Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) (NCT02750800), a registered phase not stated study. The primary outcome is Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months.

2. Clinical Question

The study's stated objective was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in routine clinical practice in Hungary. Its title emphasizes the incremental impact of the support program on patient-reported outcomes and health resource utilization, but the registry record does not describe a comparison that isolates the program's contribution from the effects of treatment, participant characteristics or routine care.

The clinical question is therefore descriptive in the available record: it concerns change over time among participants receiving the combined treatment and support program. Without a described comparison group, an observed change would not by itself establish what would have happened without the program or without adalimumab. The registry record does not report a primary-outcome estimate or the number of participants contributing evaluable data.

3. Trial Design

NCT02750800 is recorded as a completed post-marketing observational study sponsored by AbbVie. The record gives a start date of 2016-04-07, a primary completion date of 2018-04-03 and an enrollment of 427. It took place in Hungary and included participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease or ulcerative colitis.

The described treatment combined adalimumab and AbbVie Care 2.0. Adalimumab was administered by subcutaneous injection for 12 months, according to the approved EMA label and Hungarian financial protocols; supportive services were provided through the patient support program. The registry does not describe a separate group receiving adalimumab without the program, a group receiving the program without adalimumab, or another control group. Allocation is not stated.

The primary outcome was the mean change from baseline in SF-36 V2 Physical Component Summary score at 12 months. The record also lists patient-reported outcomes covering mental health-related quality of life, general health status, disease-specific quality of life for several conditions, and satisfaction with treatment and medicine information. It lists health resource utilization in the study title, but the outcome measures and results available in the record do not provide a specific health-resource-utilization estimate.

Although the study status is completed, completion does not mean that outcome results are available in the registry record. The record lists 22 outcome measures and zero analyses. It does not report a primary-outcome estimate, its variability, a confidence interval, or a statistical test result. Thus, the design and intended measurements can be described, but the magnitude and precision of the clinical outcomes cannot be evaluated from this 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.

Before assignment: Full Analysis Set: participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of adalimumab

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants in the Full Analysis Set with evaluable 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.

Population: Full Analysis Set: participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of adalimumab

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months, measured over Baseline (Month 0) and 12 months.

The primary endpoint is the mean change from baseline in the SF-36 V2 Physical Component Summary score at 12 months. The SF-36 V2 is a health assessment questionnaire intended to characterize quality of life. Its items address physical functioning, limitations in usual roles related to physical health, bodily pain, general health perceptions, vitality, social functioning, limitations in usual roles related to emotional problems, and general mental health. Items concerning physical functioning, physical-role limitations, bodily pain and general health primarily contribute to the PCS; the other listed domains primarily contribute to the Mental Component Summary.

The questionnaire scores range from 0, described as worst, to 100, described as best. A positive change from baseline indicates improvement according to the registry's endpoint description. The endpoint is used to summarize change in a patient-reported measure of physical health-related quality of life over the stated follow-up period. A mean describes the average change across participants with evaluable data; it does not show how much individual participants varied or how many experienced a particular degree of change.

The registry record does not report the mean change, standard deviation, confidence interval or number of participants with evaluable endpoint data. The direction convention and scoring range are described, but the actual primary-outcome result and its precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical explanation: A mean change is the average of participants' individual changes between baseline and follow-up. It provides a summary of the direction and average size of change, but can conceal differences among participants. The registry specifies a mean and standard deviation as the summary measures for the primary outcome. The mean change and standard deviation themselves are not reported in the registry record.

What does the standard deviation describe?

General statistical explanation: A standard deviation describes how spread out individual values are around their mean. It is not the same as the uncertainty in the estimated mean. Uncertainty in a mean also depends on how many observations contribute and on the analysis method. Because the primary-outcome standard deviation and evaluable sample size are not reported in the registry record, the variability in changes and the precision of an estimated average cannot be assessed.

How would a confidence interval help?

General statistical explanation: A confidence interval gives a range of values compatible with the data and the statistical method used, expressing uncertainty around an estimate. It can help readers distinguish a relatively precise estimate from one that is uncertain. The registry record does not report a confidence interval for the primary outcome. Without one, and without the estimate itself, the precision of the result cannot be evaluated. A confidence interval would not by itself address confounding or establish that the support program caused a change.

What does the observational design imply?

General statistical explanation: In an observational study, treatment and support are observed in routine care rather than assigned through a randomized comparison. Participants may differ in characteristics that also relate to outcomes, and changes over time may reflect influences other than the intervention. Random allocation can help balance measured and unmeasured factors on average, while a suitable control group can help distinguish changes associated with treatment from changes that would otherwise occur. The registry record describes no randomized comparison and no comparator group; allocation is not stated. The described data therefore do not establish the incremental effect of the support program.

How should the planning illustrations be read?

General statistical explanation: Sample-size planning illustrations describe how much information a hypothetical comparison might require under specified assumptions. The registry record states that the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation and a target effect defined as a stated fraction of an observed effect. For non-time-to-event outcomes, the reported planning unit is participants per arm for 80% power or other stated power levels; time-to-event planning uses a total number of events. These are planning assumptions, not evidence about the completed study's actual design or observed power.

The study description lists the combined adalimumab and support-program intervention, not two randomized arms. The registry record does not report the sample-size justification for the study or provide the observed primary-outcome estimate needed to interpret a planning illustration based on an observed effect. Any planning values should therefore be understood as hypothetical illustrations rather than as the number enrolled, a design target confirmed by the registry, or a measure of the study's achieved power. A sample-size calculation cannot substitute for the missing outcome estimate and uncertainty.

Why does over-dispersion matter?

General statistical explanation: Over-dispersion occurs when variation in data is greater than a statistical model expects. If a model assumes less variation than the data contain, estimated uncertainty can be too small, which can make results appear more precise than warranted. Different outcome types and analysis models require different approaches to variability. The registry record does not describe an analysis model for the primary outcome or report a diagnostic assessment of over-dispersion. The primary endpoint is a continuous measure summarized as a mean and standard deviation, and the record does not provide results that would permit assessment of its variability.

The registry lists zero analyses and does not report a statistical analysis plan, adjustment strategy, model specification or sensitivity analyses. Those details are not reported in the registry record. It is therefore not possible to determine from this record how repeated measurements, confounding, missing observations or multiple outcomes were handled. General statistical methods can clarify what such choices mean, but cannot fill in details that the registry does not document.

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.

R code and output

arm <- c("Ankylosing Spondylitis", "Crohn's Disease", "Psoriasis", "Psoriatic Arthritis", "Rheumatoid Arthritis", "Ulcerative Colitis")
n   <- c(60, 49, 51, 55, 48, 44)
m   <- c(11.02, 7.63, 4.38, 12.26, 11.81, 9.02)
sp  <- c(10.24, 9.51, 9.14, 10.73, 10.83, 8.65)
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  Ankylosing Spondylitis  60  11.020  10.240  8.375  13.665
CARM  Crohn's Disease  49  7.630  9.510  4.898  10.362
CARM  Psoriasis  51  4.380  9.140  1.809  6.951
CARM  Psoriatic Arthritis  55  12.260  10.730  9.359  15.161
CARM  Rheumatoid Arthritis  48  11.810  10.830  8.665  14.955
CARM  Ulcerative Colitis  44  9.020  8.650  6.390  11.650

11. Multiplicity, Missing Data and Analysis Populations

The record lists 22 outcome measures, including a primary SF-36 V2 PCS outcome and multiple secondary patient-reported measures. When many outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for multiplicity. General approaches include identifying a primary outcome in advance, adjusting tests or confidence intervals, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy, testing hierarchy or statistical analysis plan. It is therefore not reported in the registry record whether or how multiple comparisons were addressed.

The record does not provide results for the listed primary or secondary outcomes, despite listing zero analyses. It also does not report the number of participants with evaluable data at each measurement time, the amount or pattern of missing outcome data, or the methods used to handle missingness. These omissions matter because an analysis based only on participants with observed follow-up data can differ from one that uses other assumptions or methods, especially if missingness is related to health status or outcome changes. The registry record does not describe whether such differences were assessed.

The primary outcome population is described as the Full Analysis Set with evaluable data. The size and operational definition of that set are not reported in the registry record, nor are the number enrolled, the number followed, and the number analyzed distinguished for the primary outcome. Without these details, the extent of attrition and the representativeness of the analyzed participants cannot be assessed. These are reporting gaps, not evidence about whether missingness occurred or how it affected results.

12. Safety Results

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

Deaths

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

Serious events with the highest arm-level rate: colitis ulcerative (0.7%), cardiopulmonary failure (0.2%), anal fistula (0.2%), crohn's disease (0.2%), death (0.2%).

The registry lists 412 participants as at risk for serious adverse events in the adalimumab and AbbVie Care 2.0 group, with 19 participants affected by serious adverse events and 2 deaths. These counts describe the safety information posted for this group. The record lists zero participants at risk for, and zero affected by, other adverse events in the corresponding fields. Those entries should not be read as proof that no non-serious events occurred in all study records; the registry's displayed categories and reporting are the basis for the figures.

The serious-event terms listed include ulcerative colitis at 0.7%, and cardiopulmonary failure, anal fistula, Crohn's disease, death and erysipelas at 0.2% each. The registry record does not clarify the denominator used for these term percentages or whether a participant could contribute more than one term. The percentages therefore should be read as registry-listed values, not recalculated or treated as mutually exclusive proportions.

These figures do not establish that an event was caused by adalimumab or the support program. The registry record does not provide a comparison group, detailed event narratives, timing, attribution assessments or a complete safety analysis. The counts are descriptive and should not be used alone to compare risks across treatments or populations.

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

The registry record establishes that a completed post-marketing observational study was conducted in Hungary, with an enrollment of 427, to assess adalimumab together with AbbVie Care 2.0 in inflammatory arthritis, psoriasis and inflammatory bowel diseases. It identifies a primary patient-reported outcome, the change in SF-36 V2 PCS score from baseline to 12 months, and lists additional quality-of-life and satisfaction outcomes. It also posts serious adverse event information for the described group.

It does not report the primary endpoint estimate, the variability of that estimate, a confidence interval, a statistical test or the number of participants with evaluable primary-outcome data. It therefore does not show how much average change was observed or how precisely that change was estimated. The endpoint's scoring description says positive change indicates improvement, but the direction and size of the study's actual result are not reported in the registry record.

The record also does not provide a described comparison group that could isolate the additional contribution of the support program. Because the study is observational and allocation is not stated, changes over time cannot be attributed to the program or to adalimumab alone from this record. This does not show that either component had no effect; it means the record does not support a causal estimate of their separate or combined effects.

The safety counts are likewise descriptive. Without a comparator and further details about event ascertainment and attribution, they cannot establish comparative risk or causation. The record is informative about study purpose, setting, intervention, intended outcome measures and posted serious-event counts. It is insufficient for judging the magnitude, precision or cause of patient-reported changes, or for evaluating the incremental impact of the support program.

14. Why This Trial Matters Statistically

This study is statistically notable because it addresses outcomes that patients report about physical health and quality of life in a routine-care setting. The primary SF-36 V2 PCS endpoint focuses on the physical component of health-related quality of life, while the listed secondary measures cover mental health-related quality of life, general health status, disease-specific quality of life and satisfaction. Such outcomes complement clinical assessments by capturing aspects of health that patients experience directly.

The study also illustrates a key distinction between describing change and estimating an intervention's incremental effect. Measuring participants at baseline and 12 months can describe how scores change over time. To attribute that change to a particular component, such as the patient support program, a comparison must address what would have happened without that component. The registry record does not describe such a comparator or a randomized allocation, and it does not report an adjusted comparison.

Its post-marketing, routine-care setting is relevant to the intended context, but does not remove the need for transparent reporting of the analysis population, missing data, outcome estimates and uncertainty. The registry record lists the planned outcomes and enrollment but does not report outcome analyses. Consequently, the study's intended statistical contribution can be understood, while its empirical findings and precision cannot be assessed from this record.

The record provides a useful example of why study status and registry completeness are different: completed status does not supply an outcome estimate. It also underscores that safety counts and patient-reported outcomes need context, denominators and appropriate comparisons before they can support conclusions about treatment effects or program impact.

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 for interpreting this specific study from the registry record is the absence of posted outcome analyses. Although the primary endpoint and secondary measures are named, the record does not report their estimates, variability, confidence intervals or test results. The record lists zero analyses. Completion status does not resolve this gap.

The registry describes an observational study with adalimumab and AbbVie Care 2.0, but no comparator group is described and allocation is not stated. The design information available therefore does not permit a like-for-like assessment of outcomes with and without the support program. The study's title refers to incremental impact, but the registry record does not provide a comparison that would isolate that impact.

The enrollment is reported as 427, while the primary outcome applies to participants in the Full Analysis Set with evaluable data. The size and definition of that population, follow-up completeness, and missing-data handling are not reported in the registry record. These gaps prevent assessment of attrition and of how representative the analyzed population would be.

The record lists multiple outcome measures but does not report how multiplicity was handled, what statistical models were used, whether analyses adjusted for relevant factors, or whether sensitivity analyses were performed. The sample-size justification and the trial's own statistical plan are not reported in the registry record. The safety information is also limited to listed counts and terms; the registry record does not provide event attribution, timing or a comparator-based safety analysis. These limitations concern the available reporting and the described design; they do not establish that an unreported analysis or procedure was absent from the study itself.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) — NCT02750800.
• Registry record last updated 2019-11-06; status last verified 2019-09.
• Results first posted 2019-11-06.
• 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

NCT02750800 is a completed post-marketing observational study sponsored by AbbVie, conducted in Hungary, with an enrollment of 427. Its stated objective was to evaluate adalimumab plus the AbbVie Care 2.0 patient support program in routine clinical practice among participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease or ulcerative colitis.

The primary outcome was mean change from baseline to 12 months in SF-36 V2 PCS score among participants in the Full Analysis Set with evaluable data. The record lists 22 outcome measures but zero analyses, and does not report the primary or secondary outcome results. It describes no comparator group; allocation is not stated.

For the described group, the registry lists 412 participants at risk for serious adverse events, 19 affected and 2 deaths. These are descriptive registry figures, not evidence of causation or comparative risk. The record establishes the study's purpose and intended measurements, but does not allow assessment of outcome magnitude, precision or the support program's incremental effect.