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 for Japanese Participants With Rheumatoid Arthritis (RA) (NCT01253226), a randomized phase 1 study. The primary outcome is Number of Participants With Adverse Events (AEs) [Clinically Significant Effects].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01253226 |
| Phase | Phase 1 |
| Condition | Rheumatoid Arthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Japanese participants with rheumatoid arthritis (RA) were the population of interest. The primary outcome population is described as randomized participants who received at least 1 dose of tabalumab or placebo. The record does not give further eligibility details or describe the participants’ baseline clinical characteristics.
Intervention
The study evaluated tabalumab, also called LY2127399, using several dose schedules. These included 30 mg, 60 mg, and 120 mg every 4 weeks (Q4W), as well as 120 mg every 2 weeks (Q2W) following an initial loading dose of 240 mg. Each tabalumab schedule was described as lasting 20 weeks.
Comparator
Placebo was included in Q4W and Q2W schedules. The registry record lists a single placebo group in its adverse-event results, without showing separate adverse-event counts for each placebo schedule. More detail about how placebo assignments were organized is not reported in the registry record.
Primary question
The primary outcome was the number of participants with clinically significant effects, defined as serious adverse events (SAEs) and other non-serious adverse events regardless of causality. The outcome timeframe extended from baseline through study completion, up to Week 32, with up to 12 weeks for B cell monitoring. The registry record does not report a formal statistical comparison of the tabalumab groups with placebo.
3. Trial Design
This was a randomized, double-blind, parallel-group Phase 1 study of tabalumab in Japanese participants with rheumatoid arthritis. The official title describes participants as being treated with methotrexate. The registry lists an enrollment of 32 and identifies Eli Lilly and Company as the sponsor. The study is marked completed; its recorded start was 2009-09 and its primary completion was 2011-08.
The study had a 20-week treatment period. Participants assigned to tabalumab could receive 30 mg, 60 mg, or 120 mg Q4W, or 120 mg Q2W after an initial loading dose of 240 mg. The Q4W schedules are described as six doses of study drug, while the Q2W schedule is described as ten doses. Placebo schedules are listed as Q4W and Q2W for 20 weeks. The registry record does not give the allocation ratio or explain the detailed randomization procedure.
Follow-up was described as continuing for up to 12 weeks after the last study-drug administration. The primary outcome timeframe is stated as baseline through study completion, up to Week 32, plus up to 12 weeks for B cell monitoring. The record does not explain how these timeframe descriptions relate to follow-up for individual outcomes.
Safety and tolerability were central aims. Listed secondary outcomes cover tabalumab pharmacokinetics, including area under the concentration-time curve and maximum observed drug concentration, and pharmacodynamic or laboratory measures. These include B cell counts, anti-CCP antibodies, rheumatoid factor, serum immunoglobulins, and CRP. The registry record does not report the number of participants assigned to each dose group as an overall enrollment breakdown; group-specific denominators are available for the adverse-event entries.
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: This dose-escalation study had 4 cohorts. Each cohort included 6 LY2127399 (tabalumab) participants and 2 placebo participants. Participants treated once every 2 weeks (Q2W) or once every 4 weeks (Q4W) and had a follow-up visit at Week 32. Additional visits beyond Week 32 were scheduled, as needed, for B cell count monitoring (up to 12 weeks).
Overall Study
| Stage | 30 mg Tabalumab Q4W | 60 mg Tabalumab Q4W | 120 mg Tabalumab Q4W | 120 mg Tabalumab Q2W | Placebo |
|---|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 | 8 |
| Received at Least 1 Dose of Study Drug | 6 | 6 | 6 | 6 | 8 |
| COMPLETED | 6 | 5 | 5 | 5 | 6 |
| NOT COMPLETED | 0 | 1 | 1 | 1 | 2 |
Reasons for not completing this period:
| Reason | 30 mg Tabalumab Q4W | 60 mg Tabalumab Q4W | 120 mg Tabalumab Q4W | 120 mg Tabalumab Q2W | Placebo |
|---|---|---|---|---|---|
| Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Death | 0 | 1 | 0 | 0 | 0 |
| Physician Decision | 0 | 0 | 0 | 0 | 2 |
| Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo).
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: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo).
| Characteristic | Unit | 30 mg Tabalumab Q4W | 60 mg Tabalumab Q4W | 120 mg Tabalumab Q4W | 120 mg Tabalumab Q2W | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 6 | 6 | 6 | 8 | 32 | |
| Age, Continuous | years | 66.0 (SD 5.9) | 50.0 (SD 15.0) | 55.5 (SD 14.2) | 56.7 (SD 8.0) | 58.4 (SD 17.1) | 57.4 (SD 13.3) |
| Sex: Female, Male: Female | Participants | 6 | 4 | 4 | 4 | 7 | 25 |
| Sex: Female, Male: Male | Participants | 0 | 2 | 2 | 2 | 1 | 7 |
| Race/Ethnicity, Customized: Japanese | Participants | 6 | 6 | 6 | 6 | 8 | 32 |
| Region of Enrollment: Japan | Participants | 6 | 6 | 6 | 6 | 8 | 32 |
| Current Use of Corticosteroids: Yes | Participants | 3 | 1 | 1 | 4 | 6 | 15 |
| Current Use of Corticosteroids: No | Participants | 3 | 5 | 5 | 2 | 2 | 17 |
| Body Weight | kilograms (kg) | 54.8 (SD 5.5) | 55.9 (SD 13.8) | 55.9 (SD 10.5) | 58.3 (SD 8.3) | 54.6 (SD 7.5) | 55.8 (SD 8.9) |
| C-Reactive Protein (CRP) | milligrams per deciliter (mg/dL) | 11.46 (SD 13.90) | 18.69 (SD 35.23) | 14.91 (SD 9.17) | 8.73 (SD 8.26) | 11.07 (SD 5.30) | 12.85 (SD 16.56) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs) [Clinically Significant Effects], measured over Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events classified as clinically significant effects. The registry definition includes serious adverse events and other non-serious adverse events, regardless of whether the event was considered related to study treatment. This broad safety endpoint is intended to capture events occurring during the study rather than to establish that a study drug caused them.
The stated population is randomized participants who received at least 1 dose of tabalumab or placebo. The timeframe runs from baseline through study completion, up to Week 32, with up to 12 weeks for B cell monitoring. The registry record does not explain the handling of participants who stopped treatment early or had incomplete follow-up.
For a count endpoint, the recorded number of participants with an event describes how many participants experienced an event within the specified category and observation period. It is distinct from the total number of event episodes, since one participant may experience more than one event. The registry record gives group counts for serious and other non-serious adverse events, but does not provide a single combined primary-endpoint result or a formal comparison across groups. The record also directs readers to its Reported Adverse Events module for summaries of serious and other non-serious events regardless of causality.
Counting events regardless of causality can be useful for monitoring safety because it does not depend on a judgment that treatment caused an event. At the same time, such counts alone cannot determine causation. Interpretation also depends on the groups’ observation periods, the definitions used, and the completeness of event reporting, details that are not fully described in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized, double-blind study with multiple tabalumab schedules and placebo, but it does not report a formal statistical analysis of the primary outcome. The record lists 0 analyses. It therefore supports a descriptive reading of the posted adverse-event counts, not an inferential conclusion about differences between treatment groups. No p-values, confidence intervals, adjusted estimates, or treatment-effect estimates are reported in the registry record.
For serious adverse events, the posted counts are 0 among 6 participants for 30 mg Tabalumab Q4W, 1 among 6 for 60 mg Tabalumab Q4W, 1 among 6 for 120 mg Tabalumab Q4W, 1 among 6 for 120 mg Tabalumab Q2W, and 1 among 8 for placebo. For other non-serious adverse events, the counts are 5 among 6, 4 among 6, 3 among 6, 6 among 6, and 5 among 8, respectively. These are separate event categories; the record does not state a combined count of participants with any clinically significant effect across the categories.
The counts are descriptive and do not establish that one schedule has a higher or lower underlying risk than another. In particular, the record does not provide uncertainty intervals or a statistical test for the group differences. With group-specific denominators as recorded, observed counts can be sensitive to the experience of individual participants, and they do not by themselves quantify uncertainty about event rates in a broader population.
The serious-event terms listed in the record are EYE MOVEMENT DISORDER, OCULAR HYPERTENSION, STRABISMUS, PNEUMONIA LEGIONELLA, CONJUNCTIVAL ABRASION, and CONTUSION. Each is paired with 16.7%. The record does not associate these terms with a particular treatment group in the information available for interpretation, and it does not provide the underlying term counts alongside those percentages. They should therefore be read as reported event-term summaries rather than as evidence for a group comparison.
Deaths are not reported in the registry record. The posted results do not give enough information to assess event timing, duration, severity beyond the serious/non-serious classification, or treatment attribution. The primary outcome also spans a stated follow-up period that includes B cell monitoring, while separate follow-up details for other outcomes are not reported. These limits make the record useful for describing what was recorded, but not for quantifying a comparative safety effect with precision.
9. Statistical Methods Explained
Statistical methods are the procedures used to summarize observations and assess how compatible the data are with a stated comparison or model. The registry record identifies the study as randomized, double-blind, and parallel-group, but it does not report a statistical analysis plan or analysis results. The explanations below describe general statistical concepts; they should not be read as methods confirmed to have been used in this trial.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable on average with respect to factors measured and not measured at baseline. It does not guarantee that groups will be identical, particularly in a study with small group-specific denominators. Randomization supports causal comparisons when the planned analysis, follow-up, and outcome measurement are also appropriate. The registry record does not provide details of the random sequence, allocation concealment, or allocation ratio, so those aspects cannot be assessed from the record.
What does double masking mean?
The registry identifies masking as double. In general, masking is intended to reduce the influence of knowledge about treatment assignment on participants’ experiences, clinical decisions, and outcome assessment. The record does not specify which roles were masked, how masking was maintained, or whether it was ever compromised. No assumptions about those procedures can be made from the masking label alone.
How should counts be understood?
The primary outcome is expressed as the number of participants with adverse events. A participant count is not the same as an event count: a participant can experience multiple events, while a participant-level endpoint generally records whether the participant met the endpoint definition. The registry gives separate counts for serious and other non-serious events. It does not report how those categories were combined for a single primary endpoint, whether participants appearing in both categories were counted once or more than once in any combined summary, or a formal estimate comparing study groups.
In general, comparisons of participant counts may be presented as absolute differences, relative measures, or model-based estimates, with uncertainty intervals. Such estimates depend on the analysis method and assumptions. None is reported for the primary outcome in the registry record, so none should be inferred from the posted counts. A confidence interval, in general, describes uncertainty around an estimate under a specified statistical procedure; it does not establish that the estimate is free from bias or that the treatment caused the observed events.
Why does follow-up matter?
Safety counts depend on the period during which events are observed and on whether participants are followed consistently. In general, unequal observation time can make simple counts difficult to compare, because a group observed longer may have more opportunity for events to be recorded. The record specifies treatment for 20 weeks and follow-up up to 12 weeks after the last study-drug administration. It does not report participant-level follow-up durations, event timing, or a time-to-event analysis. It is therefore not possible to assess from the record whether observation time was comparable across groups.
What can descriptive summaries establish?
Descriptive statistics organize observed data without, by themselves, testing a hypothesis or quantifying uncertainty. The adverse-event counts show the recorded number of participants in each listed group and category. They do not tell whether differences are larger than would be expected from random variation, nor do they show the likely range of a treatment effect in a target population. General inferential methods can address uncertainty, but their results depend on a specified estimand, model or test, assumptions, and analysis population. These details are not reported for the primary outcome.
What are the pharmacokinetic and pharmacodynamic outcomes?
Pharmacokinetic outcomes describe drug exposure, including the area under a concentration-time curve and maximum observed concentration. Pharmacodynamic outcomes describe biological responses associated with exposure. The registry lists B cell counts, anti-CCP antibody measures using two named methods, rheumatoid factor, serum immunoglobulins, and CRP. In general, these outcomes may be summarized as concentrations, counts, or changes from baseline, but the registry record does not provide their results, analysis methods, or estimates. No conclusion about their observed patterns can be drawn from their listing alone.
The record lists 10 outcome measures but 0 analyses. It does not report model specifications, covariate adjustments, missing-data procedures, subgroup analyses, or interim analyses. Those methods cannot be reconstructed from the outcome names or the adverse-event counts. Accordingly, the statistical interpretation should remain descriptive and bounded by what the registry record reports.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes: safety, pharmacokinetic measures, and pharmacodynamic or laboratory measures. It does not report a multiplicity strategy, such as a hierarchy of hypotheses, an adjustment for multiple comparisons, or a distinction between confirmatory and exploratory tests. Because the record lists 0 analyses, it also does not provide a set of reported inferential tests for which multiplicity handling can be evaluated. In general, testing many outcomes or group comparisons can increase the chance of at least one apparently unusual result by chance; whether that concern applies to a particular analysis depends on the analysis plan and testing structure, neither of which is reported.
Missing-data handling is not reported in the registry record. The record does not describe how missing outcome measurements, incomplete follow-up, treatment discontinuation, or participants without complete event reporting were handled. It also does not state whether analyses used all available observations, imputation, or another approach. No assumptions about missingness or the impact of missing data can therefore be assessed.
The primary outcome population is described as randomized participants who received at least 1 dose of study drug. This is a treatment-exposed population definition; the record does not state whether a separate analysis included all randomized participants regardless of treatment receipt. It does not provide participant flow, reasons for exclusions, or a breakdown of missing observations by group. Such information would help readers judge whether the analyzed population remained comparable through follow-up, but it is not reported in the registry record.
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 |
|---|---|---|---|
| 30 mg Tabalumab Q4W | 0 | 6 | 0.0% |
| 60 mg Tabalumab Q4W | 1 | 6 | 16.7% |
| 120 mg Tabalumab Q4W | 1 | 6 | 16.7% |
| 120 mg Tabalumab Q2W | 1 | 6 | 16.7% |
| Placebo | 1 | 8 | 12.5% |
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 |
|---|---|
| 30 mg Tabalumab Q4W | 5 of 6 |
| 60 mg Tabalumab Q4W | 4 of 6 |
| 120 mg Tabalumab Q4W | 3 of 6 |
| 120 mg Tabalumab Q2W | 6 of 6 |
| Placebo | 5 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | 30 mg Tabalumab Q4W | 60 mg Tabalumab Q4W | 120 mg Tabalumab Q4W | 120 mg Tabalumab Q2W | Placebo |
|---|---|---|---|---|---|---|
| EYE MOVEMENT DISORDER | Eye disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| OCULAR HYPERTENSION | Eye disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| STRABISMUS | Eye disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| PNEUMONIA LEGIONELLA | Infections and infestations | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 8 |
| PYELONEPHRITIS ACUTE | Infections and infestations | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 8 |
| CONJUNCTIVAL ABRASION | Injury, poisoning and procedural complications | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| CONTUSION | Injury, poisoning and procedural complications | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| LACERATION | Injury, poisoning and procedural complications | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 30 mg Tabalumab Q4W | 60 mg Tabalumab Q4W | 120 mg Tabalumab Q4W | 120 mg Tabalumab Q2W | Placebo |
|---|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | 2 of 6 | 2 of 6 | 0 of 6 | 2 of 6 | 2 of 8 |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | 1 of 6 | 0 of 6 | 1 of 6 | 3 of 6 | 0 of 8 |
| PYREXIA | General disorders | 1 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 1 of 8 |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 2 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 8 |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | 2 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 8 |
| STOMATITIS | Gastrointestinal disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 1 of 8 |
| PHARYNGITIS | Infections and infestations | 1 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 8 |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 1 of 8 |
| ANGINA PECTORIS | Cardiac disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
| PALPITATIONS | Cardiac disorders | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 8 |
Serious events with the highest arm-level rate: eye movement disorder (16.7%), ocular hypertension (16.7%), strabismus (16.7%), pneumonia legionella (16.7%), conjunctival abrasion (16.7%).
The serious adverse-event counts are 0 among 6 participants in the 30 mg Tabalumab Q4W group, 1 among 6 in the 60 mg Tabalumab Q4W group, 1 among 6 in the 120 mg Tabalumab Q4W group, 1 among 6 in the 120 mg Tabalumab Q2W group, and 1 among 8 in the placebo group. The other non-serious adverse-event counts are 5 among 6, 4 among 6, 3 among 6, 6 among 6, and 5 among 8 in those same listed groups.
These categories should be read separately. The registry defines the primary endpoint as including serious and other non-serious events regardless of causality, but the posted counts do not provide one combined participant-level result. A person could potentially be represented in both categories; the record does not explain how overlap was handled in a combined endpoint. The counts also do not indicate whether an event was caused by study treatment.
The serious-event terms listed are EYE MOVEMENT DISORDER, OCULAR HYPERTENSION, STRABISMUS, PNEUMONIA LEGIONELLA, CONJUNCTIVAL ABRASION, and CONTUSION, each shown with 16.7%. Their treatment-group attribution and underlying counts are not reported in the registry record. Deaths are also not reported in the registry record. These entries are descriptive safety information, not a comparative analysis.
12. What the Result Does, and Does Not, Mean
The record establishes that this Phase 1 study evaluated several tabalumab schedules and placebo in Japanese participants with rheumatoid arthritis, with safety and tolerability as central concerns. It records participant counts for serious and other non-serious adverse events in the listed groups. It also names pharmacokinetic and pharmacodynamic outcomes, but does not report their results in the registry record for interpretation.
The posted adverse-event counts do not establish a treatment effect. No statistical comparison, p-value, confidence interval, or adjusted estimate is reported for the primary outcome. The counts cannot determine whether apparent differences between groups reflect treatment, chance variation, differences in observation, or other factors. Nor do events reported regardless of causality show that the study drug caused those events.
General statistical interpretation distinguishes an observed result from the uncertainty around the underlying effect. Without an estimate and its uncertainty, the precision of a comparative effect cannot be evaluated. A count in a study group describes what was recorded in that group during the stated observation period; it is not by itself a prediction for other participants or settings.
The study’s randomized and double-blind designation describes aspects of its design, not the strength of a result. Evaluation of the conduct and analysis would also require details about allocation, participant flow, outcome ascertainment, follow-up, and missing data. Several of these details are not reported in the registry record. The record therefore supports a narrow descriptive account of the listed safety data and study design, while leaving comparative effectiveness and safety questions unresolved.
These findings should not be used to infer that any treatment schedule is beneficial or harmful. The registry record does not report a formal analysis capable of supporting that conclusion, and the listed outcome counts do not establish causality.
13. Why This Trial Matters Statistically
This study is statistically notable as a randomized, double-blind, parallel-group Phase 1 evaluation with several dose schedules and placebo. Its stated focus is safety and tolerability, alongside pharmacokinetic and pharmacodynamic measures. Such a design can generate descriptive information about events and biological measurements across dose schedules, but interpretation depends on complete reporting of the analysis and uncertainty.
The registry record makes an important distinction between the existence of outcome measures and the availability of analyzed results. It lists 10 outcome measures but 0 analyses. The presence of an endpoint name does not supply an estimate, uncertainty interval, or statistical test. For readers, this means the group-level adverse-event entries can be described, while comparative conclusions cannot be drawn from a reported inferential analysis.
The primary endpoint combines serious and other non-serious adverse events regardless of causality. That broad definition is relevant to safety monitoring, but a clear participant-level summary would be needed to understand how the categories were combined and how overlapping events were handled. The record gives separate category counts and does not report a combined estimate. This highlights why endpoint definitions and analysis populations matter as much as the raw counts.
More generally, the study illustrates the limits of interpreting descriptive counts without reported precision. Statistical uncertainty, follow-up completeness, missing-data handling, and the intended comparison all affect what a reader can conclude. Because those analysis details are not reported, the record is most informative as a description of the study’s design and posted event counts, rather than as evidence of a quantified comparative effect.
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 does not report a formal analysis of the primary outcome. It lists 0 analyses, with no p-values, confidence intervals, treatment-effect estimates, or model results. The separate adverse-event counts therefore cannot be interpreted as a tested comparison between tabalumab and placebo.
The primary endpoint is described as the number of participants with serious and other non-serious adverse events regardless of causality. However, the posted results give the two categories separately and do not report one combined participant-level count. The record does not explain possible overlap between participants in the two categories or how such overlap was handled. This limits direct interpretation of the primary endpoint as defined.
Group-specific denominators are reported for the adverse-event summaries, but the registry record does not provide participant flow or explain the relationship between the listed placebo schedule assignments and the single placebo category in the adverse-event entries. It also does not report event timing, duration, severity beyond the serious/non-serious classification, or exposure-adjusted summaries. Follow-up is described as continuing up to 12 weeks after the last study-drug administration, but actual follow-up by participant and group is not reported.
Missing-data procedures, analysis populations beyond the stated treatment-exposed primary population, multiplicity handling, and statistical methods are not reported. The listed serious-event terms have percentages but no corresponding underlying counts or group attribution in the record. Deaths are not reported in the registry record. These omissions prevent a more complete assessment of precision, comparative safety, and the potential influence of incomplete observation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study for Japanese Participants With Rheumatoid Arthritis (RA) — NCT01253226.
- Registry record last updated 2018-10-23; status last verified 2018-10.
- Results first posted 2018-10-23.
- 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
The registry describes a completed randomized, double-blind, parallel-group Phase 1 study of tabalumab in Japanese participants with rheumatoid arthritis. The official title specifies participants treated with methotrexate. The study included 30 mg, 60 mg, and 120 mg Q4W tabalumab schedules, a 120 mg Q2W schedule following a 240 mg loading dose, and placebo schedules. Treatment lasted 20 weeks, with follow-up described as up to 12 weeks after the last administration.
The primary outcome was participants with serious and other non-serious adverse events regardless of causality. The record posts separate event counts by group and lists pharmacokinetic and pharmacodynamic outcomes. It lists 10 outcome measures and 0 analyses. No formal comparative estimates, uncertainty intervals, or p-values are reported. The record does not report missing-data methods, multiplicity handling, or deaths.