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 Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). (NCT02318667), a na phase 4 study. The primary outcome is Serum ST2 Level at Week 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02318667 |
| Phase | Phase 4 |
| Condition | Colitis, Ulcerative |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with moderate to severe ulcerative colitis who had failed prior conventional therapies. The primary endpoint population is described as participants with available Week 6 ST2 data; the registry record does not report how many had those data.
Intervention
Golimumab treatment in an open-label study. The listed schedule begins with 200 mg by subcutaneous injection at Week 0, then 100 mg at Week 2, followed by 50 mg or 100 mg every 4 weeks up to 16 weeks, per prescribing information.
Comparator
There is no separate comparison group. The study is single-group, with no masking and no randomized allocation. Comparisons described in the secondary outcomes concern participant subgroups or measurements over time, not a like-for-like control arm.
Primary question
The primary endpoint is serum ST2 level at Week 6, measured in ng/mL and described as a mean with standard deviation. The broader study question is whether serum soluble ST2 is associated with endoscopic or histological disease activity, or clinical response, during golimumab treatment. The registry record does not report the Week 6 ST2 result or a correlation estimate.
ST2 is described in the record as a serum biomarker and as the receptor for Interleukin-33, within the Interleukin-1 receptor superfamily. The study was designed to examine its relationship to disease measures in participants with moderate to severe ulcerative colitis. Planned assessments included endoscopic activity using the Mayo endoscopic subscore, histological activity using the Geboes index, and clinical activity using the total Mayo score. Other listed assessments involve faecal calprotectin and the Ulcerative Colitis Endoscopic Index of Severity.
These questions are about biomarker levels and their association with disease assessments. They are not, by themselves, evidence that ST2 predicts an individual participant’s future outcome or that a biomarker-guided decision improves care. The record does not report results that would establish either conclusion.
3. Trial Design
This was a Phase 4, open-label, single-group assignment study of golimumab in moderate to severe ulcerative colitis. The registry lists enrollment of 38 participants and marks the study as completed. Its start date is 2015-02-27 and its primary completion date is 2017-06-21. There was no masking and no randomized allocation; the record identifies no separate control group.
Participants received golimumab according to the listed schedule: 200 mg by subcutaneous injection at Week 0, 100 mg at Week 2, then 50 mg or 100 mg every 4 weeks up to 16 weeks, per prescribing information. The record does not report how the choice between the two later doses was made, so that choice should not be inferred from the schedule.
The primary outcome is serum ST2 level at Week 6, expressed in ng/mL and characterized by a mean and standard deviation. The primary population is described as participants with available Week 6 ST2 data. The study description says the biomarker was to be examined in relation to endoscopic or histological activity and clinical response. Secondary outcomes include ST2 at Week 16; correlations with endoscopic, histological, clinical, and faecal calprotectin measures; changes in ST2 between baseline and Week 6; and an association between Mayo endoscopic subscore and UCEIS overall score.
Because all participants received the study treatment and the design has no control arm, changes over time or relationships between measurements cannot isolate a treatment effect from other explanations. The registry record does not report the protocol’s allocation rationale, a statistical analysis plan, sample-size justification, or interim-analysis plan. Any planning illustrations based on an observed effect are not a description of the trial’s design or evidence of observed power.
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 | Golimumab Treatment |
|---|---|
| STARTED | 38 |
| COMPLETED | 29 |
| NOT COMPLETED | 9 |
Reasons for not completing this period:
| Reason | Golimumab Treatment |
|---|---|
| Adverse Event | 1 |
| Lack of Efficacy | 6 |
| Protocol Violation | 2 |
Analysis population for the primary outcome, as defined in the registry: Participants with available Week 6 ST2 data.
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 | Golimumab Treatment |
|---|---|---|
| Participants analysed | 38 | |
| Age, Continuous | Years | 34.8 (SD 12.15) |
| Sex: Female, Male: Female | Participants | 23 |
| Sex: Female, Male: Male | Participants | 15 |
| Race and Ethnicity Not Collected | Participants | — |
| Serum human Suppression of Tumorigenicity 2 (ST2) level | ng/mL | 21.8 (SD 11.09) |
6. Primary Endpoint
The registry lists the primary outcome as Serum ST2 Level at Week 6, measured over Week 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is serum ST2 level at Week 6, measured in ng/mL. The record identifies the measure as continuous and specifies a mean and standard deviation as its summary form. It also states that Week 6 ST2 data were collected to assess whether ST2 correlated with endoscopic or histological activity, or clinical response, in participants with moderate to severe ulcerative colitis.
A continuous biomarker measurement can preserve differences across a range of values, rather than reducing the result to categories. A mean describes the average observed level in the analyzed group; a standard deviation describes the spread of individual measurements around that mean. These summaries do not, on their own, show whether ST2 is associated with disease activity. Assessing an association requires paired ST2 and disease-assessment data and a specified analysis.
The endpoint description gives the measurement and time point, but the registry record does not report the Week 6 mean, standard deviation, number with available measurements, or a correlation estimate. It also does not report the particular statistical method used to evaluate associations. Consequently, the endpoint definition alone does not establish the direction, strength, or precision of any relationship between ST2 and disease activity.
In general, a biomarker’s association with a clinical measure is distinct from its usefulness as a surrogate for clinical benefit. The record’s proposed role for ST2 is to evaluate it as a biological marker related to disease outcome and treatment response; the reported endpoint description does not establish surrogate validity.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a study intended to characterize serum ST2 and its relationships with measures of ulcerative colitis activity during golimumab treatment. It identifies the primary measurement and several related secondary assessments, but does not report their numerical results. In particular, the Week 6 ST2 mean and standard deviation, the number of participants contributing to that endpoint, and the planned or observed association estimates are not reported in the registry record.
This distinction matters: an endpoint’s definition is not its result. Knowing that ST2 was measured at Week 6 does not show whether values were high or low, how variable they were, or whether they tracked endoscopic, histological, or clinical activity. Without estimates and their uncertainty, the strength and precision of any observed association cannot be assessed. The registry record also does not report confidence intervals or p-values for these questions.
The design further limits what any within-group association could establish. Everyone in the study received golimumab, and there was no randomized comparator. A relationship between biomarker level and an activity measure would describe co-variation in the observed participants; it would not, by itself, demonstrate that golimumab caused the biomarker pattern or that ST2 caused a change in disease activity. Nor would it establish that ST2 can predict response for participants outside the study.
The registry lists secondary outcomes at different times, including assessments at baseline, Week 6, and Week 16. Repeated measurements can help describe how a biomarker and disease measures change together over time, but interpretation depends on who contributed measurements at each time and how missing observations were handled. Those details and the analysis results are not reported in the registry record.
General statistical interpretation should distinguish an estimate from its precision. A confidence interval, when reported, describes a range of values compatible with the data and analysis under its assumptions; a narrow interval indicates greater precision than a wide one. No interval for the primary endpoint or its associations is reported in the registry record, so precision cannot be judged from this entry.
The safety figures are separate from the biomarker question. The registry reports serious adverse events affecting 4 participants among 38 at risk, other adverse events affecting 4 among 38 at risk, and 0 deaths. It also lists colitis ulcerative and pneumonia among serious-event terms. These entries describe reported events in this treated group; without a control group, they do not establish how event rates compare with another treatment or what caused any event.
Overall, the record supports a description of the study’s design, endpoints, treatment schedule, and selected safety entries. It does not provide enough outcome information to judge the observed ST2 level, its relationship to disease activity, or the precision of those relationships. The absence of results from this registry entry should not be read as evidence that an association was absent.
9. Statistical Methods Explained
The registry identifies the primary measure as a continuous outcome: serum ST2 level at Week 6, in ng/mL, summarized using a mean and standard deviation. It does not report the analysis used for this endpoint or the analyses used for the listed correlations. The explanations below describe general statistical concepts, not methods confirmed as having been used in this study.
What does a mean and standard deviation describe?
In general, the mean is an average that summarizes the center of a set of measurements. The standard deviation describes how dispersed those measurements are around the mean. Neither statistic describes the full distribution, and both can be influenced by extreme values. For a biomarker, it can be useful to examine the distribution and individual observations as well as the mean and standard deviation, particularly if values are skewed. The registry record does not report distributional checks, transformations, or alternative summaries for ST2.
What does a correlation measure?
In general, correlation quantifies how two measurements vary together. A positive association means higher values of one measure tend to occur with higher values of the other; a negative association means higher values tend to occur with lower values. The size of a correlation describes the strength of a particular form of association, not causation. Different correlation methods make different assumptions: a Pearson correlation characterizes linear association and can be sensitive to outliers, while rank-based methods characterize a monotonic relationship using ranks. The registry record names correlation questions but does not report which method was selected, its assumptions, or any correlation estimates.
Association estimates are also affected by measurement quality and the range of values in the study population. If a measure has restricted variation, an association can appear weaker than it would in a more varied population. Measurement error can also blur relationships. These are general considerations; the registry record does not report the observed ranges, reliability assessments, or diagnostic analyses for ST2 or the disease measures.
Why does dispersion matter?
In general, over-dispersion means that observed variability is greater than a statistical model expects. A model that understates variability can yield uncertainty estimates that are too small, making results appear more precise than they are. Conversely, a model that does not reflect the data’s distribution can provide a poor summary. The registry record does not report whether over-dispersion was assessed or whether a model-based analysis was used.
How should uncertainty be read?
A confidence interval is a general way to express uncertainty around an estimate. It gives a range of values that are reasonably compatible with the observed data under the specified method and assumptions. Its width reflects precision: wider intervals indicate more uncertainty. A p-value, in general, describes how unusual data at least as extreme as those observed would be under a specified null model; it is not the probability that the null hypothesis is true, nor a measure of clinical importance. The registry record does not report confidence intervals or p-values for the primary ST2 measure or the biomarker correlations.
There is no single interpretation of a result without considering its scale and context. For a correlation, the estimate’s direction and magnitude matter, as does its uncertainty. A small p-value alone would not establish that the association is meaningful or useful for prediction. The record does not report a prespecified threshold for an important association or any validation analysis.
What can repeated measurements add?
The listed outcomes include measurements at more than one time point. In general, repeated measurements can show whether values change over time and whether two measures move together. However, observations from the same participant are related; treating them as independent can understate uncertainty. Methods for repeated measurements account for this dependence in different ways. The registry record does not report whether a repeated-measures model, a paired analysis, or another approach was used. It also does not report how participants with incomplete follow-up were handled.
What do planning illustrations mean?
A sample-size calculation is a planning exercise: it estimates how many participants might be needed to detect a specified effect under stated assumptions. The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. These are planning assumptions, not the design of this single-group study. Such calculations do not measure observed power and do not establish that a result is statistically significant. The registry record does not report a trial-specific sample-size justification.
The statistical analysis plan, exact correlation methods, model specifications, handling of outliers, and uncertainty procedures are not reported in the registry record. Therefore, general method descriptions should not be mistaken for a reconstruction of the analyses actually performed.
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 |
|---|---|---|---|---|
| Golimumab Treatment | 34 | 21.800 | 14.410 | 16.772 to 26.828 |
R code and output
arm <- c("Golimumab Treatment")
n <- c(34)
m <- c(21.8)
sp <- c(14.41)
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 Golimumab Treatment 34 21.800 14.410 16.772 26.82811. Multiplicity, Missing Data and Analysis Populations
The record lists 11 outcome measures and 2 analyses, including the primary Week 6 ST2 level and several secondary outcomes involving ST2, disease activity, faecal calprotectin, and endoscopic measures at different time points. It does not explain how those analyses relate to the outcome measures, which comparisons were designated as primary within each analysis, or whether any outcomes were exploratory.
When several hypotheses are tested, the chance of at least one apparently notable finding can increase. In general, multiplicity procedures can adjust interpretation or testing to account for multiple comparisons. The registry record does not report whether multiplicity was considered, whether tests were adjusted, or how the findings were prioritized. No particular correction method should be inferred.
The primary endpoint population is described as participants with available Week 6 ST2 data. The record does not report how many participants had those data, whether participants without Week 6 data differed from those with data, or how missing values were handled. It also does not report analysis populations for the secondary outcomes, rules for including measurements, or whether any imputation was used.
Missing data can affect both the estimate and its precision. In general, complete-case analyses describe participants with observed data, and may be biased if missingness is related to a participant’s characteristics or outcome. Imputation methods make additional assumptions and do not remove uncertainty about missing values. Without details on missingness and analysis populations, the degree to which incomplete data could influence results cannot be assessed.
The statistical plan, handling of multiple outcomes, and missing-data strategy are not reported in the registry record. The listed endpoint definitions should therefore not be taken as evidence that these issues were resolved in a particular way.
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 |
|---|---|---|---|
| Golimumab Treatment | 4 | 38 | 10.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Golimumab Treatment | 0 of 38 |
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 |
|---|---|
| Golimumab Treatment | 4 of 38 |
Most frequent serious adverse event terms
| Event term | Organ system | Golimumab Treatment |
|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | 3 of 38 |
| Pneumonia | Infections and infestations | 1 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Golimumab Treatment |
|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | 4 of 38 |
Serious events with the highest arm-level rate: colitis ulcerative (7.9%), pneumonia (2.6%).
The registry reports 38 participants at risk for serious adverse events and 4 affected. It separately reports 38 at risk for other adverse events and 4 affected. These are separate entries; the record does not establish whether the same participants contributed to both categories. Deaths are reported as 0.
The listed serious-event terms include colitis ulcerative at 7.9% and pneumonia at 2.6%. These percentages are reproduced as reported; the record does not provide additional detail in this entry about event timing, recurrence, severity grading, or the basis for the percentages. The event terms should not be interpreted as proof that golimumab caused them. The record is a single-group study, so these figures do not provide a like-for-like comparison with an untreated group or another treatment.
In general, adverse-event summaries describe events observed and recorded during a study; they do not by themselves determine causality. Interpretation also depends on definitions, observation time, completeness of reporting, and the characteristics of participants. The registry record does not report the detailed methods needed to assess those factors. The safety entries should be read as descriptive figures for the study group, not as comparative estimates.
13. What the Result Does, and Does Not, Mean
The study addresses a relevant measurement question: whether serum soluble ST2 is associated with endoscopic, histological, or clinical assessments in participants with moderate to severe ulcerative colitis receiving golimumab. Its primary endpoint is clearly identified as Week 6 serum ST2 level, and its secondary outcomes extend the planned inquiry to other disease measures and time points.
What the record does not establish is the result of that inquiry. It does not report a Week 6 ST2 mean or standard deviation, a correlation estimate, a confidence interval, or a p-value. It therefore cannot show the direction or size of an association, nor how precisely it was estimated. A missing result in the registry entry is not equivalent to a finding of no association.
Even if an association were observed, correlation alone would not show that ST2 causes disease activity or that treatment caused the association. The single-group, open-label design has no randomized control group to separate treatment-related changes from other influences. An association within the study group would also not, by itself, demonstrate that ST2 reliably predicts an individual participant’s future outcome.
In general, a surrogate biomarker is intended to stand in for an outcome of greater clinical relevance. Showing that a biomarker correlates with a disease measure is only one part of that evaluation. Establishing a useful surrogate requires evidence that goes beyond a single association, including evidence that the biomarker reflects meaningful outcomes in relevant settings. The registry record does not report such validation.
The safety entries provide descriptive information about reported events and deaths in the treated group, but not a comparison with another treatment. The record’s design and reported results therefore support an account of what was planned and some safety counts, not a conclusion about comparative safety or treatment benefit.
14. Why This Trial Matters Statistically
This trial is statistically notable for its focus on a biomarker question in a defined clinical setting: moderate to severe ulcerative colitis among participants who had failed prior conventional therapies. It links a continuous serum measurement to endoscopic, histological, and clinical assessments. Such questions require attention both to how each measure is summarized and to how the association between measures is estimated.
The study also illustrates the difference between a single-group biomarker study and a controlled treatment comparison. A single group can describe measurements during treatment and explore whether they vary together. Without a control arm, however, changes cannot be separated from time trends, natural variation, or other factors. No randomized allocation or masking is reported, which also means the design does not provide a blinded comparison.
The listed assessments span several measures and time points. This creates statistical questions about repeated observations, missing data, and multiple analyses. The registry record does not report how these issues were handled. Those details matter because they affect the uncertainty and interpretation of associations, not just the choice of a summary statistic.
The record further shows why endpoint definitions and results should be distinguished. It specifies the Week 6 measurement and the population with available data, but does not provide the result or its precision. For statistical interpretation, a clear endpoint is necessary but insufficient: readers also need estimates, uncertainty, analysis methods, and information about who contributed data.
Finally, an association between a biomarker and disease activity is not equivalent to validation of a surrogate endpoint. The study’s stated aim makes ST2 a candidate marker of interest, but the registry record does not report evidence establishing predictive performance or clinical utility. These distinctions are central when moving from exploratory biomarker associations to claims about prediction or treatment effects.
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 most direct limitation for interpreting the statistical question is that the registry record does not report results for the primary endpoint. It gives no Week 6 ST2 mean, standard deviation, analysis population count, or estimate of association with the disease measures. The secondary outcome results are also not reported in this entry, so the planned relationships cannot be evaluated from it.
The design is single-group and open-label, with no randomized allocation or separate control group. As a result, it cannot provide a like-for-like comparison that separates outcomes during golimumab treatment from outcomes under another condition. The record’s enrollment of 38 participants also defines the study’s scope, but the number contributing to each endpoint is not reported.
The population for the primary outcome is limited to participants with available Week 6 ST2 data. The record does not report the extent or pattern of missing data, or the approach used to handle incomplete measurements. If availability is related to participant status or outcome, estimates based only on observed data could differ from those that would have been obtained with complete follow-up.
Several outcome measures and time points are listed, but the statistical plan and approach to multiplicity are not reported. The correlation method, model assumptions, and uncertainty estimates are also not reported. Without these details, it is not possible to assess how analysis choices might affect results or whether exploratory and confirmatory questions were distinguished.
Finally, the stated goal includes evaluating ST2 as a biomarker related to outcome and response, but this record does not report predictive performance or validation. An observed association, if available, would not alone establish that ST2 is a valid surrogate or that it can predict outcomes beyond the study group.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). — NCT02318667.
- Registry record last updated 2021-01-27; status last verified 2021-01.
- Results first posted 2018-08-20.
- 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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19. Record Summary
This completed Phase 4 study examined serum soluble ST2 in participants with moderate to severe ulcerative colitis receiving golimumab. It was open-label, used a single-group design, had no masking or randomized allocation, and lists enrollment of 38 participants.
The primary endpoint was serum ST2 level at Week 6, measured in ng/mL and summarized by mean and standard deviation among participants with available data. Listed secondary outcomes include relationships with endoscopic, histological, clinical, and faecal calprotectin measures, as well as assessments at multiple time points. The registry record does not report the primary endpoint result, the association estimates, or the statistical analysis plan.
For safety, the record reports 4 participants affected among 38 at risk for serious adverse events, 4 affected among 38 at risk for other adverse events, and 0 deaths. Colitis ulcerative and pneumonia are listed among serious-event terms. These are descriptive entries from a single-group study and do not provide comparative safety estimates.