Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab (NCT01273519), a registered phase not stated study. The primary outcome is Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12.

2. Clinical Question

3. Trial Design

The registry record describes a study of participants with RA, PsA, and AS who were prescribed adalimumab. The listed group is labeled “RA, PsA, AS,” and the treatment description says adalimumab was prescribed in the usual manner under the local marketing authorization. Enrollment was 155. The study status is completed; the recorded start is 2011-01 and primary completion is 2013-01.

The primary assessment compares participants’ present-pain rating at baseline with the rating at Month 12. Other listed outcomes include SF-36, HAQ-DI, RADAI, BASFI, BASDAI for participants with AS, ESR, and CRP, each assessed at baseline and Months 3, 6, 9, and 12. The registry lists 16 outcome measures overall, but does not give numerical results for these secondary measures in the record described.

The record does not describe a comparator group or state an allocation method. Its caution explicitly notes that this is not a randomized comparison and that the arms are not a like-for-like control comparison. As a result, changes observed over time, if available, would not by themselves distinguish a treatment effect from other explanations, such as the course of disease or changes in care. No protocol details, recruitment setting, eligibility criteria beyond the summary description, or treatment adherence information are reported in the registry record.

The record lists AbbVie (prior sponsor, Abbott) as sponsor. It does not report the full statistical plan, the planned sample-size justification, or whether interim analyses were performed. The primary completion date is a registry milestone; it does not supply the missing outcome estimates or analysis details.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants with an assessment. n=number of participants with an assessment at time point.

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 Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12, measured over Baseline, Month 12.

The primary endpoint is participants’ own rating of present pain intensity at baseline and Month 12. The question asks, “How intensive is your pain at present?” Responses use a four-point Likert scale: 0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain. The stated population is all participants with an assessment at the relevant time point.

This measure captures the participant’s immediate perception of pain rather than an observer’s judgment or a laboratory measurement. A four-category scale can distinguish gradations of reported intensity, while retaining an ordered structure: higher categories represent more severe pain. That makes it useful for describing how participants characterize pain at specified assessments. As a general statistical point, an ordinal scale conveys rank order but does not establish that the distance between adjacent categories is equal.

The record does not report the number of participants in each response category, a summary of changes from baseline, or an estimate comparing baseline with Month 12. It also does not report a threshold defining a clinically important change. Accordingly, the endpoint definition alone describes what was measured, not what participants experienced over time. Pain-medication change is central to the study’s stated purpose, but the primary endpoint listed is the pain-intensity rating rather than a reported medication-use result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry defines the primary outcome as a participant count classified by a four-category pain response at baseline and Month 12. The scale is ordered: no pain, mild pain, moderate pain, and severe pain. The data type is therefore ordinal in meaning. A category label tells the reader which response was chosen, but does not show that the numerical step from no pain to mild pain is equivalent to the step from moderate pain to severe pain.

For an ordinal outcome, useful descriptions can include the number of participants in each category at each assessment, or a distribution that preserves the ordered categories. A single average can be harder to interpret because it treats the category codes as though the spacing between them were uniform. That may be a reasonable modeling choice in some analyses, but it needs to be stated and justified. The registry record does not report which summary or model was used for the pain endpoint.

The stated analysis population includes all participants with an assessment at the time point. This is a time-specific definition: it does not imply that every enrolled participant contributed data at every assessment. Counts assessed at baseline and Month 12, reasons for missing assessments, and the handling of missing data are not reported in the registry record. Those details matter because a comparison of observed responses can be affected if the participants assessed at follow-up differ systematically from those not assessed.

A confidence interval is a general statistical way to express uncertainty around an estimate. It gives a range of values compatible with the data under the assumptions of the method; it is not a guarantee that the true value lies in that range. For an estimated change in pain distribution or a contrast between assessments, an interval would help communicate precision. No confidence interval for the primary endpoint is reported in the registry record. A p-value, if reported, would address compatibility with a specified null model, not the size or practical importance of a change. The registry record does not report a p-value or a null hypothesis for this endpoint.

What does the repeated assessment establish?

Measuring pain at baseline and Month 12 allows a description of participants’ reported pain at two time points. Repeated assessments can help distinguish a within-person pattern from a comparison of unrelated groups, but an analysis must account for the relationship between responses from the same participant. The record does not state whether the primary analysis used paired observations, modeled repeated measures, or another method. Nor does it report whether intermediate observations were used in the primary analysis.

As a general principle, baseline-to-follow-up change is not automatically a treatment effect. In a study without a reported comparator, time trends may reflect treatment, disease course, co-interventions, participant characteristics, or other influences. Randomization can help balance such influences between groups, but the record does not describe randomized allocation. The registry caution also warns that the arms are not a like-for-like control comparison.

How should planning calculations be read?

Sample-size calculations are planning tools that estimate how many participants may be needed to detect a specified effect under stated assumptions. They are not observed outcomes, and they do not show how precisely this completed study estimated its primary endpoint. The planning assumptions described in the registry use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a fraction of the observed effect. These are planning assumptions, not evidence that the study used a two-arm randomized design. The record does not report the study’s own sample-size justification.

When a calculation is based on a fraction of an observed effect, smaller target effects generally require more information to detect than larger target effects, all else equal. This is general statistical context, not a result about this study. Any displayed planning estimates should be interpreted as illustrations conditional on their assumptions, not as “observed power.” The registry record does not report a sponsor analysis from which to compare a recalculation, and no observed primary-effect estimate is reported in the record described.

Why do analysis details matter?

Statistical methods determine how raw responses are converted into estimates and how uncertainty is quantified. For an ordinal pain scale, choices about category handling, repeated measurements, covariate adjustment, and missing observations can affect the estimate and its interpretation. The registry record does not report these choices, an analysis population beyond the time-point assessment definition, or the prespecified statistical plan. In the absence of outcome estimates and methods, the safest interpretation is that the record documents the measurement question and study context but does not support an inferential conclusion about the primary endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 16 outcome measures, including the primary pain assessment and secondary measures of quality of life, function, disease activity, and inflammatory markers. When a study examines many outcomes or time points, the chance of at least one apparently unusual result can increase if each is tested separately without an appropriate plan. This is a general statistical issue known as multiplicity. Methods such as a prespecified hierarchy or adjustment can address it, but the suitable approach depends on the study’s aims and analysis plan.

The registry record does not report whether multiplicity was addressed, which outcomes were treated as confirmatory, or whether any testing hierarchy was prespecified. It also lists 0 analyses, and numerical results for the listed outcomes are not reported in the record described. No conclusions about statistical significance across the outcome set can therefore be drawn.

Missing-data information is also limited. The primary endpoint population is described as all participants with an assessment at the time point, but the number assessed at each time point and the reasons for missing assessments are not reported in the registry record. The record does not say whether missing outcomes were imputed, excluded, or handled using a model. These approaches can rely on different assumptions; without the method and assessment counts, the impact of missingness cannot be judged.

The registry does not report an analysis population beyond the time-point definition, a prespecified statistical analysis plan, or sensitivity analyses for missing data. These omissions do not establish that analyses were not performed outside the posted record. They mean that the methods and their consequences cannot be evaluated from the registry record.

11. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: carotid artery stenosis (0.6%), cerebrovascular accident (0.6%), respiratory tract infection (0.6%), pneumonia (0.6%), treatment failure (0.6%).

For the listed RA, PsA, AS group, 155 participants were at risk in the serious adverse event listing and 3 were recorded with a serious adverse event. The separate other-adverse-event listing also gives 155 at risk, with 21 recorded with an other adverse event. These are counts of participants with an event, as indicated by the registry’s description of the outcome type.

The serious adverse event terms listed are carotid artery stenosis, cerebrovascular accident, respiratory tract infection, pneumonia, treatment failure, and breast cancer; each is shown as 0.6%. The registry record does not explain whether participants could contribute to more than one term, so the term percentages should not be added or treated as a partition of the participants with serious events. They describe the listed terms individually, not an overall rate.

The record does not report deaths in the safety listing. A missing death value is not the same as a reported count of zero. The safety figures are descriptive for the listed group and do not provide a comparison with an untreated or alternative-treatment group. They also do not, by themselves, establish whether an event was caused by treatment. The registry record does not report a causal attribution analysis or a comparative safety estimate.

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

The record documents a study involving people with RA, PsA, or AS who were prescribed adalimumab and a stated interest in pain intensity and pain-medication use. It defines the primary pain question, its four ordered response categories, and the time points of baseline and Month 12. It also records enrollment of 155 and describes additional clinical and health-status measures.

What the record does not establish is whether pain intensity changed, whether pain medication was changed, reduced, or stopped, or how large or precise any such change was. The posted results do not include a primary-outcome estimate, category counts, a confidence interval, or a p-value. The study’s stated purpose must not be mistaken for evidence that the intended change occurred.

Even if a within-participant change were reported, the absence of a described comparator would limit causal conclusions. Participants’ health and pain can change over time for reasons other than treatment. The record notes that this is not a randomized comparison and cautions that the arms are not like-for-like controls. Thus, the record cannot establish what would have happened to comparable participants without adalimumab.

The safety counts describe participants with reported adverse events in the listed group. They do not provide a comparative estimate or establish that treatment caused an event. Likewise, missing death information should not be interpreted as a zero count. Overall, the registry record is useful for identifying the question, population, endpoint, and recorded safety counts, but it does not provide the outcome analyses needed to quantify change or support a treatment-effect conclusion.

13. Why This Trial Matters Statistically

This study’s statistical question is clinically recognizable: it connects a participant-reported pain rating with the use of pain medication during treatment for RA, PsA, or AS. Pain is not captured fully by disease activity measures or laboratory values alone, so recording the participant’s own assessment offers a distinct perspective. The registry also lists functional and health-status measures, alongside disease activity and inflammatory markers, reflecting different dimensions of assessment.

Statistically, the repeated pain assessment raises important questions about how ordinal responses are summarized, how within-participant dependence is handled, and how missing assessments affect interpretation. These are not merely technical details. They shape what an estimated change means and how confidently it can be interpreted. The registry record defines the scale and assessment times but does not report the analysis method or numerical primary results.

The study also illustrates why the presence of a baseline and follow-up assessment is not equivalent to a controlled comparison. Without a reported comparator and randomized allocation, an observed trajectory cannot by itself separate treatment-related change from other influences. That distinction is essential when translating longitudinal observations into causal claims.

Finally, the record’s broad outcome set makes transparent analysis planning important. Prespecifying the primary comparison, treatment of missing observations, and approach to multiple outcomes would help readers assess the credibility and precision of results. Those details are not reported in the registry record. The statistical importance of this trial record therefore lies not in a quantified treatment effect, which is unavailable, but in the measurement and design questions required to interpret such an effect responsibly.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The central limitation for interpreting this record is that numerical results for the primary pain endpoint are not reported. There are no response-category counts or estimates of change at baseline and Month 12 in the record described. The registry lists 0 analyses, so no inferential result for the primary or secondary outcomes is available there. The stated study aim cannot fill that gap.

The record describes no comparator group and does not state an allocation method. Its caution says this is not a randomized comparison and that the arms are not a like-for-like control comparison. This prevents a direct controlled estimate of how outcomes differed from an alternative course of care. The listed group also includes three disease conditions, but disease-specific enrollment and outcome summaries are not reported.

The primary outcome definition includes only participants with an assessment at the relevant time point. Assessment-specific counts, reasons for missing observations, and missing-data methods are not reported in the registry record. Consequently, it is not possible to assess whether follow-up observations represent all enrolled participants or whether missingness could influence the observed pattern.

The statistical analysis plan, sample-size justification, multiplicity approach, and use of interim analyses are not reported in the registry record. The record also does not report detailed information on pain medicines or results describing medication changes. Safety counts are descriptive and lack a comparison group; the death value is not reported. These limitations concern what can be interpreted from the record, not proof that additional information or analyses do not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab — NCT01273519.
• Registry record last updated 2014-03-26; status last verified 2014-02.
• Results first posted 2014-02-24.
• 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.

18. Record Summary

The registry record concerns participants with RA, PsA, or AS prescribed adalimumab, with the stated purpose of assessing pain intensity and changes in pain-medication use. Enrollment was 155; the study is marked completed, with start recorded as 2011-01 and primary completion as 2013-01. The primary endpoint is a participant-rated, four-category present-pain assessment at baseline and Month 12.

Additional listed outcomes include SF-36, HAQ-DI, RADAI, BASFI, BASDAI for participants with AS, ESR, and CRP. The record lists 16 outcome measures and 0 analyses. Numerical primary and secondary outcome results, analysis methods, and missing-data handling are not reported in the registry record. The safety listing records 3 participants with serious adverse events and 21 with other adverse events among 155 at risk in the listed group. No comparator is described, and the record cautions that this is not a randomized comparison.