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 of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis (NCT01126619), a registered phase not stated study. The primary outcome is Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01126619 |
| Phase | Phase not stated |
| Condition | Psoriasis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 103 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Abbott |
| Results posted | Yes |
2. Clinical Question
Population
Participants with moderate to severe psoriasis who received anti-TNF treatment and completed follow-up through Week 24. The registry reports enrollment of 103 participants; the primary-outcome population is described specifically as those completing the scheduled follow-up.
Intervention
Anti-TNF treatment. Participants had been prescribed an anti-TNF agent before enrollment, according to national approved indications and reimbursement guidelines. The registry does not name individual agents or report treatment regimens.
Comparator
No comparator group is described. The registry lists an Anti-TNF group and does not state an allocation method. The record therefore does not establish a like-for-like control comparison.
Primary question
The primary question concerns the percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at Baseline and Weeks 4, 8, 16 and 24 among participants receiving anti-TNF treatment. The registry describes the outcome but does not report numerical PASI results, so the amount or precision of any change cannot be assessed from the record.
The study is described as observing the effectiveness and safety of tumor necrosis factor inhibitors in moderate to severe psoriasis. Its stated context is the use of biologics alongside the continuing role of traditional systemic therapies in Turkey. The record does not describe a randomized treatment assignment or a control group, so the clinical question is about change observed among treated participants rather than a treatment contrast against a separate group.
3. Trial Design
The registry describes a completed study of anti-TNF agents in participants with moderate to severe psoriasis. Enrollment was 103. The recorded start was 2010-05, and primary completion was 2011-09. Abbott is listed as the sponsor. The study is presented as an observation of effectiveness and safety, rather than as a randomized comparison.
The listed group comprises participants prescribed an anti-TNF agent before enrollment under national approved indications and reimbursement guidelines. Allocation is not stated. No like-for-like control arm is described, and the record cautions that the arms are not a randomized comparison. It does not report how clinicians selected a particular agent, whether participants could change treatment, or the duration and dosing of individual regimens.
The primary outcome is percentage change from baseline in PASI score, with assessments specified at Baseline and Weeks 4, 8, 16 and 24. The primary-outcome population is described as participants who received anti-TNF treatment and completed follow-up through Week 24. The record does not say how many participants met that description or how participants with incomplete visits were handled.
Named secondary outcomes include physician and patient global assessments, static physician assessment, change in Dermatology Life Quality Index, change in Work Productivity and Activity Impairment, and adverse events. Although the registry reports eight outcome measures overall, the analysis details and numerical results are not reported in the registry record. The protocol, eligibility criteria beyond the described psoriasis severity and prescribing context, and statistical plan are also 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.
Overall Study
| Stage | Anti-TNF |
|---|---|
| STARTED | 103 |
| COMPLETED | 86 |
| NOT COMPLETED | 17 |
Reasons for not completing this period:
| Reason | Anti-TNF |
|---|---|
| Not eligible for the study | 2 |
| Investigator decision | 4 |
| Serious adverse event | 1 |
| Withdrawal by Subject | 9 |
| Non-compliance | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
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 | Anti-TNF |
|---|---|---|
| Participants analysed | 103 | |
| Age Continuous | years | 44.9 (SD 13.9) |
| Gender: Female | participants | 40 |
| Gender: Male | participants | 62 |
| Region of Enrollment: Turkey | participants | 103 |
| Weight | kg | 78.5 (SD 16.0) |
| Height | cm | 166.9 (SD 13.5) |
| Body Mass Index (BMI) | kg/m^2 | 29.3 (SD 14.9) |
| Psoriasis Area and Severity Index (PASI) Score | scores on a scale | 20.8 (SD 11.2) |
| Dermatology Life Quality Index (DLQI) Score | scores on a scale | 15.1 (SD 7.3) |
| Duration of Psoriasis | years | 15.7 (SD 9.2) |
6. Primary Endpoint
The registry lists the primary outcome as Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score, measured over Baseline and Weeks 4, 8, 16 and 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score, assessed at Baseline and Weeks 4, 8, 16 and 24. PASI combines clinical assessments of erythema, induration and desquamation with the percentage of affected body area. The score is assessed across the head, arms, trunk and legs. A higher total PASI score indicates more severe disease.
Expressing change as a percentage of baseline relates the follow-up value to each participant’s starting score. In general, a percentage change can help describe the scale of change relative to baseline when participants begin with different scores. The registry defines the endpoint as a mean of a continuous measure and specifies standard deviation as its dispersion measure. Those summaries could describe the average change and the spread of participant-level changes, but the numerical estimates are not reported in the registry record.
The outcome is used to track psoriasis severity over scheduled follow-up. Its interpretation depends on the starting values, the completeness of follow-up and the way missing measurements are handled. The registry identifies a primary population that completed follow-up through Week 24, but does not report the number assessed at each visit or the methods used for missing observations. The endpoint description is therefore clear about what was intended to be measured, while the posted record does not provide the results needed to judge the observed pattern or its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry specifies a clinically interpretable primary measure and a schedule of assessments, but it does not report numerical PASI outcomes. There is no posted mean percentage change, standard deviation, confidence interval, or analysis estimate for the primary endpoint. Consequently, the magnitude, direction and precision of change cannot be assessed from the registry record. The outcome description alone is not evidence that PASI scores changed by any particular amount.
The listed primary-outcome population consists of participants who received anti-TNF treatment and completed follow-up through Week 24. This is a completion-based description. The number of participants included in that population and the number assessed at the earlier visits are not reported in the registry record. If participants with incomplete follow-up differ from those who complete it, a completer summary may not represent all enrolled participants. The record does not report an approach to evaluating that possibility.
The study does not describe a randomized control comparison. Treatment was prescribed before enrollment, and allocation is not stated. A change over time in the treated group, even if numerical results were available, would not by itself isolate the contribution of treatment from other influences. General considerations include natural variation in disease, changes in other care, and differences among participants; the registry does not report analyses addressing these possibilities. This limits causal interpretation and means the record should be read as an observational account rather than as a controlled estimate of a treatment contrast.
The registry reports adverse-event counts for the Anti-TNF group, but the event figures do not establish a comparative safety effect. The record lists 3 participants with serious adverse events and 7 with other adverse events among 103 at risk for each category. It also names serious-event terms with reported percentages. No deaths are reported in the posted safety figures. These data describe what the record lists; without further detail about event definitions, follow-up completeness, attribution or comparison, they cannot establish the cause or comparative likelihood of events.
There are eight outcome measures recorded, with several named secondary outcomes. The registry reports zero analyses. It does not provide inferential results for the primary or secondary measures, or a multiplicity strategy. Thus, the posted record supports a description of study intent, endpoint definitions and selected safety counts, but not a statistical conclusion about the size or reliability of a treatment effect.
9. Statistical Methods Explained
The primary measure is continuous: it is a percentage change in PASI score, summarized as a mean with standard deviation. A mean describes the average value in the analyzed group. A standard deviation describes how dispersed individual values are around that average; it is not the same as uncertainty about the mean. The registry does not report the mean or standard deviation for the primary outcome, so neither the average change nor its variability can be evaluated from the posted results.
In general, a confidence interval expresses uncertainty around an estimate and gives a range of values compatible with the data under the method’s assumptions. It is not reported for the primary outcome in the registry record. A p-value, when reported, addresses compatibility with a specified null hypothesis under an analysis model; it does not measure clinical importance or the probability that a hypothesis is true. The registry lists no analyses, and no p-value for the primary outcome is reported. Without estimates and uncertainty measures, statistical precision cannot be judged.
The registry specifies repeated assessment at Baseline and Weeks 4, 8, 16 and 24. In general, repeated measurements can show how an outcome evolves over time, but analyses need to account for the fact that measurements from the same participant are related. The registry record does not report an analysis model, whether changes were assessed separately at each visit, or how within-participant correlation was handled. It also does not provide visit-specific participant counts or numerical results.
The record gives the endpoint formula in words as baseline value minus post-baseline value divided by baseline value, multiplied by 100. This is the stated percentage-change measure. The exact numerical PASI data and calculations are not posted, so the reported formula cannot be checked against participant-level values. No recalculated estimates are reported in the registry record. Where a sponsor analysis and a simple recalculation differ, the sponsor’s own analysis takes precedence; the posted record does not contain an analysis estimate to compare in this case.
General planning illustrations can help show how sample size depends on an assumed effect, variability, significance level and allocation. They are not observed results and are not evidence of the study’s achieved power. The record states that any planning illustration is based on a fraction of the observed effect and uses a two-sided significance level of 0.05, equal allocation and a normal approximation. It does not report the trial’s own sample-size justification or design assumptions. Numerical planning values are not stated in the registry record, so no participant requirement can be inferred from those details.
Over-dispersion is a general concern when outcome variability is greater than a statistical model assumes. If ignored, uncertainty can be understated and tests can appear more decisive than warranted. The registry identifies standard deviation as the primary measure’s dispersion but does not report a model or diagnostics, so there is no basis to determine whether over-dispersion was relevant or assessed. For this continuous outcome, the key missing information is the observed variability and the analysis method used to account for it.
The treatment group was formed from participants already prescribed anti-TNF agents, and the record does not state allocation. General statistical interpretation therefore needs to distinguish change observed over time from a causal effect attributable to treatment. A control group, randomization details and adjustment methods are not reported in the registry record. The record also does not report whether baseline characteristics were used to adjust estimates or how differences in treatment selection were considered.
Finally, the registry records eight outcome measures, including the primary PASI measure and named secondary measures. Testing or interpreting multiple outcomes can increase the chance of finding apparently notable results by chance if multiplicity is not addressed. The registry does not report a multiplicity method, a hierarchy among secondary outcomes or analysis results. Since no analyses are listed, there are no posted inferential results to assess for multiplicity or model assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry records eight outcome measures. It identifies percentage change in PASI as the primary outcome and names secondary outcomes covering dynamic physician and patient global assessments, static physician global assessment, Dermatology Life Quality Index, Work Productivity and Activity Impairment, and adverse events. The registry does not report a hierarchy for secondary outcomes or a plan for controlling multiplicity.
In general, when several outcomes or time points are examined, the chance of a seemingly notable finding can increase if each is interpreted as a separate confirmatory test. A prespecified hierarchy or multiplicity adjustment can help address that issue. Neither such a plan nor inferential results are reported in the registry record. The record lists zero analyses, so there are no posted outcome tests to evaluate.
The primary-outcome population is described as participants who received anti-TNF treatment and completed follow-up through Week 24. The number completing follow-up is not reported in the registry record. Nor are the numbers with available measurements at each visit, reasons for missing data, imputation methods, or sensitivity analyses. Missing-data handling is therefore unclear, and the effect of incomplete follow-up on the reported endpoint cannot be assessed.
The registry does not report a broader intention-to-treat population or another analysis population definition beyond the completion-based primary description. It also does not report how participants who discontinued treatment or missed visits were treated in analyses. These omissions matter because analysis populations and missing-data assumptions determine which observations contribute to an estimate and how broadly that estimate can be interpreted.
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 |
|---|---|---|---|
| Anti-TNF | 3 | 103 | 2.9% |
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 |
|---|---|
| Anti-TNF | 7 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | Anti-TNF |
|---|---|---|
| Hepatotoxicity, Toxic Hepatitis | Gastrointestinal disorders | 1 of 103 |
| Gangrenous emphysema | Respiratory, thoracic and mediastinal disorders | 1 of 103 |
| Catheter infection, infected endocarditis | Infections and infestations | 1 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Anti-TNF |
|---|---|---|
| Injection site reaction | General disorders | 7 of 103 |
Serious events with the highest arm-level rate: hepatotoxicity, toxic hepatitis (1.0%), gangrenous emphysema (1.0%), catheter infection, infected endocarditis (1.0%).
The registry lists 103 participants at risk for serious adverse events and reports 3 affected participants. For other adverse events, it lists 103 at risk and 7 affected participants. These are counts for the Anti-TNF group, not a comparison with a control group. The record does not report an analysis that would establish whether the observed counts were higher or lower than they would have been without treatment.
The serious-event terms listed are “Hepatotoxicity, Toxic Hepatitis” at 1.0%, “Gangrenous emphysema” at 1.0%, and “Catheter infection, infected endocarditis” at 1.0%. These are the terms and percentages recorded; the registry does not give further detail about event timing, severity grading, attribution to treatment, or whether terms are grouped. Deaths are not reported in the registry record.
Adverse-event counts describe events recorded during the study, not proof that treatment caused them. Interpretation also depends on the observation period, how events were collected and coded, and whether follow-up was complete. Those details are not reported in the registry record. The figures should therefore be read as descriptive safety information for the listed group, not as a comparative estimate or a complete account of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that a study was conducted to observe effectiveness and safety of anti-TNF agents in participants with moderate to severe psoriasis. It identifies percentage change in PASI score as the primary outcome and specifies assessments through Week 24. It also records selected adverse-event counts and names several secondary outcomes. These details describe the study’s scope, but numerical results for the primary outcome are not reported in the registry record.
The absence of PASI estimates means the registry record cannot establish the average change observed, how variable individual changes were, or how precisely any estimate was measured. It also does not permit an assessment of statistical significance or clinical importance. A defined endpoint and assessment schedule do not substitute for outcome results.
The study has no described randomized comparator, and allocation is not stated. Accordingly, even a reported change among treated participants would not, on its own, show how outcomes would have differed without treatment. The record does not provide a control-group contrast or statistical adjustment that could address this issue. Its design and posted information support a descriptive reading, not a causal conclusion.
The safety counts are also descriptive. They do not establish that an event was caused by anti-TNF treatment, nor do they show comparative safety in the absence of a control group. The registry does not report deaths in the safety figures, but that should not be interpreted as evidence that no deaths occurred outside the reported information.
Overall, the record tells readers what outcome was intended, who was included in the stated primary population and which safety counts were posted. It does not report enough outcome or analysis information to quantify effectiveness, judge statistical precision, or draw a comparative benefit or risk conclusion.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between an explicitly defined outcome and the absence of reported outcome estimates. The registry specifies PASI percentage change, a continuous measure, and a follow-up schedule through Week 24. Such detail identifies what investigators intended to measure, but it does not reveal the observed mean, variability or uncertainty. Without those results, readers cannot evaluate the primary endpoint quantitatively.
The record also illustrates why study design matters alongside outcome choice. Participants were prescribed anti-TNF agents before enrollment, and allocation is not stated. No like-for-like control comparison is described. In general, changes measured in a treated group can reflect more than treatment alone, so a before-and-after description should not be read as an isolated treatment effect. The registry does not report analyses that would resolve this limitation.
The completion-based description of the primary-outcome population raises a separate interpretive issue. If follow-up is incomplete, the estimate among participants completing visits may differ from the experience of all enrolled participants. The record does not report completion counts, missing-data methods or sensitivity analyses, leaving that possibility unassessed.
Finally, the registry identifies several secondary outcomes and reports selected safety counts, while listing no analyses. This underscores that endpoint definitions and adverse-event listings are not equivalent to statistical results. For biostatisticians and clinical researchers, the record is a useful example of how registry metadata can describe study intent while leaving the estimates, uncertainty, multiplicity handling and analysis populations unavailable for review.
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 numerical results for the primary PASI endpoint, including mean percentage change, standard deviation or confidence interval. It lists zero analyses. As a result, the primary outcome’s magnitude and precision cannot be evaluated. Numerical results for the named secondary outcomes are also not reported in the registry record.
The study has no described randomized comparator, and allocation is not stated. Participants were prescribed anti-TNF agents before enrollment, which means the record does not establish a controlled treatment contrast. It does not report individual agents, regimens, treatment duration, or how treatment selection was made beyond the stated national indications and reimbursement guidelines.
The primary population is defined by completing follow-up through Week 24, but the number meeting that definition is not reported. Counts available at each assessment, reasons for missing visits, discontinuations, missing-data methods and sensitivity analyses are also not reported in the registry record. The potential effect of incomplete follow-up therefore remains unclear.
The registry does not report the protocol, eligibility criteria in full, sample-size justification, statistical analysis plan, model assumptions, adjustment methods, or multiplicity strategy. The stated planning-illustration assumptions are not the same as the trial’s own design justification, which is not reported. Safety interpretation is limited by the absence of reported event attribution, timing, collection details and comparative data. Deaths are not reported in the registry record. These limitations prevent strong conclusions about efficacy, causality, precision or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis — NCT01126619.
- Registry record last updated 2012-10-25; status last verified 2012-10.
- Results first posted 2012-10-11.
- 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 study sponsored by Abbott, with enrollment of 103 participants and a focus on anti-TNF treatment in moderate to severe psoriasis. The recorded start was 2010-05, and primary completion was 2011-09. Participants were prescribed an anti-TNF agent before enrollment under national approved indications and reimbursement guidelines.
The primary outcome was percentage change from baseline in PASI score, assessed at Baseline and Weeks 4, 8, 16 and 24. The stated primary population comprised treated participants completing follow-up through Week 24. The registry also names secondary outcomes involving global assessments, quality of life, work productivity and adverse events.
For safety, the record lists 3 participants with serious adverse events and 7 with other adverse events, each among 103 at risk. Numerical PASI results, statistical analyses, missing-data methods and a randomized comparison are not reported in the registry record. The posted information therefore supports a description of study design and selected safety counts, but not a quantitative assessment of the primary outcome or a causal treatment effect.