of 30 in the 150 mg monotherapy group, and 2 of 31 in the 200 mg monotherapy group. The record also reports other adverse-event participant counts of 14 of 15, 13 of 15, 22 of 30, and 23 of 31, respectively. These are descriptive group-level figures; the registry record does not report inferential comparisons for them.
The record lists several serious adverse-event terms with percentages: chronic sinusitis, periorbital abscess, breast cancer female, and gastric cancer are each listed at 6.7%; herpes zoster oticus is listed at 3.3%; and pneumonia bacterial is listed at 3.2%. These terms should be read as entries in the registry’s serious-event listing, not as evidence about the cause of an event or a comparison between regimens. The registry also records zero deaths in each treatment group.
The primary objective was safety, but the title of the endpoint and the posted group counts do not establish that the regimens are equivalent or that any difference between groups is statistically reliable. The group sizes differ, and the event counts are small. Without estimates of uncertainty or a reported analysis, the counts alone do not quantify how compatible the results are with a range of underlying event rates. General statistical interpretation: a confidence interval expresses uncertainty around an estimate; no confidence intervals for these event counts are reported in the registry record.
The study also listed efficacy outcomes, including ACR responses at Week 52 and changes in DAS28-CRP and HAQ-DI. Numerical efficacy results, treatment-effect estimates, confidence intervals, and p-values are not reported in the registry record. Therefore, the safety counts cannot answer whether the regimens differed in efficacy, and the planned efficacy measures cannot be interpreted from their names alone. The registry’s stated objectives describe what the study sought to document, not the magnitude or certainty of any observed efficacy effect.
In short, the posted safety data describe the number of participants with serious and other adverse events in each group during the stated period. They do not supply the comparative statistical analysis needed to determine whether between-group differences exceed what could plausibly arise from sampling variability. Nor do they establish causation for individual events. The available record supports a descriptive reading, with substantial limits on comparative conclusions.
9. Statistical Methods Explained
The registry identifies the study as randomized, parallel-group, and quadruple-masked. Those design labels describe how the trial was organized, not the statistical methods used to analyze its outcomes. The analysis model, handling of repeated measurements, adjustment variables, and planned hypothesis tests are not reported in the registry record. The sections below explain general statistical concepts relevant to interpreting the listed outcomes; they do not imply that a particular method was used in this study.
What does randomization contribute?
General explanation: random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics at the point of assignment. It can support causal comparisons when the assignment process is maintained and outcomes are analyzed as planned. Randomization does not guarantee that small groups will have identical baseline characteristics. The registry does not provide the randomization sequence method, allocation concealment details, or baseline balance information, so those aspects cannot be assessed from this record.
The four assigned regimens differ in both sarilumab dose and whether non-methotrexate DMARDs were used. The combination arms also allowed several background drugs. A contrast between groups could therefore address a specific regimen comparison only if the comparison were defined and analyzed appropriately. The registry record does not identify the primary pairwise contrasts or explain whether background-drug choices were accounted for in the analysis.
How should binary safety counts be understood?
The primary safety outcome is expressed as participants who experienced events, so it is a binary participant-level outcome: each participant either had at least one event in the relevant category during the observation window or did not. General explanation: a count and its denominator give a direct description of observed frequency within a group. A count does not show whether one participant experienced multiple events, and it does not distinguish a single episode from recurrent episodes unless those are separately reported.
General explanation: when comparing binary outcomes, statistical methods can estimate differences or relative measures between groups and quantify uncertainty around those estimates. The choice of measure and method depends on the design, event frequency, and analysis plan. The registry record does not report such comparative estimates, confidence intervals, or p-values for the primary safety endpoint. No inferential method should be attributed to the study on the basis of the counts alone.
The event observation period begins with the first dose and extends to six weeks after the last dose, up to Week 58. General explanation: participants may contribute different amounts of time under observation if treatment or follow-up ends at different times. A simple participant count does not adjust for differences in time at risk. The record does not report person-time analyses or a time-to-event analysis for these outcomes.
What is the role of efficacy measures?
The listed secondary efficacy outcomes include ACR 20, 50, and 70 response percentages at Week 52, and changes from baseline in DAS28-CRP and HAQ-DI. General explanation: response outcomes classify whether a participant meets a specified response criterion, while change outcomes compare a follow-up measurement with a baseline measurement. ACR response categories, disease activity scores, and disability-index changes capture different aspects of outcome and should not be treated as interchangeable. The registry record names these measures but does not provide their numerical results, analysis populations, or treatment-effect estimates.
For continuous change outcomes, general statistical analysis can account for baseline values and repeated measurements, but the choice of approach matters for interpretation. The record does not report whether an analysis used baseline adjustment, a repeated-measures model, imputation, or another method. For response outcomes, the record does not specify the denominator used at Week 52 or how missing assessments were handled. These details are important because the result can depend on the analysis population and rules for incomplete observations.
What do significance levels and planning illustrations mean?
General explanation: a significance level is a prespecified threshold used to guide a hypothesis test under a statistical plan. The planning convention recorded for sample-size illustrations uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect framed as a stated fraction of an observed effect. These are planning assumptions for illustrations, not evidence of the trial’s original design or a report of observed power. The protocol’s own sample-size justification is not reported in the registry record.
A planning calculation asks how many participants might be needed under specified assumptions. It does not show the probability that this completed study detected an effect, and it does not replace a treatment-effect estimate with uncertainty. General explanation: observed power, when calculated from an observed effect, largely restates the result and is not a substitute for confidence intervals. No sample-size justification or prespecified power target for the trial is reported in the registry record.
The registry lists zero analysis entries. It does not report an analysis plan, multiplicity procedure, interim-analysis plan, missing-data method, or model for the efficacy outcomes. These omissions do not establish that the protocol had no such procedures; they mean those details cannot be determined from the registry record. Any interpretation should therefore distinguish the documented study design and event counts from statistical procedures that are not described.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes: ACR 20, 50, and 70 responses at Week 52, change from baseline in DAS28-CRP at Week 52, and change from baseline in HAQ-DI at Week 52. It also lists 11 outcome measures overall. When several outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if no adjustment or hierarchy is used. General explanation: multiplicity procedures can control this risk or define which findings are confirmatory. A multiplicity strategy is not reported in the registry record.
The record does not describe whether interim analyses were planned or conducted, whether efficacy outcomes were tested under a hierarchical sequence, or whether any adjustment was made for multiple doses, treatment settings, or response thresholds. It also contains zero analysis entries. These absences mean that the statistical status of any efficacy finding cannot be determined from the registry record; they do not prove that no analysis was performed outside the record.
Missing-data handling is also not reported. The record does not state how participants who discontinued, missed a Week 52 assessment, or had incomplete follow-up were treated in efficacy analyses. It does not report imputation methods, sensitivity analyses, or the analysis population for those secondary outcomes. These choices can affect both the estimated response and its uncertainty, especially when outcomes are measured at a specified follow-up visit.
For safety, the registry defines a safety population as randomized participants who received at least one dose or partial dose, analyzed according to treatment actually received. The listed group counts therefore concern a treated safety population as described in the record. The efficacy analysis population and its handling of participants who changed or stopped treatment are not reported in the registry record. The safety definition should not be assumed to apply to every secondary outcome.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sarilumab 150 mg q2w + DMARDs | 0 | 15 | 0.0% |
| Sarilumab 200 mg q2w + DMARDs | 3 | 15 | 20.0% |
| Sarilumab 150 mg q2w Monotherapy | 1 | 30 | 3.3% |
| Sarilumab 200 mg q2w Monotherapy | 2 | 31 | 6.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sarilumab 150 mg q2w + DMARDs | 0 of 15 |
| Sarilumab 200 mg q2w + DMARDs | 0 of 15 |
| Sarilumab 150 mg q2w Monotherapy | 0 of 30 |
| Sarilumab 200 mg q2w Monotherapy | 0 of 31 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sarilumab 150 mg q2w + DMARDs | 14 of 15 |
| Sarilumab 200 mg q2w + DMARDs | 13 of 15 |
| Sarilumab 150 mg q2w Monotherapy | 22 of 30 |
| Sarilumab 200 mg q2w Monotherapy | 23 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Sarilumab 150 mg q2w + DMARDs | Sarilumab 200 mg q2w + DMARDs | Sarilumab 150 mg q2w Monotherapy | Sarilumab 200 mg q2w Monotherapy |
|---|---|---|---|---|---|
| Chronic sinusitis | Infections and infestations | 0 of 15 | 1 of 15 | 0 of 30 | 0 of 31 |
| Herpes zoster oticus | Infections and infestations | 0 of 15 | 0 of 15 | 1 of 30 | 0 of 31 |
| Periorbital abscess | Infections and infestations | 0 of 15 | 1 of 15 | 0 of 30 | 0 of 31 |
| Pneumonia bacterial | Infections and infestations | 0 of 15 | 0 of 15 | 0 of 30 | 1 of 31 |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 15 | 1 of 15 | 0 of 30 | 0 of 31 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 15 | 1 of 15 | 0 of 30 | 0 of 31 |
| Abortion induced | Surgical and medical procedures | 0 of 15 | 0 of 15 | 0 of 30 | 1 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sarilumab 150 mg q2w + DMARDs | Sarilumab 200 mg q2w + DMARDs | Sarilumab 150 mg q2w Monotherapy | Sarilumab 200 mg q2w Monotherapy |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 4 of 15 | 5 of 15 | 13 of 30 | 14 of 31 |
| Stomatitis | Gastrointestinal disorders | 3 of 15 | 4 of 15 | 3 of 30 | 4 of 31 |
| Neutropenia | Blood and lymphatic system disorders | 5 of 15 | 3 of 15 | 1 of 30 | 3 of 31 |
| Injection site erythema | General disorders | 0 of 15 | 1 of 15 | 1 of 30 | 6 of 31 |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | 1 of 15 | 0 of 15 | 4 of 30 | 2 of 31 |
| Hepatic function abnormal | Hepatobiliary disorders | 1 of 15 | 0 of 15 | 1 of 30 | 4 of 31 |
| Contusion | Injury, poisoning and procedural complications | 3 of 15 | 0 of 15 | 2 of 30 | 0 of 31 |
| Neutrophil count decreased | Investigations | 1 of 15 | 1 of 15 | 2 of 30 | 1 of 31 |
| Dizziness | Nervous system disorders | 0 of 15 | 2 of 15 | 2 of 30 | 1 of 31 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 0 of 15 | 3 of 30 | 2 of 31 |
Serious events with the highest arm-level rate: chronic sinusitis (6.7%), periorbital abscess (6.7%), breast cancer female (6.7%), gastric cancer (6.7%), herpes zoster oticus (3.3%).
The serious adverse-event counts are 0 of 15 for sarilumab 150 mg every two weeks with non-methotrexate DMARDs, 3 of 15 for sarilumab 200 mg with non-methotrexate DMARDs, 1 of 30 for sarilumab 150 mg monotherapy, and 2 of 31 for sarilumab 200 mg monotherapy. The registry reports zero deaths in all four groups. It also lists other adverse-event participant counts of 14 of 15, 13 of 15, 22 of 30, and 23 of 31, in the same group order.
These are observed counts during the safety observation period, not adjusted comparisons. The serious-event terms and percentages are chronic sinusitis at 6.7%, periorbital abscess at 6.7%, breast cancer female at 6.7%, gastric cancer at 6.7%, herpes zoster oticus at 3.3%, and pneumonia bacterial at 3.2%. The registry does not establish that treatment caused these events, and the listing does not provide a comparative estimate or uncertainty interval. A zero count in a group means no event was recorded there in the posted data; it does not establish that the underlying risk is zero.
12. What the Result Does, and Does Not, Mean
The record supports a limited descriptive conclusion: it documents participant counts for serious and other adverse events across four sarilumab regimens during the specified safety period. It also states that the primary purpose was to document long-term safety. The counts are relevant to that objective, but they are not accompanied by comparative estimates, confidence intervals, or p-values in the registry record. They therefore do not establish whether differences between groups are statistically distinguishable or how precisely an underlying event frequency is estimated.
The study’s efficacy objectives and outcomes are also clear at the level of what was planned. The listed measures concern ACR responses, DAS28-CRP change, and HAQ-DI change, including assessments at Week 52. However, their numerical results are not reported in the registry record. The existence of an efficacy outcome in the record is not itself evidence of an observed benefit, and no conclusion about the magnitude of efficacy can be made from the outcome names alone.
General explanation: a randomized study can be designed to estimate differences between assigned regimens, but inference depends on the actual outcome data, analysis population, analysis method, and uncertainty estimates. Here, the registry provides the design labels and safety counts but not the statistical analysis details needed for a fuller comparison. It also does not report a protocol sample-size justification, a multiplicity plan, or missing-data methods.
The findings should not be generalized automatically beyond the study population and treatment settings described. The population was Japanese patients with active rheumatoid arthritis, and combination treatment could involve different non-methotrexate DMARDs. The registry does not provide enough information to assess how participant characteristics or background treatments varied. Accordingly, the record is informative as a description of the trial’s intended safety and efficacy questions and its posted safety counts, but it does not support a definitive comparative efficacy or safety claim.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that matter when reading randomized safety studies. First, its primary endpoint is a participant count over a defined treatment-emergent period. That measure is straightforward to describe, but it does not capture recurrence, duration, or time to first event. A person with one event and a person with repeated events may each contribute as a participant with an event unless event-level analyses are reported separately.
Second, the design includes four regimens that vary by sarilumab dose and by use of non-methotrexate DMARDs. The combination regimens also permit several background drugs. This makes the definition of the intended treatment comparison important: a comparison of doses within monotherapy is not the same question as a comparison of combination therapy with monotherapy. The registry record does not state which contrasts were confirmatory or how background therapy was handled analytically.
Third, sparse serious-event counts require careful interpretation. Counts in groups of the reported sizes are descriptive, and without estimates of uncertainty they do not show how much the observed differences might vary across samples. General explanation: confidence intervals can help communicate this uncertainty, while a p-value alone would not show the size or precision of a difference. Neither confidence intervals nor comparative tests are reported in the registry record.
Finally, the record lists several efficacy outcomes but does not include their numerical results or explain multiplicity and missing-data procedures. Those details are important when a study has multiple outcomes and assessments. The trial therefore illustrates why design labels and posted event counts should be distinguished from a complete statistical analysis: the former describe what was done or recorded, while the latter is needed to assess comparative effects and their uncertainty.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record provides a limited basis for evaluating the trial beyond its design and posted safety counts. It does not report eligibility criteria in detail, baseline characteristics, the randomization procedure, the allocation ratio, or which roles were masked. The label quadruple masking is present, but the identities of the masked groups are not specified. These omissions restrict assessment of how the trial was implemented and how comparable the groups were at baseline.
The primary endpoint is described as a number of participants with treatment-emergent and serious adverse events, but no statistical comparison, confidence interval, or p-value is reported. The record does not supply event-level detail sufficient to assess recurrence, duration, or time at risk. The serious-event listing gives selected terms and percentages, but it does not state in that listing how the percentages were calculated. The zero death counts should be understood as recorded observations, not as evidence that death risk was absent.
The efficacy outcomes are named, but their numerical results and analysis details are not reported in the registry record. Missing-data rules, analysis populations for efficacy, multiplicity procedures, interim analyses, and the protocol’s sample-size justification are also not reported. The record therefore does not support a detailed assessment of efficacy or the statistical certainty of between-group comparisons.
Applicability is constrained by the stated population and treatment choices: Japanese patients with active rheumatoid arthritis, receiving sarilumab alone or with permitted non-methotrexate DMARDs. The registry does not provide enough detail to judge how the participants or background treatment patterns compare with other settings. Follow-up for treatment-emergent events is described up to Week 58; longer-term outcomes beyond that period are not characterized by the posted endpoint description.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) — NCT02373202.
- Registry record last updated 2018-01-30; status last verified 2018-01.
- Results first posted 2018-01-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02373202 is a completed phase 3 randomized, parallel-group, quadruple-masked, multicenter study of sarilumab in Japanese patients with active rheumatoid arthritis. The registry reports 91 participants enrolled and four regimens: sarilumab 150 mg or 200 mg every two weeks as monotherapy or with non-methotrexate DMARDs. Treatment was described as lasting up to 52 weeks.
The primary objective was long-term safety. The primary endpoint counted participants with treatment-emergent adverse events and serious adverse events from baseline up to Week 58. The registry posts group-level safety counts and selected serious-event terms. Secondary outcomes included ACR responses and changes in DAS28-CRP and HAQ-DI at Week 52, but numerical efficacy results are not reported in the registry record.
Statistical analysis details, missing-data procedures, multiplicity methods, and a protocol sample-size justification are not reported in the registry record. The posted information therefore supports a descriptive account of the design and safety counts, but not a complete comparative assessment of efficacy or safety.