Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) (NCT02092285), a na phase 4 study. The primary outcome is Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54.

2. Clinical Question

3. Trial Design

This was a phase 4, open-label, single-group study of golimumab in ulcerative colitis. It was conducted in the UK, enrolled 205 participants, and is listed as completed. The registry record gives a study start date of 2014-05-09 and a primary completion date of 2016-05-25.

Golimumab was the only intervention listed. The arm description says treatment began with subcutaneous induction doses at Day 0 and Week 2. Participants who responded at Week 6 received maintenance treatment. The maintenance-dose text ends partway through a dosing description, so the complete maintenance regimen is not reported in the registry record. No additional arm or placebo group is listed.

With one group and no masking, the study describes outcomes among participants receiving golimumab rather than estimating a randomized contrast between treatment strategies. Observations over time can describe the course of response in this group, but changes over time could also reflect factors other than treatment. There is no concurrent control group in this design to help distinguish those possibilities.

The primary outcome is a binary response measure: participants either meet or do not meet the stated clinical-response criteria at the required assessments. It concerns participants beginning treatment at baseline, response at Week 6, and continued response at both Week 30 and Week 54. The registry record identifies the Full Analysis Set for efficacy during maintenance as participants who received at least 1 dose of golimumab. It does not report further details of the statistical analysis or explain how incomplete follow-up was handled.

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: A total of 225 participants were screened; 205 participants started treatment after meeting eligibility criteria.

Induction Phase

Reasons for not completing this period:

Maintenance Phase & Follow-up

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analysis population for the evaluation of efficacy during the maintenance period was the Full Analysis Set (FAS205) consisting of participants who received at least 1 dose of golimumab.

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54, measured over Baseline (Week 0), Week 6, Week 30, Week 54.

The primary endpoint is the percentage of participants meeting the Partial Mayo Score response criteria through Week 54. The Partial Mayo Score excludes endoscopy and combines stool frequency, rectal bleeding, and physician’s global assessment. Each sub-score ranges from 0 to 3, with higher scores representing greater severity; the summed score ranges from 0 to 9.

Clinical response requires a reduction from baseline of at least 2 points and at least 30% in the Partial Mayo Score, together with either a reduction of at least 1 point in the rectal bleeding sub-score or an absolute rectal bleeding sub-score of no more than 1. The endpoint is more demanding than a response at a single visit: participants must meet the response definition by Week 6 and have positive responses at both Week 30 and Week 54.

A percentage is used to express the proportion of the defined population that meets this combined response condition. Requiring response at multiple visits describes sustained response among those assessed, rather than response at one isolated visit. The registry record lists Baseline (Week 0), Week 6, Week 30, and Week 54 as the timeframe. It does not report the percentage estimates or their confidence intervals, so the magnitude and precision of the observed endpoint cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a percentage endpoint describe?

A percentage expresses the share of a defined group that meets a specified condition. For this study, the condition is not just a change in score at one visit: it is response by Week 6 and positive clinical responses at both Week 30 and Week 54. The denominator and the handling of participants without all required measurements are therefore central to interpreting the percentage. The registry record identifies the efficacy population as the Full Analysis Set, consisting of participants who received at least 1 dose of golimumab, but does not give the number assessed at each visit or the detailed denominator rules used for the endpoint.

A percentage is a point estimate: it is the single best estimate of the proportion in the analyzed group based on the observed data. A confidence interval describes uncertainty around that estimate under the statistical model used. It is not a guarantee that the true value lies in the interval, nor does it address all sources of bias. In particular, an interval cannot correct for the absence of a control group or for unreported choices about missing data. The endpoint description specifies a 95% confidence interval, but its numerical limits are not reported in the registry record.

What does a single-group design allow?

In a single-group study, outcomes are observed among participants who receive the intervention, without a separate concurrent comparison group. Such data can describe what happened in the enrolled group and can estimate the proportion meeting a defined outcome if the results are reported. They do not directly estimate a treatment contrast against another group. Without random allocation to a comparator, differences between observed outcomes and an assumed alternative may reflect participant characteristics, changes over time, other care, or measurement as well as the intervention itself.

Open-label status means masking is listed as none. This is relevant to outcomes involving clinical assessment: knowledge of treatment can potentially influence assessment or reporting. The endpoint also includes a physician’s global assessment sub-score. The registry record does not describe any blinded assessment procedure, so the extent to which outcome assessment was protected from knowledge of treatment is not reported.

How should the response definition be read?

The Partial Mayo Score sums three sub-scores: stool frequency, rectal bleeding, and physician’s global assessment. Each sub-score ranges from 0 to 3, and the total ranges from 0 to 9, with higher scores indicating greater severity. The response rule requires a decrease of at least 2 points and at least 30% from baseline, plus either a decrease of at least 1 point in rectal bleeding or an absolute rectal bleeding sub-score of no more than 1. These conditions define who counts as a responder; they are not estimates of how many participants responded.

The sustained part of the endpoint requires response at Week 6 and positive responses at both Week 30 and Week 54. A participant with a response at one visit but without positive responses at all the required visits would not satisfy the described sustained endpoint. The registry record does not explain how an unavailable assessment at one of these visits is classified. That distinction can affect a percentage, especially when continued response is required across follow-up.

What can be inferred from the listed analysis information?

The record lists one outcome measure and no analysis entries. It does not report the statistical method used to calculate the endpoint estimate or confidence interval, any adjustment variables, or a detailed analysis plan. The absence of analysis entries in the registry record does not establish what analyses were or were not conducted outside the record; it means the analysis details cannot be evaluated from the posted information.

When interpreting a confidence interval, readers should consider both its width and the design that produced the estimate. A narrow interval can indicate greater statistical precision under the method’s assumptions, but it does not remove systematic limitations. A wide interval signals greater uncertainty about the proportion. Neither interpretation is possible for this primary endpoint without the actual estimate and interval limits.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. These are assumptions for a planning calculation, not evidence that the study itself used a two-arm design: the listed study is single group, with allocation not applicable.

Such planning calculations are conditional on the assumptions entered. They are not observed outcomes and are not “observed power.” The record does not report the study’s own sample-size justification or statistical plan, and the primary numerical result needed to interpret an observed effect is not reported. The planning assumptions therefore cannot substitute for the missing endpoint estimate or establish the precision of the study’s findings.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Golimumab")
n      <- c(205)
events <- c(51)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Golimumab  205  51  24.9  19.1  31.4  19.5  31.2  19.5  31.2

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure, assessed across Baseline (Week 0), Week 6, Week 30, and Week 54. The endpoint’s sustained-response definition specifically requires a Week 6 response and positive responses at both Week 30 and Week 54. Although several visits contribute to that single defined outcome, no multiplicity strategy or adjustment is reported in the registry record. The record also does not describe any additional confirmatory comparisons or a broader testing hierarchy.

Missing-data handling is not reported in the registry record. In particular, it does not state how participants without a Week 6, Week 30, or Week 54 assessment were treated, or whether an unavailable visit counted as failure to meet the sustained-response endpoint. It also does not describe methods for handling treatment discontinuation or other departures from follow-up. These choices can affect both the numerator and denominator of a percentage endpoint and therefore matter for interpretation.

The stated efficacy population is the Full Analysis Set, defined as participants who received at least 1 dose of golimumab. The registry record does not provide a visit-specific accounting of participants in that population or explain whether all were included in the primary endpoint calculation. The enrollment was 205, but the number with evaluable primary-outcome data is not reported in the registry record. No analysis entries are listed, so details about analysis populations and missing-data methods cannot be checked against a reported analysis.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: colitis ulcerative (11.2%), colitis (2.4%), accidental overdose (1.5%), pulmonary embolism (1.0%), bradycardia (0.5%).

The safety record lists 205 participants at risk for serious adverse events and 49 affected. For other adverse events, it lists 205 at risk and 82 affected. These are separate categories in the posted safety information; the figures should not be added together, and the record does not state whether the participants affected in the two categories overlap. The number of deaths is not reported in the registry record.

The listed serious-event terms and percentages are COLITIS ULCERATIVE, 11.2%; COLITIS, 2.4%; ACCIDENTAL OVERDOSE, 1.5%; PULMONARY EMBOLISM, 1.0%; BRADYCARDIA, 0.5%; and MYOCARDIAL INFARCTION, 0.5%. These terms describe the recorded event categories and do not, on their own, establish that golimumab caused an event. The registry record does not give further details about event onset, duration, severity beyond the serious classification, or attribution.

Safety counts should be interpreted in the context of the single treated group. Without a comparator, the record cannot show how these counts compare with an alternative treatment group. The listed figures describe reported events in this study; they are not a controlled estimate of comparative risk.

13. What the Result Does, and Does Not, Mean

This study addresses a clear longitudinal question: whether participants starting golimumab met a defined clinical-response threshold by Week 6 and maintained response at Week 30 and Week 54. The use of a specified score and explicit response criteria gives the endpoint a recognizable operational definition. The record also identifies the population intended for efficacy evaluation and lists safety-event counts for the treated group.

At the same time, the numerical primary result is not reported in the registry record. The endpoint description alone cannot establish the percentage meeting the criteria, the confidence interval around that percentage, or how many participants contributed data at each assessment. The posted information therefore does not permit a quantitative account of the primary outcome’s magnitude or precision.

The study is open label and single group, with no separate comparator. As a result, even a reported response proportion would describe the treated participants rather than provide a randomized estimate of the difference between golimumab and another strategy. Outcomes may change over time for reasons that a single-group design cannot separate from treatment. The physician’s global assessment component also makes the open-label context relevant to interpreting the score.

The record does not report missing-data methods, the analysis plan, or a study-specific sample-size justification. These omissions limit evaluation of how the endpoint was analyzed and how uncertainty was handled. The safety counts are descriptive and likewise lack a concurrent control group for comparison.

Accordingly, the registry record supports understanding what the investigators intended to measure and the broad design in which it was measured. It does not support a conclusion about the observed primary response rate, comparative effects, or causal attribution of safety events. Those questions require numerical results and analytic details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of a longitudinal endpoint built from a clinical score and repeated response assessments. The endpoint does not count a transient response at a single visit; its definition requires response by Week 6 and continued positive responses at Week 30 and Week 54. That makes the interpretation depend on both the response threshold and the availability of follow-up measurements.

The case also illustrates why a clearly defined outcome is not enough to evaluate evidence. The registry record specifies the Partial Mayo Score components, score ranges, response rule, follow-up times, and an efficacy population. Yet the primary percentage and its 95% confidence interval are not reported. Without those quantities, readers cannot evaluate the observed frequency of sustained response or its statistical precision.

The study’s single-group, open-label structure is another important statistical feature. Descriptive outcomes in treated participants can be useful for characterizing what was observed in that group, but they do not provide the same evidence as a randomized comparison. The absence of a concurrent comparator makes causal interpretation and comparative-effect estimation unavailable from this design.

Finally, the record illustrates the importance of reporting analysis populations and missing-data decisions for outcomes requiring multiple visits. The Full Analysis Set is defined, but visit-level data handling is not described. Together, the missing primary estimate and missing analytic details limit the scope of conclusions that can be drawn from the posted record.

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 main trial-specific limitation for interpreting the primary endpoint is that its numerical result is not reported in the registry record. The record names the measure and specifies a 95% confidence interval, but neither the percentage nor the interval limits are available. Counts meeting the endpoint and the number assessed at the required visits are also not reported.

The single-group design has no concurrent control arm, and masking is listed as none. Thus, the record cannot support a randomized comparison or distinguish treatment-associated change from other influences over time. Because the response measure includes a physician’s global assessment, the open-label design is relevant to how the outcome may be assessed, although the record does not describe assessment procedures in detail.

The registry record does not report how missing follow-up assessments were handled, whether unavailable visits counted as nonresponse, or how discontinuation affected the analysis. These details are particularly relevant to an endpoint that requires positive responses at multiple visits. The Full Analysis Set is defined as participants who received at least 1 dose, but visit-specific analysis numbers are not reported.

The arm description’s maintenance-dose text is incomplete, so the full regimen cannot be established from the registry record. The record also does not report the study’s own sample-size justification, statistical plan, or multiplicity approach. No analysis entries are listed. These reporting gaps limit evaluation of the analysis and of the precision the study was designed to achieve.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) — NCT02092285.
• Registry record last updated 2019-03-15; status last verified 2019-02.
• Results first posted 2017-10-13.
• 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.

19. Record Summary

NCT02092285 is a completed phase 4, UK, open-label, single-group study of golimumab in ulcerative colitis. The study enrolled 205 participants. Its primary outcome is the percentage meeting Partial Mayo Score clinical-response criteria by Week 6 and maintaining positive responses at both Week 30 and Week 54.

The record defines the score, response rule, assessment times, and efficacy population. It does not report the numerical primary outcome or confidence interval, and no analysis entries are listed. Safety information records 49 affected participants among 205 at risk for serious adverse events and 82 among 205 at risk for other adverse events. A separate comparator group is not listed.