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 Low-dose IL-2( Interleukin-2) Treatment in SLE (NCT02084238), a na na study. The primary outcome is Number of Participants Who Were SLE Responders (SRI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02084238 |
| Phase | NA |
| Condition | Systemic Lupus Erythematosus |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Peking University People's Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with systemic lupus erythematosus (SLE). The registry describes the treatment as intended for activated SLE, but does not report further eligibility details or describe the characteristics of the participants who enrolled. Enrollment was 40.
Intervention
The intervention was interleukin-2, described as low-dose IL-2 treatment. The registry lists one intervention and one group, titled IL-2 Therapy in SLE. The dose, route, schedule, and duration of treatment are not reported in the registry record.
Comparator
No separate comparator group is listed. The study is recorded as a single-group model, with allocation listed as NA and masking as none. This means the registry record does not describe a randomized, masked comparison against another treatment or a control condition.
Primary question
The primary outcome asks how many participants were SLE responders according to the SRI definition. Response required a reduction of at least 4 points in SELENA-SLEDAI, no new BILAG A score or at most 1 new BILAG B score, and no worsening from baseline of at least 0.3 points in physician global assessment. Assessments were scheduled at week 2, week 4, week 6, week 8, and week 10. The number of responders at these assessments is not reported in the registry record.
3. Trial Design
The registry describes a completed, single-group clinical study of interleukin-2 treatment in systemic lupus erythematosus. It lists enrollment of 40 and names Peking University People's Hospital as the sponsor. The registry lists the study start as 2013-08 and primary completion as 2014-11. The phase is recorded as NA.
Only one group, IL-2 Therapy in SLE, is listed. Allocation is NA, the model is single group, and masking is none. No control arm or randomized allocation is described. Consequently, the design does not offer a concurrent group for separating changes observed during treatment from changes that might have occurred over time, from other care, or from the natural course of the condition. Such limitations apply to interpretation of a single-group study, independent of whether a change is observed.
The intervention is listed as interleukin-2, and the brief description says the study tests low-dose IL-2 treatment in SLE. The registry does not report the treatment dose, route, dosing schedule, treatment duration, eligibility criteria, or the rationale for the planned enrollment. Those details are not reported in the registry record and should not be inferred from the title or group description.
The primary outcome is the number of participants meeting an SRI response definition at week 2, week 4, week 6, week 8, and week 10. The registry also lists secondary outcomes concerning immunological responses, the immunologic impact of treatment, SELENA SLEDAI score, number of relapses, and safety assessment. It records 6 outcome measures and 1 analysis, but does not specify how repeated measurements or secondary outcomes were handled statistically.
The registry status is completed, but completion alone does not establish that all planned participants completed follow-up or that all outcomes were reported. Follow-up completeness, participant disposition, and detailed analysis populations 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: All the patients showed poor efficacy at least 4 weeks of stable routine treatment at the time of enrollment. Two of the enrolled patients withdrew from the study at week 8: one changed to the belimumab treatment by personal preference; the other elected changed to the cyclophosphamide treatment to reduce the frequency of hospital visits.
Overall Study
| Stage | Interleukin-2 |
|---|---|
| STARTED | 40 |
| COMPLETED | 38 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Interleukin-2 |
|---|---|
| Lost to Follow-up | 2 |
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.
| Characteristic | Unit | Interleukin-2 |
|---|---|---|
| Participants analysed | 38 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 38 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 31 (18 to 60) |
| Sex: Female, Male: Female | Participants | 36 |
| Sex: Female, Male: Male | Participants | 2 |
| Region of Enrollment: China | partiipants | 38 |
| SELENA-SLEDAI score | score | 11.35 (SD 3.71) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Were SLE Responders (SRI), measured over week 2，week 4，week 6，week 8，week 10.
| 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 who were SLE responders according to the SRI definition. It combines changes in disease activity with limits on worsening in other assessments. A participant had to meet all stated conditions: a reduction of at least 4 points in SELENA-SLEDAI; no new BILAG A score or at most 1 new BILAG B score; and no deterioration from baseline of at least 0.3 points in physician global assessment.
This composite definition is intended to characterize response across more than one aspect of disease assessment. Requiring all its components means that improvement on one measure alone would not meet the stated response definition if another component crossed its specified worsening threshold. In general, a composite endpoint can capture a broader clinical profile than a single score, but its interpretation depends on the meaning and measurement properties of each component. That is a general statistical and measurement consideration, not a result from this study.
The registry specifies assessments at week 2, week 4, week 6, week 8, and week 10. It does not explain whether the primary endpoint is intended as a separate responder count at each time point, a response at a particular visit, or a summary across visits. The title of the outcome and the listed assessment times do not resolve that issue.
The registry gives the endpoint definition but does not report the number of responders, the denominator assessed at each time, or an uncertainty estimate. The primary endpoint result is therefore not reported in the registry record. Without those results, the extent and precision of any observed response cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically framed primary outcome and a specific responder definition, but it does not report the responder counts at the scheduled assessments. As a result, the central outcome cannot be described as an observed proportion or count from the registry record. No estimate of response, confidence interval, or test result for the primary endpoint is reported in the registry record.
The study is single-group, with no comparator listed. In general, an outcome observed after treatment in a single group describes what occurred among the participants studied; it does not by itself isolate the effect of treatment. Without a concurrent comparison, changes over time may also reflect the course of SLE, other care, measurement variability, or other influences. This is a general limitation of the design, not evidence that any particular influence occurred in this study.
The registry lists enrollment of 40, while the safety record lists 38 participants at risk for each of its displayed adverse-event categories. These figures should not be treated as interchangeable denominators. The registry does not explain the relationship between the enrollment total and the safety denominators, nor does it report participant flow or reasons for any difference. No completion rate or missingness rate can be inferred from those figures without additional information.
For safety, the registry lists 0 participants with serious adverse events among 38 at risk and 5 with other adverse events among 38 at risk. These are descriptive entries. The record does not provide event-level detail, severity descriptions for the other events, attribution to treatment, or a comparative safety estimate. The deaths field is null, which is not the same as a reported count of zero.
The record also lists secondary outcomes related to immunological response, disease activity, relapses, and safety. Their names indicate areas of assessment, but outcome results and analysis details are not reported in the registry record. The record lists 6 outcome measures and 1 analysis; it does not identify the statistical model, specify whether the analysis was adjusted, or explain how repeated assessments were incorporated.
Thus, the available record supports description of the trial design, endpoint definition, assessment schedule, and limited safety counts. It does not support a numerical conclusion about the primary response outcome or a comparative estimate of treatment effect. Any interpretation should remain within those boundaries rather than treating completion status, the study title, or the intended treatment as evidence of an outcome.
9. Statistical Methods Explained
What kind of outcome is the primary endpoint? The primary outcome is a count of participants meeting a binary responder definition: each participant either meets the stated SRI criteria at an assessment or does not. For a binary outcome, results are commonly described using the number meeting the definition and the number assessed. A proportion can also be reported, with an uncertainty interval to show how much precision the data support. These are general ways to present binary outcomes. The registry record does not report the responder counts, denominators, proportions, or uncertainty intervals for this endpoint.
The responder criteria combine three conditions. A participant must have the specified decrease in SELENA-SLEDAI, meet the stated BILAG condition, and avoid the specified deterioration in physician global assessment. This all-conditions requirement defines the endpoint; it is not equivalent to reporting a change in any one component. In general, composite endpoints can be useful when several domains matter to the question, but readers need to know how each component contributes and whether component-level results are available. Component-level results are not reported in the registry record.
How should repeated assessment times be understood? The registry lists week 2, week 4, week 6, week 8, and week 10 for the primary outcome. Repeated measurements can describe how a response outcome changes over follow-up, but they also raise an analysis question: whether each visit is treated as a separate outcome, whether a particular visit is primary, or whether a summary across visits is used. These approaches answer different questions. The registry does not specify which approach was used, and it does not report the corresponding responder results by visit.
In general, repeated observations from the same participant are statistically related rather than independent. An analysis that treats them as independent may not represent that dependence appropriately. Methods for repeated measurements can account for the relationship, but the suitable approach depends on the outcome, timing, missing observations, and prespecified analysis plan. The analysis method for the repeated primary assessments is not reported in the registry record.
What does the single-group design imply? A single-group study can describe outcomes in people who received the intervention. It cannot make a randomized, like-for-like comparison because no separate control group is listed. General causal interpretation is therefore limited: a before-and-after pattern, if reported, would not by itself distinguish treatment-associated change from time trends, concomitant care, regression to the mean, or other factors. These are possible explanations in general, not claims about what happened in this study. No adjusted or causal-effect analysis is reported in the registry record.
What can a confidence interval tell readers? In general, a confidence interval expresses statistical uncertainty around an estimated quantity, such as a responder proportion or a difference between groups. A wider interval indicates less precision, while a narrower interval indicates greater precision under the assumptions of the analysis. It does not guarantee that the underlying value lies within the interval, and it does not resolve limitations in design or measurement. No confidence interval for the primary outcome is reported in the registry record.
What is the role of sample-size planning? A sample-size calculation is a planning exercise based on assumptions about the outcome, a target effect, variability, significance level, power, and design. It is distinct from the observed results and is not a measure of how likely the study was to detect an effect after completion. The registry record does not report the original sample-size justification or its assumptions.
Planning illustrations associated with these results are not the trial's original design calculation. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such assumptions describe an illustrative calculation, not the single-group design recorded for this trial. Any resulting participant counts would be planning illustrations, not observed enrollment or observed power. The single-group record does not contain the two-arm comparison assumed by that illustration, so it should not be read as a reconstruction of the trial's design.
Why can over-dispersion matter? In general, over-dispersion occurs when outcome variability exceeds what a statistical model assumes. If unaccounted for, standard errors may be too small and intervals or tests may appear more precise than warranted. This concept is relevant to some count or rate models, but the registry describes the primary measure as a number of participants with a binary event, and does not report a model or a dispersion estimate. There is therefore no basis in this record to assess over-dispersion for the primary analysis.
What is known about the analysis? The registry lists 1 analysis, but does not report its method, estimand, covariates, testing procedure, or handling of repeated observations. It also does not identify whether the analysis was prespecified or whether any sensitivity analyses were conducted. Those details are not reported in the registry record. A count of analyses is not a substitute for the statistical analysis plan, and it does not establish that only one statistical comparison was performed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 6 outcome measures, including the primary responder outcome and secondary outcomes concerning immunological responses, SELENA SLEDAI score, relapses, and safety. It also lists several primary-outcome assessment times. When multiple outcomes or repeated time points are examined, the chance of finding an apparently notable result by chance can increase if many tests are performed. In general, a prespecified hierarchy, a defined primary time point, or an adjustment procedure can help clarify how multiple comparisons are handled.
The registry record does not report whether an adjustment for multiplicity was planned or used. It does not state whether one of the listed primary assessment times was designated as the principal time point, how the secondary outcomes were ranked, or whether any outcome analyses were exploratory. The listed count of outcome measures and analyses does not answer those questions.
The registry does not report the amount or pattern of missing outcome data, the number assessed at each visit, or how missing observations were handled. It also does not describe an analysis population, such as whether analyses included all enrolled participants, participants who received treatment, or only those with available measurements. These details are not reported in the registry record.
These omissions matter because the denominator and treatment of missing data affect how a responder count should be interpreted. If follow-up availability differs across visits, the counts assessed at each time may not represent the same group of participants. No such pattern should be presumed without the participant-level flow and analysis details. The enrollment total and the safety denominators do not establish the primary-outcome denominators.
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 |
|---|---|---|---|
| IL-2 Therapy in SLE | 0 | 38 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| IL-2 Therapy in SLE | 5 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IL-2 Therapy in SLE |
|---|---|---|
| Injection-site reaction | Skin and subcutaneous tissue disorders | 5 of 38 |
| Fatigue | General disorders | 1 of 38 |
| Fever | General disorders | 1 of 38 |
The registry lists 38 participants at risk in the IL-2 Therapy in SLE group for the serious adverse-event category and records 0 affected. It also lists 38 at risk for other adverse events and records 5 affected. These are the counts entered in the safety record; they do not establish the nature, timing, duration, or clinical importance of individual events.
The safety record does not list serious adverse-event terms. It does not describe how events were collected, whether events were judged related to treatment, or how severity was classified. The number of deaths is null, so deaths are not reported as a numeric result; null should not be interpreted as zero.
The safety denominators are 38, whereas enrollment is listed as 40. The registry does not explain this difference. It is not possible to infer from the record why the denominators differ or whether all enrolled participants were exposed, followed, or assessed for safety.
Because the study lists only one group, these safety counts are descriptive and have no concurrent comparator in the registry record. They cannot establish comparative safety, and the absence of recorded serious adverse events does not establish that no risk exists. The posted figures should be read as limited registry reporting rather than a complete account of safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group study of low-dose interleukin-2 in SLE was registered with enrollment of 40. It specifies an SRI responder definition and assessment times from week 2 through week 10. It also includes limited safety counts for participants at risk. These details describe the study question and some recorded outcomes, but they do not supply the primary efficacy result.
The number of SRI responders at each assessment is not reported in the registry record. Without those counts and their denominators, it is not possible to describe the observed response frequency or its statistical precision. The record also does not report a confidence interval or a statistical test for the primary outcome.
Even if a change from baseline were available, a single-group design would not establish that treatment caused the change. Without a concurrent comparator, other influences and the course of the condition cannot be separated from treatment-associated change using this design alone. This is a general design limitation and not a claim that any particular alternative explanation occurred.
The safety entries report 0 serious adverse events among 38 at risk and 5 other adverse events among 38 at risk. They do not include enough detail to establish event type, attribution, or a comparative safety profile. The deaths entry is null, not a reported zero. The enrollment and safety denominators should not be combined to infer participant flow because the registry does not explain their relationship.
The findings therefore do not support a conclusion about how often participants met the responder criteria, how precisely any effect was estimated, or whether the intervention was better than another approach. They also do not establish an absence of safety concerns. The appropriate interpretation is limited to the design, endpoint definition, and numerical safety entries actually recorded, while recognizing that important outcome and analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because it pairs a defined composite responder endpoint with a single-group design. The SRI criteria make clear what qualifies as response, incorporating disease activity, BILAG status, and physician global assessment. A precise endpoint definition is important for reproducibility: it helps readers understand what the outcome is intended to represent and what conditions a participant must meet.
At the same time, a detailed definition cannot substitute for reported outcome data. The responder counts and denominators at the specified assessment times are not reported in the registry record. This makes the distinction between a well-described outcome and an interpretable result especially clear. Without the result and its uncertainty, neither the frequency of response nor the precision of an estimate can be evaluated.
The single-group model is also important statistically. It can describe what was observed in the treated group, but it does not provide the randomized comparison needed to distinguish treatment-associated outcomes from other changes over time. This is a design property, not a judgment about the conduct of the study.
The registry includes safety counts but leaves relevant context unreported, including event details, attribution, participant flow, and the meaning of the difference between enrollment and safety denominators. The record also does not describe multiplicity handling, missing-data methods, or the primary analysis plan. These elements affect how confidently outcomes can be interpreted.
For clinical researchers and statisticians, the key lesson is that endpoint definitions, design, denominators, analysis methods, and complete outcome reporting all contribute to evidential meaning. A completed status and a registered question are not substitutes for the observed primary results or a comparison group. This record illustrates how much interpretation depends on details beyond the study title and outcome definitions.
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 most consequential limitation for interpreting the primary endpoint is that responder results are not reported in the registry record. The listed assessment schedule does not identify which visit, if any, was the main endpoint time for analysis. The record also does not report the number assessed at each visit, so the denominator for a responder count cannot be established.
The single-group design has no concurrent control group listed. As a result, the record cannot support a randomized comparison or separate treatment-associated change from other possible influences. Allocation is listed as NA and masking as none. The registry does not report whether other procedures were used to reduce bias in outcome assessment.
Important treatment and population details are absent, including the dose, route, schedule, duration, eligibility criteria, and baseline participant characteristics. The reason for the planned enrollment is not reported in the registry record. These omissions limit assessment of how the study was conducted and to whom its observations might apply.
The registry lists 6 outcome measures and 1 analysis but does not provide the analysis method, the primary analysis population, multiplicity approach, or missing-data strategy. It does not state how the repeated primary assessments were treated statistically. The number of analyses recorded does not resolve these methodological questions.
Safety reporting is also limited. The record lists 0 serious adverse events and 5 other adverse events among 38 at risk in the respective categories, but gives no event descriptions or treatment attribution. Deaths are not reported as a numeric count. The relationship between enrollment of 40 and the safety denominators of 38 is not explained, and participant disposition is not reported. These limitations prevent a fuller assessment of outcome completeness and safety context.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Low-dose IL-2( Interleukin-2) Treatment in SLE — NCT02084238.
- Registry record last updated 2020-04-03; status last verified 2020-03.
- Results first posted 2015-04-13.
- 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 record describes a completed, single-group study of low-dose interleukin-2 in systemic lupus erythematosus, sponsored by Peking University People's Hospital. Enrollment is listed as 40; the phase and allocation are listed as NA, and masking is none. The primary endpoint is the number of participants meeting a specified SRI responder definition at week 2, week 4, week 6, week 8, and week 10.
The primary responder counts and analysis results are not reported in the registry record. Safety entries list 0 serious adverse events and 5 other adverse events among 38 at risk for the respective categories. The deaths field is null. Details on participant flow, missing data, analysis methods, multiplicity, and the relation between enrollment and safety denominators are not reported in the registry record.