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 Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis (NCT00477191), a na na study. The primary outcome is Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00477191 |
| Phase | NA |
| Condition | Psoriasis, Metabolic Syndrome, Hyperlipidemia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with psoriasis and metabolic syndrome. The registry also lists hyperlipidemia, obesity, and hypertension among the conditions. The brief summary describes metabolic syndrome in terms of insulin resistance, increased waist size, high blood pressure, or high cholesterol. It does not give detailed eligibility criteria, baseline characteristics, or the number of participants who contributed data to the primary outcome.
Intervention
The listed intervention is etanercept, a drug. The primary outcome timeframe is 6 months of treatment. The record does not report the treatment dose, schedule, adherence, or whether participants received other study-related care. Those details cannot be inferred from the intervention name alone.
Comparator
The study is identified as a single-group study, with allocation and masking recorded as NA and NONE, respectively. No separate control group is described. It therefore does not provide a like-for-like comparison between etanercept and another treatment or no treatment.
Primary question
The primary question is whether C-reactive protein (CRP) levels changed from baseline to 6 months in subjects with psoriasis and metabolic syndrome receiving etanercept. CRP is an inflammatory marker, so its change is a biological outcome rather than a direct measure of heart disease. The registry record specifies the outcome but does not report the observed change, its uncertainty, or an analysis result.
3. Trial Design
The registry describes a single-group study of etanercept in people with psoriasis and metabolic syndrome. Its allocation is recorded as NA, and masking as NONE. The record does not describe a randomized comparison or a control group; the study should not be read as a controlled treatment comparison. The phase is recorded as NA.
The listed enrollment is 18. That is the registry enrollment figure, not confirmation of how many participants completed treatment, contributed a primary-outcome measurement, or were included in an analysis. Those analysis-population details are not reported in the registry record. Massachusetts General Hospital is listed as the sponsor.
The study start is recorded as 2007-05 and primary completion as 2013-12. Its status is TERMINATED. The registry does not report why the study was terminated, and the status alone does not establish whether the planned enrollment or follow-up was completed.
The named primary outcome is change in CRP from baseline to 6 months, expressed in ng/mL. The record also lists change in plasma glucose, change in endothelial function measured using the reactive hyperemia index, and change in safety and tolerability over a 6-month period. These listed outcomes describe what was registered; they do not establish that measurements were collected or analyzed. The registry records four outcome measures and zero analyses. No outcome estimates or inferential results are reported.
Because this is a single-group study, any change over time would be a within-group observation. Without a concurrent control group, such a change cannot by itself distinguish an effect of etanercept from changes that might occur over time for other reasons. The registry does not report design details that would resolve that limitation.
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.
Overall Study
| Stage | Etanercept |
|---|---|
| STARTED | 18 |
| COMPLETED | 13 |
| NOT COMPLETED | 5 |
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: Psoriasis patients with MetS
| Characteristic | Unit | Etanercept |
|---|---|---|
| Participants analysed | 18 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 43.5 (SD 11.6) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 13 |
| Region of Enrollment: United States | participants | 18 |
| BMI | kg/m^2 | 38.9 (SD 5.6) |
| Psoriasis Area Severity Index (PASI) | units on a scale | 16.9 (SD 1.5) |
6. Primary Endpoint
The registry lists the primary outcome as Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in C-reactive protein (CRP) levels from baseline to 6 months of treatment in subjects with psoriasis and metabolic syndrome. The record identifies the measure as a mean, with standard deviation as the dispersion measure, and gives the unit as ng/mL. It describes the endpoint as the difference in CRP levels between baseline and month 6.
CRP is an inflammatory marker. In general, measuring it can help characterize systemic inflammation, which is relevant to a study asking how inflammatory markers relate to heart-disease risk. A change in CRP is a biological measure, however, and is not itself a measurement of heart disease, a cardiovascular event, or a participant’s overall health. It should not be interpreted as establishing a clinical benefit or harm.
The registry record does not report the observed mean change, the standard deviation of the change, a confidence interval, a p-value, or the number of participants with measurements at both time points. It also does not specify how missing measurements were handled or which analysis population was used. Consequently, the endpoint is defined, but its size, precision, and statistical significance cannot be assessed from the registry results reported.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that this was a terminated, single-group study of etanercept in people with psoriasis and metabolic syndrome, with change in CRP from baseline to 6 months specified as the primary outcome. It does not provide the primary outcome estimate or any analysis results. The record therefore does not show the direction or size of CRP change, how variable the measurements were, or how precisely any change was estimated.
There are no reported p-values or confidence intervals for the primary outcome. Without an estimate and a measure of uncertainty, the result cannot be evaluated for its compatibility with different possible changes. A confidence interval, in general, describes uncertainty around an estimated quantity; it does not replace the estimate or establish a causal effect. No such interval is reported in the registry record.
The absence of a control group is central to interpretation. Even if a before-and-after change were reported, a single-group comparison could not separate a treatment-related change from time trends, changes in other care, measurement variation, or other influences. This does not mean that change could not be measured; it means that the design does not provide a concurrent counterfactual comparison. The registry itself flags that this is not a randomized comparison and that its arms are not a like-for-like control comparison.
The record lists change in plasma glucose, endothelial function measured using the reactive hyperemia index, and safety and tolerability as secondary outcomes. It does not report their results or analyses. The registry lists four outcome measures and zero analyses, so there is no reported statistical evidence with which to assess those outcomes or compare their findings with the primary outcome.
Enrollment is listed as 18, while the safety figures use 13 participants at risk in each of the reported categories. The record does not explain the difference between these figures. The enrollment count should not be treated as the analysis denominator for CRP or as proof that every enrolled participant completed follow-up.
Any sample-size calculations accompanying the study are planning illustrations based on an observed effect, not evidence of the study’s original design or observed power. No observed primary effect is reported in the registry record, so such calculations cannot fill the gap in outcome reporting. Overall, the posted record describes the study question and design but does not establish an outcome result.
9. Statistical Methods Explained
The registry characterizes the primary outcome as continuous and specifies a mean with standard deviation. Those choices describe the type of summary intended; they do not supply the underlying observations or the result. No analysis is listed in the registry record.
What does a mean change describe?
In general, a mean summarizes the average value in a group. For a change endpoint, the relevant quantity is the average change between the stated measurement times. The registry names baseline and 6 months, and describes the outcome as the difference in CRP levels. It does not report the calculated mean change, the participant-level data, or the exact computational procedure. In particular, it does not state whether the estimate was calculated only among participants with both measurements or handled missing measurements in another way.
What does the standard deviation describe?
In general, a standard deviation describes how spread out individual observations are around their mean. It is not the same as a standard error or a confidence interval. A standard deviation for an outcome can describe variability among individual measurements or changes, depending on what was calculated. The record identifies standard deviation as the dispersion measure but does not report a value or clarify the detailed calculation. Without the estimate and its dispersion, readers cannot assess how heterogeneous participant changes were.
What would a confidence interval add?
In general, a confidence interval conveys the statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while the interval’s location helps describe which values remain compatible with the data and method. A confidence interval does not correct a weak design or prove causality. The registry does not report a confidence interval for the CRP outcome, nor does it report an inferential analysis from which one could evaluate the result.
Why does the single-group design matter?
In general, measuring participants before and after an intervention can describe within-group change. Without a concurrent control group, the observed change cannot isolate the intervention from other explanations, including natural change over time or differences in measurement conditions. The registry identifies the model as SINGLE GROUP and does not describe a separate comparator. Its own record cautions that the study is not a randomized comparison and that arms are not a like-for-like control comparison. A within-group estimate, if reported, would answer a different question from a randomized treatment contrast.
What can sample-size planning calculations say?
General sample-size calculations estimate how many participants might be needed to detect a specified effect under stated assumptions. The planning assumptions associated with this record use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These calculations are planning illustrations, not the trial’s own design, and they do not represent observed power. They also do not turn a single-group study into a controlled comparison. The registry does not report a sample-size justification for the original study or the analysis results required to evaluate its observed effect.
What analysis details are absent?
The registry lists zero analyses. It does not report a statistical model, standard error, p-value, confidence interval, adjustment for baseline variables, handling of repeated measurements, or a prespecified analysis population. These methods can affect an estimate and its uncertainty, so they should not be guessed. Over-dispersion is a general issue for some count outcomes when variability exceeds what a simple model assumes, but the primary outcome is continuous; the registry provides no reason to apply a count-data model. The stated outcome summaries alone do not identify the statistical test or model used.
These methods explain what the recorded endpoint and summary choices mean in general. They cannot substitute for the missing numerical outcome estimate and analysis details. Accordingly, the registry record supports a description of the planned measurement, not a statistical conclusion about the change in CRP.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Etanercept | 13 | 5.300 | 4.200 | 2.762 to 7.838 |
R code and output
arm <- c("Etanercept")
n <- c(13)
m <- c(5.3)
sp <- c(4.2)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Etanercept 13 5.300 4.200 2.762 7.83811. Multiplicity, Missing Data and Analysis Populations
The record identifies a primary CRP outcome and lists changes in plasma glucose, endothelial function measured using the reactive hyperemia index, and safety and tolerability as secondary outcomes. It records four outcome measures. When a study evaluates multiple outcomes, general statistical practice may address the increased chance of a chance finding through a prespecified multiplicity strategy. The registry does not report whether any such strategy was planned or used. It also reports zero analyses, so there are no outcome-specific inferential results to interpret.
Missing-data information is not reported in the registry record. The record does not state how many participants had baseline and 6-month CRP measurements, why measurements may have been absent, or whether any imputation or other missing-data method was used. It would be inappropriate to assume that all enrolled participants contributed complete data.
The analysis population is also not reported. The listed enrollment is 18, while the safety categories report 13 at risk; the registry does not explain how these figures relate to follow-up or analysis sets. No intention-to-treat, per-protocol, or other population is specified, and none should be inferred from the single-group design. These omissions limit assessment of both the representativeness of the analyzed data and the robustness of any potential outcome estimate.
The registry does not provide a statistical analysis plan, the timing of any analyses, or a description of interim analyses. Those elements are not reported in the registry record. Without them and without results, readers cannot assess whether outcome selection, multiplicity handling, or missing-data decisions could have influenced the reported conclusions.
12. 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 |
|---|---|---|---|
| Etanercept | 0 | 13 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Etanercept | 4 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Etanercept |
|---|---|---|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | 1 of 13 |
| Headache | Nervous system disorders | 1 of 13 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | 1 of 13 |
| Viral Gastroenteritis | Gastrointestinal disorders | 1 of 13 |
| Sore throat | Respiratory, thoracic and mediastinal disorders | 1 of 13 |
The registry reports safety figures for the etanercept group. In the serious adverse-event category, 13 participants are listed as at risk and 0 as affected. In the other adverse-event category, 13 are listed as at risk and 4 as affected. Deaths are not reported in the registry record, and no serious adverse-event terms are listed.
These are counts for the categories as recorded, not a complete account of the nature, timing, severity, or duration of events. The record does not define the observation period for these figures or explain whether the same participants contributed to both categories. It also does not explain why the safety denominator differs from the enrollment figure of 18.
A recorded zero affected in the serious category means that no affected participants are listed in that category; it does not establish that the risk of a serious event is absent. The 4 affected in the other category should not be interpreted as an event count, because the record reports affected participants rather than the number of separate events. With no comparator and limited reporting detail, these figures do not support a comparative safety conclusion.
13. What the Result Does, and Does Not, Mean
The record establishes that a study of etanercept in people with psoriasis and metabolic syndrome was registered as a single-group study and that change in CRP from baseline to 6 months was its primary outcome. It also establishes that the status is TERMINATED, the listed enrollment is 18, and the registry reports zero analyses. These registry entries describe the registered study, not its efficacy or clinical impact.
The primary endpoint is a biological marker, not a direct measure of heart disease. Even a reported change in CRP would need to be interpreted in light of its uncertainty, the measurement process, and the lack of a control group. The registry does not report the change or its precision, so the magnitude and direction cannot be assessed. There are no reported analyses for the listed secondary outcomes either.
The study does not establish whether etanercept changes CRP relative to no treatment or another intervention, because no like-for-like control comparison is described. The record also does not establish an effect on cardiovascular risk, cardiovascular events, or other clinical outcomes. Its stated focus on inflammatory markers and heart-disease risk is a research question, not a result.
The safety figures report zero participants affected in the serious category and 4 affected in the other category among 13 listed at risk for each. These counts do not, by themselves, establish comparative safety or the absence of risk. The registry does not report deaths, event terms, or enough follow-up and analysis detail to support broader conclusions.
In general, a study’s design and reported results determine what can be concluded. Here, the design information is available, but outcome estimates and analyses are not. The appropriate interpretation is therefore limited to the registered question, design, and sparse safety counts; no treatment-effect conclusion can be drawn from the registry record.
14. Why This Trial Matters Statistically
This study is statistically notable because the primary question concerns change over time, while the registered model is single-group. A before-and-after measure can describe what happened within the observed group, but it cannot alone establish what would have happened over the same period without the intervention. That distinction is important whenever a biological marker is used to explore a possible link with broader clinical risk.
The outcome is defined with useful measurement details: CRP, change from baseline to 6 months, a mean summary, standard deviation for dispersion, and ng/mL as the unit. Those specifications identify the intended estimand at a basic level. They do not show its value. The absence of an estimate, uncertainty interval, and analysis leaves the central statistical question unanswered in the registry results.
The record also illustrates why enrollment, safety denominators, and analysis populations must not be treated as interchangeable. Enrollment is listed as 18, while the safety figures list 13 at risk. The record does not explain the relationship, and the primary-outcome analysis population is not reported. Readers cannot assume that enrollment equals completion or that the safety denominator applies to the primary endpoint.
Finally, listing multiple outcomes makes multiplicity and selective reporting relevant considerations, but the registry does not report a multiplicity approach or any analyses. These gaps do not prove that a particular analysis was inappropriate; they limit what can be evaluated from the record. Statistically, the study’s importance lies in the difference between a specified research question and a reported, interpretable estimate. The former is present; the latter is not.
15. 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 has important limitations for interpreting this study. It identifies the study as single-group, with no separate control described, and therefore does not support a randomized treatment comparison. Any within-group change, if it had been reported, could not by itself isolate the effect of etanercept from other influences over time.
The study status is TERMINATED, but the reason for termination is not reported in the registry record. The listed enrollment is 18; the record does not state how many participants completed the 6-month period or contributed to the primary outcome. The safety categories list 13 at risk, and the relationship between those figures and enrollment is not explained.
The primary outcome is named and defined by measure, timeframe, summary, dispersion type, and unit, but its result is not reported. There are no reported analyses, confidence intervals, or p-values. Missing-data handling, the analysis population, and the statistical model are not reported either. These omissions prevent assessment of the estimate’s precision, analysis assumptions, or sensitivity to missing observations.
The record lists secondary outcomes, but does not give their results or report a multiplicity strategy. It also does not provide detailed eligibility criteria, baseline characteristics, treatment dose or schedule, adherence, or the reason for termination. These details should not be inferred. The safety reporting is limited to affected-participant figures, with no serious-event terms listed and deaths not reported in the registry record. Taken together, the available information describes the study question and some design and safety details, but is insufficient for evaluating clinical effects or comparative safety.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis — NCT00477191.
- Registry record last updated 2016-05-16; status last verified 2016-04.
- Results first posted 2016-05-16.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry record describes a study sponsored by Massachusetts General Hospital, with a start date of 2007-05 and primary completion recorded as 2013-12. The status is TERMINATED. The listed enrollment is 18, and the phase is recorded as NA.
The study is single-group, with allocation recorded as NA and masking as NONE. Etanercept is the listed intervention. The primary outcome is change in CRP from baseline to 6 months, summarized as a mean with standard deviation and measured in ng/mL. Secondary outcomes concern plasma glucose, endothelial function measured using the reactive hyperemia index, and safety and tolerability.
The registry lists four outcome measures and zero analyses. It does not report the primary or secondary outcome results, the reason for termination, the analysis population, or missing-data methods. Safety figures list 13 at risk and 0 affected in the serious category, and 13 at risk and 4 affected in the other category; deaths are not reported in the registry record. The study record defines a research question but does not provide outcome analyses from which to assess a treatment effect.