Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED) (NCT00818272), a registered phase not stated study. The primary outcome is Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment.

2. Clinical Question

The study's stated purpose was to implement a tool intended to increase and monitor physicians' awareness of tuberculosis screening and reinforce patient eligibility for Remicade according to the product information. The primary endpoint is a measure of screening practice and documentation. It does not directly measure Crohn's disease activity or compare the clinical effects of treatments.

A secondary outcome was assessment of disease activity using the Crohn's Disease Activity Index (CDAI) at enrollment and at the first infusion. Results for that outcome are not reported in the registry record. The clinical question that can be addressed from the available information is therefore narrow: which first screening test was recorded, and how completely was it documented? The record states the categories but does not provide the observed counts needed to answer that question.

3. Trial Design

The registry record identifies this as an observational study of people with Crohn's disease. Its status is COMPLETED, with enrollment of 148. The recorded study start is 2002-12 and primary completion is 2010-12. Those dates describe the registry record; they do not establish the length of an individual participant's observation.

Remicade (infliximab) is the named intervention. The described group consists of participants with confirmed active Crohn's disease. The record does not identify a comparator group, does not state how treatment allocation was made, and does not describe a randomized comparison. The available information therefore supports a descriptive account of screening practice in the treatment context, rather than a comparative estimate of treatment effects.

The primary outcome was measured at baseline, before treatment administration. It counted participants according to whether the Mendel Mantoux test was the first tuberculosis screening test, was not the first test, or had no entry. The registry explanation cautions that a missing entry may mean another first test was performed and documented. This definition makes the endpoint partly about recorded practice: an absent entry cannot automatically be interpreted as absence of screening.

The registry record lists five outcome measures and identifies the CDAI assessment at enrollment and at the first infusion as a secondary outcome. It does not report the observed CDAI results, timing details beyond those named assessments, or further follow-up procedures. The number of analyses reported is 0. A statistical analysis plan, analysis populations, and any sample-size justification for the study itself are not reported in the registry record. These omissions limit what can be concluded about how the observations were collected or analyzed.

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

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 Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment, measured over Baseline.

The primary endpoint counts participants whose first screening test for active or latent tuberculosis, before starting treatment, was the Mendel Mantoux test. This is a tuberculin sensitivity skin test performed by intradermal injection. The registry record classifies the result as Yes, No, or Missing and places the assessment at baseline.

This endpoint is used to describe a screening process, rather than a clinical outcome of Crohn's disease or an effect of infliximab. The stated study aim was to increase and monitor awareness of tuberculosis screening and reinforce patient eligibility in line with the product information. Recording which test was first can therefore indicate whether the specified screening practice was documented in the treatment context.

The distinction between No and Missing matters. No means the Mendel Mantoux test was not the first screening test; Missing means no entry was recorded. The registry explanation notes that a missing entry may still correspond to another screening test having been performed and documented. Thus, Missing is not interchangeable with No and does not by itself establish that screening did not occur.

The endpoint's category counts are not reported in the registry record. Without those counts, the distribution across Yes, No, and Missing cannot be described. Nor can the record establish from this endpoint alone whether screening changed awareness, affected eligibility decisions, or influenced clinical outcomes.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a categorical count: participants are assigned to Yes, No, or Missing according to whether the Mendel Mantoux test was the first tuberculosis screening test before treatment. A count tells how many observations fall into a category. A proportion can also describe the share of a defined group in a category, but the registry record does not provide the category counts or a reported proportion. No new proportion can be derived from the enrollment count alone.

What does a confidence interval describe?

General statistical explanation: a confidence interval represents uncertainty around an estimated quantity under the assumptions of the method used. It is not a guarantee about an individual participant, and it does not correct a biased or incomplete measurement process. For a categorical screening endpoint, an interval could express uncertainty around an estimated category frequency if the necessary count, denominator, and analysis method were reported. No confidence interval for the primary endpoint is reported in the registry record, so its numerical precision cannot be assessed.

Why does the category definition matter?

The endpoint distinguishes No from Missing. No is a substantive category: the Mendel Mantoux test was not the first screening test. Missing refers to no entry and, as the registry explanation notes, may occur even when another first test was performed and documented. General statistical explanation: combining these categories can obscure the difference between an observed alternative and an absent record. Treating every missing entry as a negative response would require an assumption that the registry record does not make.

The measurement also depends on what was documented. A recorded test sequence is not necessarily identical to the full screening process unless recording is complete. The registry record states that screening was performed and documented before treatment as part of the study description, but it does not give an independent validation method, a completeness assessment, or rules for resolving incomplete entries. Those details are not reported in the registry record.

What does an observational design imply?

General statistical explanation: observational studies describe data collected without a randomized treatment assignment. They can provide useful descriptions of practice, but comparisons between groups, when present, may be affected by differences in who receives each treatment and why. This record does not identify a comparator or state allocation, and the stated screening endpoint is not a treatment-effect contrast. It therefore does not supply a basis for attributing differences in outcomes to infliximab.

Enrollment of 148 is reported, but enrollment is not necessarily the denominator for every outcome analysis. The number with a recorded primary endpoint, the number excluded from any analysis, and the handling of incomplete observations are not reported in the registry record. General statistical explanation: a denominator should match the analysis question and the observations available for that outcome. Assuming all enrolled participants contributed a complete endpoint could misstate the amount of information.

How should planning calculations be understood?

The record describes sample-size calculations as planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It further describes the target effect as a stated fraction of the observed effect. These are planning assumptions, not evidence that the study used that design: the registry record describes an observational study and does not identify a two-arm randomized comparison. The numerical planning outputs and an observed effect are not reported in the registry record, so no specific planning requirement can be interpreted.

General statistical explanation: a planning calculation asks what amount of information might be needed to detect a chosen effect under assumed conditions. It is not the probability that a completed study has found a true effect, and it should not be described as observed power. Such calculations depend on the assumed effect, variability, allocation, and analysis method. If those assumptions do not match the study, the resulting illustration may not represent the study's actual design or precision.

General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. In count or categorical data, an inadequate variability assumption can make uncertainty estimates too narrow. The record does not report a model for the primary endpoint, a dispersion assessment, or inferential analyses. Accordingly, there is no basis to say that over-dispersion was assessed or to attribute any analysis to the investigators.

The registry lists 0 analyses. A count endpoint can be summarized descriptively without a hypothesis test, but the underlying category counts are not reported. The record also does not report an adjustment strategy, confidence intervals, or model specifications. General statistical explanation about tests and uncertainty can clarify what those methods would mean if reported; it cannot substitute for absent results or establish which methods were used.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures and 0 analyses. It identifies the first tuberculosis screening test at baseline as the primary outcome and lists CDAI assessment at enrollment and at the first infusion as a secondary outcome. The results for these outcomes, beyond the safety counts described separately, are not reported in the registry record.

Multiplicity concerns arise when several outcomes or statistical comparisons are tested. General statistical explanation: the more questions tested, the greater the chance that at least one result may appear noteworthy by chance if each is interpreted without regard to the others. A prespecified hierarchy or adjustment approach can address this issue, but no multiplicity strategy is reported in the registry record. The record does not report inferential analyses, so it is not possible to assess how any multiplicity issue was handled.

Missingness is especially relevant to the primary endpoint because Missing is an explicit category. The registry definition says it represents no entry and may mean that another test was performed first and documented. Thus, the missing category is not a confirmed absence of screening. The counts in all categories are not reported, and the record does not describe imputation, exclusion, or other missing-data handling.

The analysis populations are not reported in the registry record. Although enrollment is 148, the number contributing to each outcome or any analysis cannot be assumed from enrollment alone. The record also does not report a protocol-defined analysis set, a method for handling incomplete records, or whether any participants were excluded. These omissions prevent assessment of whether the analyzed participants, if any, represented all enrolled participants.

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 5% reporting threshold.

For the Infliximab group, the registry record lists 148 participants at risk for serious adverse events and 0 affected. For other adverse events, it likewise lists 148 at risk and 0 affected. These are the reported counts for those two safety categories. No serious adverse-event terms are listed. The record does not report a death count.

At-risk counts identify the group used for the reported safety figures; they do not describe the duration of observation. The safety observation period, event definitions, collection procedures, and handling of incomplete safety information are not reported in the registry record. The counts therefore should be read as registry entries, not as a complete account of every possible event over an independently established period.

A zero affected count means that the record reports no participants affected in that listed category. It does not establish that risk is absent or that events could not occur in other settings or observation periods. Nor do these counts compare infliximab with an untreated or alternative-treatment group: a comparator is not identified. The available safety figures are descriptive, and the record does not provide further detail for interpreting them comparatively.

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

The registry record establishes that the study was observational, concerned tuberculosis screening before infliximab treatment in people with active Crohn's disease, and defined a primary endpoint based on the first screening test recorded at baseline. It also reports enrollment of 148 and identifies the endpoint categories as Yes, No, and Missing. These details describe the question and how the primary outcome was categorized.

The record does not report the counts in those categories. Therefore, it cannot establish how often the Mendel Mantoux test was the first screening test, how often another test came first, or how often documentation was missing. It also does not report results for the listed CDAI assessments. The endpoint definition and study purpose alone cannot show whether awareness increased or eligibility decisions changed.

This study does not provide a randomized treatment comparison in the information available. A comparator is not identified, and allocation is not stated. The primary outcome is a screening-process measure, not a direct measure of treatment benefit. It cannot establish whether infliximab changes Crohn's disease activity or whether its clinical effects differ from another treatment.

The reported safety counts are 0 affected for serious adverse events and 0 affected for other adverse events, each among 148 listed at risk in the Infliximab group. Those figures do not provide information about a comparison group, and the safety observation period is not reported. They should not be interpreted as proof of no risk.

Overall, the record supplies useful context about the screening question and the study's observational character, but it does not report the central primary outcome counts or a statistical analysis. Conclusions about the frequency or precision of documented screening, changes in awareness, or clinical treatment effects would go beyond the reported results.

13. Why This Trial Matters Statistically

This study illustrates why an endpoint's meaning and its recording process both matter. The primary outcome is not simply whether screening occurred: it asks whether a specified test was the first screening test and separates a recorded No from a Missing entry. That distinction preserves information about documentation and avoids treating an absent record as a confirmed negative result.

The study also demonstrates the difference between a process measure and a clinical outcome. The stated goal concerned awareness of tuberculosis screening and patient eligibility in the context of Remicade. The primary measure records screening practice; it does not directly quantify disease activity or compare treatment outcomes. Keeping those questions separate is essential to interpreting the endpoint without overstating what it can establish.

Its observational design is another important statistical feature. No comparator is identified, and allocation is not stated. Descriptive evidence about a care process can be relevant without being a randomized treatment comparison, but it cannot answer the same causal question. The available safety counts are likewise descriptive and have no comparator in the registry record.

Finally, the record's missing outcome counts limit statistical interpretation. Enrollment alone does not reveal how participants were distributed among the endpoint categories, and the record does not report an analysis or confidence interval. This example underscores that an endpoint definition, a study purpose, and enrollment information are not substitutes for the observed outcome data. Transparent reporting of category counts, denominators, missingness, and analysis methods is needed to evaluate the result's size and precision.

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 primary limitation for interpreting the main question is that the registry record defines the screening categories but does not report their counts. Without those observations, the frequency of the Mendel Mantoux test as the first screening test cannot be described, and no estimate or uncertainty interval can be assessed.

The record identifies the study as observational and does not identify a comparator or state allocation. It therefore does not support a randomized or like-for-like comparison. The stated purpose concerns screening awareness and eligibility, but outcomes for awareness or eligibility decisions are not reported. The endpoint itself describes screening practice rather than a direct clinical treatment outcome.

The handling of missing entries is also uncertain. The record says Missing represents no entry and may mean another first test was performed and documented, but it does not report how many entries were missing or how they were handled analytically. The number contributing to each outcome cannot be inferred from the enrollment count. Analysis populations and missing-data procedures are not reported.

Further details about the endpoint's measurement, including validation of documentation and rules for incomplete records, are not reported in the registry record. CDAI is listed as a secondary outcome at enrollment and at the first infusion, but its results are absent. The registry lists five outcome measures and 0 analyses, and does not report an analysis plan or multiplicity approach.

For safety, the record lists 148 at risk and 0 affected for both serious and other adverse events in the Infliximab group, but does not report the observation period or further event-collection details. Deaths are not reported in the registry record. These omissions constrain interpretation of both the safety counts and the main screening endpoint.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED) — NCT00818272.
• Registry record last updated 2015-09-03; status last verified 2015-09.
• Results first posted 2012-02-01.
• 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 describes an observational study of Crohn's disease, with enrollment of 148 and status COMPLETED. The recorded study start is 2002-12 and primary completion is 2010-12. Remicade (infliximab) is the named intervention, and the described participants had confirmed active Crohn's disease.

The primary outcome counts participants whose first tuberculosis screening test before treatment was the Mendel Mantoux test, categorized as Yes, No, or Missing at baseline. The category counts are not reported in the registry record. CDAI assessment at enrollment and at the first infusion is listed as a secondary outcome, but its results are not reported.

The registry record does not identify a comparator, state allocation, or report an analysis plan. It lists five outcome measures and 0 analyses. In the Infliximab group, 148 participants are listed at risk and 0 affected for serious adverse events; the same counts are listed for other adverse events. The safety observation period and death count are not reported in the registry record.