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 Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo (NCT02092389), a registered phase not stated study. The primary outcome is Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02092389 |
| Phase | Phase not stated |
| Condition | Moderate to Severe Ulcerative Colitis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AbbVie |
| Results posted | Yes |
2. Clinical Question
Population
Patients with moderate to severe ulcerative colitis who had not responded despite an adequate course of corticosteroid and immunosuppressant therapy, or who were intolerant to or had medical contraindications for such therapy. The registry record lists enrollment of 10 participants.
Intervention
Adalimumab therapy. The study sought to follow fecal calprotectin levels and their relationship to participants’ general wellbeing, workability, and disease activity while receiving this therapy.
Comparator
No randomized comparator is described. The registry record does not state an allocation method, and the available study description is not a like-for-like controlled comparison. The results therefore cannot establish a treatment contrast against another therapy or a control condition.
Primary question
Among enrolled participants with fecal calprotectin data at Month 12 when the study ended, what percentage had a level ≤ 150 µg/g? The registry also lists questions about changes in workability, quality of life, and disease activity, and correlations between those measures and fecal calprotectin. It reports no meaningful primary analysis.
3. Trial Design
AdaProQuo was a study of adalimumab therapy in patients with moderate to severe ulcerative colitis. Eligibility descriptions refer to patients who had not responded despite a full and adequate course of corticosteroid and immunosuppressant therapy, or who were intolerant to or had medical contraindications for such therapy. The listed enrollment was 10. The registry does not describe a randomized comparison or a control group; allocation is not stated, and the study should not be read as a like-for-like comparison between treatments.
The study objectives were to explore fecal calprotectin levels during therapy and their association with general wellbeing, workability, and disease activity. The primary endpoint was the percentage of participants with fecal calprotectin at or below 150 µg/g after 12 months of treatment. Secondary outcomes included changes from baseline to Month 12 in workability, quality of life, and disease activity, together with correlations between fecal calprotectin and each of those measures. The registry lists 7 outcome measures in total.
The study started in 2014-07, and primary completion was recorded as 2015-10. Its status is TERMINATED. The registry states that termination was due to low enrollment. It also says that data for participants with available Month 12 fecal calprotectin measurements at termination are provided, while noting that no meaningful analysis can be presented. A detailed protocol, a rationale for the enrollment target, and the planned statistical analysis are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Moderate to Severe Ulcerative Colitis |
|---|---|
| STARTED | 10 |
| COMPLETED | 4 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Moderate to Severe Ulcerative Colitis |
|---|---|
| Adverse Event | 1 |
| Other | 5 |
Analysis population for the primary outcome, as defined in the registry: Enrolled participants with Month 12 data at the time of study termination
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: All enrolled participants with demographic and baseline data available.
| Characteristic | Unit | Moderate to Severe Ulcerative Colitis |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 51.8 (SD 16.88) |
| Gender: Female | Participants | 4 |
| Gender: Male | Participants | 6 |
| Fecal calprotectin (fC) levels at baseline | μg/g | 440 (SD 393.6) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab, measured over Month 12.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants whose fecal calprotectin level was ≤ 150 µg/g after 12 months of adalimumab treatment. The registry defines the relevant population as enrolled participants who had Month 12 data at the time of study termination. This is a threshold-based endpoint: it classifies an available measurement according to whether it is at or below the stated cut-off, rather than describing the size of each participant’s change from baseline.
The registry describes fecal calprotectin as a non-invasive surrogate marker of inflammation in the small intestine and states that levels below 250 ug/g are associated with mucosal healing. The study’s endpoint uses a different stated threshold, ≤ 150 µg/g. The reason for selecting that endpoint threshold and its relationship to the registry’s marker description are not reported in the registry record. Fecal calprotectin was measured using enzyme-linked immunosorbent assay and/or a validated quantitative rapid test.
A percentage based on a threshold can provide a compact account of how many participants with measurements met the endpoint definition. It does not, by itself, describe individual trajectories, explain why measurements were unavailable, or establish a treatment effect. The numerical primary-endpoint estimate is not reported in the registry record, and the record says no meaningful analysis can be presented.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that AdaProQuo was terminated because of low enrollment. Although the registry lists enrollment of 10, it explicitly states that no meaningful analysis can be presented for the primary endpoint. It describes available Month 12 fecal calprotectin data at termination, but a numerical estimate of the percentage meeting the ≤ 150 µg/g threshold is not reported in the registry record. The treatment outcome therefore cannot be quantified from the reported primary result.
The registry lists seven outcome measures, including the primary fecal calprotectin threshold and secondary measures of workability, quality of life, disease activity, and correlations among these measures. It reports zero analyses. Numerical estimates, uncertainty intervals, and statistical tests for these outcomes are not reported in the registry record. The stated objectives should therefore be understood as questions the study intended to explore, not as findings that the registry demonstrates.
The design also limits what any observed values could establish. The record does not describe a randomized comparator, and allocation is not stated. Without a like-for-like control comparison, changes during treatment cannot be separated from other explanations using a treatment contrast. Correlations, even if estimates had been reported, would describe how measurements vary together; they would not show that one measure caused a change in another.
The registry’s endpoint population is restricted to enrolled participants with Month 12 data available at termination. The number of participants with such data is not reported in the registry record. As a result, the size and representativeness of the endpoint population cannot be assessed from the available description. The record also does not describe how unavailable measurements were handled or whether any analysis population beyond the endpoint definition was used.
The safety information is descriptive and comes from a small enrolled group. The registry reports 2 participants with serious adverse events among 10 at risk, with “No therapeutic response” listed at 20.0% among the top serious terms. It reports 0 participants with other adverse events among 10 at risk. These figures do not establish whether an event was caused by adalimumab, and the death value is not reported in the registry record. Overall, the posted information is too limited to support a reliable estimate of the primary endpoint or a comparative conclusion.
9. Statistical Methods Explained
Statistical methods help define what a study estimate means, how much uncertainty surrounds it, and which participants contributed to it. In AdaProQuo, the registry lists outcome definitions and a primary analysis population but reports no meaningful primary analysis and no analyses. Consequently, general statistical concepts can clarify how the planned measures would ordinarily be interpreted, but they cannot supply missing estimates for this study.
What does a threshold percentage represent?
For a binary threshold endpoint, each participant with an available measurement is classified according to whether the measurement meets the stated criterion. The percentage is the proportion of the defined analysis population classified as meeting that criterion. AdaProQuo set the criterion at fecal calprotectin ≤ 150 µg/g at Month 12, and defined the population as enrolled participants with Month 12 data at termination. The count and percentage meeting that criterion are not reported in the registry record. Without them, neither the observed endpoint level nor its precision can be assessed.
In general, a percentage is easier to interpret when its denominator is clear. A percentage calculated among participants with measurements answers a question about that observed subset; it does not automatically describe everyone enrolled. If participants without measurements differ from those with measurements, the observed subset may not represent the full enrolled group. The registry does not report the number with Month 12 data or a method for addressing missing measurements.
What would an uncertainty interval add?
In general, a confidence interval gives a range of estimates compatible with the observed data under the method used. It conveys precision as well as the point estimate: a broader interval indicates greater uncertainty about the underlying value. A confidence interval is not a guarantee that the true value lies within its limits, nor does it correct for bias from missing data or study design. No interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated.
A small enrolled group generally yields limited information, particularly when only a subset has measurements for a particular endpoint. The registry gives enrollment of 10 but does not state how many participants contributed Month 12 data. It is therefore not possible to determine the endpoint denominator or to characterize the precision of a hypothetical estimate from the record.
How should the correlation objectives be understood?
The listed secondary objectives include correlations between fecal calprotectin and disease activity measured by the Partial Mayo Score, quality of life measured by the sIBDQ, and workability measured by the WPAI:UC questionnaire. In general, a correlation describes the direction and strength of an association between measurements. It does not establish that changes in one measure cause changes in another. Estimates can also be sensitive to the range of measurements and the number of observed participants. Correlation estimates and methods are not reported in the registry record.
The registry also lists change from baseline to Month 12 for workability, quality of life, and disease activity. In general, a change score describes the difference between measurements at two times for participants with data at both times. Its interpretation depends on the outcome scale, the available observations, and the analysis method. The registry does not report numerical changes, uncertainty estimates, or details of how incomplete paired measurements were handled.
What do the planning assumptions mean?
The stated sample-size illustrations are planning calculations based on an observed effect, not the trial’s own design and not observed power. The assumptions specified are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. In general, such calculations illustrate the sample size that might be needed under chosen assumptions. They do not show the probability that a completed study detected an effect, and they do not turn a non-randomized study into a controlled comparison.
These assumptions should be distinguished from the registry’s study description. The record does not describe a randomized comparison, and allocation is not stated. It also does not report the study’s own sample-size justification. A planning illustration using two-arm assumptions is therefore not evidence that AdaProQuo had two comparable treatment groups or was designed with that allocation.
More broadly, an analysis plan would ordinarily clarify the target population, endpoint calculation, uncertainty estimation, handling of missing outcomes, and interpretation of multiple outcomes. Those details are not reported in the registry record. The absence of those details, combined with the stated lack of meaningful analysis, means the listed objectives cannot be treated as completed statistical 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.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Moderate to Severe Ulcerative Colitis | 2 | 2 | 100.0% | 15.8% to 100.0% | 34.2% to 100.0% | 29.2% to 99.2% |
R code and output
arm <- c("Moderate to Severe Ulcerative Colitis")
n <- c(2)
events <- c(2)
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 Moderate to Severe Ulcerative Colitis 2 2 100.0 15.8 100.0 34.2 100.0 29.2 99.211. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary fecal calprotectin threshold and secondary outcomes covering workability, quality of life, disease activity, and correlations between these measures. Examining several outcomes raises a general multiplicity issue: when many statistical tests are performed, the chance of at least one apparently notable result can increase. In general, a statistical analysis plan may specify which outcomes are primary, whether tests are confirmatory or exploratory, and how multiplicity is handled. A multiplicity adjustment or other strategy is not reported in the registry record.
The record reports zero analyses and says that no meaningful analysis can be presented. It therefore provides no outcome estimates or tests to interpret in light of multiplicity. The absence of reported tests should not be mistaken for evidence that the outcomes were equivalent or that no associations existed.
For the primary endpoint, the registry defines the population as enrolled participants with Month 12 fecal calprotectin data available at termination. The count in this population is not reported in the registry record. The record does not explain the extent or reasons for unavailable data, how missing measurements were handled, or whether participants without Month 12 data were included in any other analysis. A complete-case endpoint percentage, if calculated, would describe only those with data unless additional methods were used; no such methods are reported.
The analysis populations for secondary outcomes are not reported in the registry record. The registry does not state whether baseline and follow-up data were required for change outcomes, how missing questionnaire responses were treated, or how incomplete data affected correlation analyses. These gaps make it impossible to assess the influence of missingness or determine whether the analyzed participants differed from all enrolled participants.
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 |
|---|---|---|---|
| Moderate to Severe Ulcerative Colitis | 2 | 10 | 20.0% |
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 |
|---|---|
| Moderate to Severe Ulcerative Colitis | 0 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Moderate to Severe Ulcerative Colitis |
|---|---|---|
| No therapeutic response | General disorders | 2 of 10 |
Serious events with the highest arm-level rate: no therapeutic response (20.0%).
The registry reports safety counts for the group labeled “Moderate to Severe Ulcerative Colitis.” For serious adverse events, 10 participants were at risk and 2 were affected. “No therapeutic response” is listed among the top serious terms at 20.0%. For other adverse events, 10 participants were at risk and 0 were affected. The number of deaths is not reported in the registry record.
These figures are counts in a small enrolled group, not a comparative estimate against another treatment or a control group. They describe what the registry records for the study group; they do not establish whether an event was caused by adalimumab. The “No therapeutic response” term is reported as a serious term, but the registry information does not provide further context for its classification or individual circumstances.
The death entry should not be interpreted as zero deaths: its value is not reported in the registry record. More generally, counts without comparative data cannot establish relative safety, and a lack of a recorded event in this group does not show that the event cannot occur. The registry does not report additional details needed to assess event timing, duration, or relatedness.
13. What the Result Does, and Does Not, Mean
The record establishes that AdaProQuo was an investigation of fecal calprotectin and related patient-reported and disease-activity measures during adalimumab therapy in moderate to severe ulcerative colitis. It defines a primary endpoint based on whether fecal calprotectin was ≤ 150 µg/g at Month 12 among enrolled participants with data available at termination. It also records that the study was terminated because of low enrollment and that no meaningful analysis can be presented.
It does not provide a numerical primary-endpoint estimate, so the percentage of participants meeting the threshold cannot be stated. It also does not report results for the secondary outcomes or correlations. The study’s objectives are not themselves evidence that fecal calprotectin tracked quality of life, workability, or disease activity in the enrolled participants.
The record cannot support a treatment-effect conclusion. It does not describe a randomized comparator, and it does not report a like-for-like control comparison. Even if measurements had been reported, changes observed during therapy alone would not establish that the therapy caused them. Correlations would indicate associations, not causation.
The available safety counts are descriptive: the registry reports serious adverse events in 2 of 10 at risk and other adverse events in 0 of 10 at risk. Those figures do not establish comparative risks or causal attribution. The deaths value is not reported in the registry record.
In general, a terminated study with limited enrollment can still document its research question, outcome definitions, and the fact that data were collected. But without analyzable results and an appropriate comparison, it cannot answer the clinical question with a reliable estimate. The registry record should therefore be read as a record of the study’s aims and limited posted findings, rather than as evidence for or against an effect of adalimumab.
14. Why This Trial Matters Statistically
AdaProQuo illustrates why an outcome definition and a numerical result are not the same thing. The registry specifies a clear threshold for its primary endpoint and identifies the time point and population of interest. Yet it also states that low enrollment led to termination and that no meaningful analysis can be presented. Without the endpoint estimate, the central statistical question remains unanswered.
The record also highlights the importance of knowing the analysis denominator. The primary population is described as enrolled participants with Month 12 data at termination, but the number with such data is not reported in the registry record. Readers cannot assess how much information supports the endpoint or whether the available measurements represent everyone enrolled.
The study objectives connect a laboratory marker with quality of life, workability, and disease activity. Statistically, those are distinct questions: change over time and association between measures require different summaries and interpretations. The registry lists these outcomes but reports no analyses, so the objectives cannot be mistaken for demonstrated relationships.
Finally, the study makes a useful distinction between planning illustrations and completed evidence. Sample-size illustrations based on an observed effect are not observed power and do not replace a study’s own design justification. The record does not report that justification or a randomized comparison. These limitations show why enrollment, analysis populations, missing-data handling, comparison structure, and uncertainty estimates all matter when interpreting clinical research.
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 principal limitation is the registry’s statement that the study was terminated because of low enrollment and that no meaningful analysis can be presented. Although enrollment is listed as 10, the number of participants with Month 12 fecal calprotectin data is not reported in the registry record. This prevents assessment of the primary endpoint denominator and the amount of information available for the endpoint.
The record does not report a numerical primary-endpoint estimate, secondary-outcome results, confidence intervals, or statistical tests. It lists zero analyses. Consequently, neither the magnitude nor the precision of the intended findings can be evaluated. Missing-data procedures, reasons for unavailable measurements, and analysis populations for secondary outcomes are not reported in the registry record.
The study is not described as a randomized comparison, and allocation is not stated. The posted information therefore does not support a like-for-like comparison with another treatment or a control condition. The registry also does not report the study’s own sample-size justification, a detailed analysis plan, or how multiplicity was addressed. Any planning illustration based on an observed effect should not be confused with the study’s design or with observed power.
The study’s focus on correlations also requires caution: even a reported association would not by itself establish causation. The registry does not report correlation estimates or the methods used to calculate them. Safety interpretation is likewise limited by the absence of a comparison group and by the unreported death value. Details such as event timing and relatedness are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo — NCT02092389.
- Registry record last updated 2017-02-23; status last verified 2017-01.
- Results first posted 2017-02-23.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
AdaProQuo studied adalimumab therapy in patients with moderate to severe ulcerative colitis. Its primary question concerned the percentage with fecal calprotectin ≤ 150 µg/g at Month 12 among enrolled participants with data available at termination. Secondary objectives concerned workability, quality of life, disease activity, and correlations with fecal calprotectin.
The study enrolled 10 participants, started in 2014-07, and had primary completion recorded in 2015-10. Its status is TERMINATED; the registry states that low enrollment led to termination and that no meaningful analysis can be presented. Numerical efficacy analyses are not reported in the registry record. Safety information lists serious adverse events in 2 of 10 at risk and other adverse events in 0 of 10 at risk; deaths are not reported in the registry record. The posted findings do not support a comparative treatment conclusion.