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 A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis (NCT00336492), a randomized phase 3 study. The primary outcome is The Number of Participants With Clinical Response at Week 8.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00336492 |
| Phase | Phase 3 |
| Condition | Ulcerative Colitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Centocor, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Children with moderately to severely active ulcerative colitis. The primary efficacy endpoint analysis was based on all treated participants. The registry record lists enrollment of 60 participants, but does not give a fuller description of eligibility criteria or the characteristics of participants at baseline.
Intervention
Infliximab, an infusion, was studied using different dosing schedules. One arm description starts with 5 mg/kg at weeks 0, 2, and 6, followed by dosing every 8 weeks through week 46; participants could receive 10 mg/kg every 8 weeks up to week 46. The other starts with the same initial schedule, followed by dosing every 12 weeks through week 42; participants could receive 10 mg/kg or 5 mg/kg every 8 weeks up to week 42. The record does not explain the criteria for these possible dose changes.
Comparator
The described arms use infliximab in both groups, with different planned intervals and possible dose changes. The record identifies the study as randomized and parallel-group, but the primary endpoint information does not report a between-arm comparison. A placebo or non-infliximab comparator is not described in the posted arm descriptions.
Primary question
The primary endpoint is the number of participants with clinical response at week 8. Response is defined using a reduction from baseline in Mayo score together with a specified change in rectal bleeding. The posted registry record does not give the response count, an effect estimate, a confidence interval, or a test comparing groups. Thus, the endpoint and its definition are available, but the primary result is not reported in the registry record.
In practical terms, the study asks whether participants met a symptom-based clinical-response definition after the initial treatment period. It is not possible to use the registry record alone to estimate how often response occurred, whether the regimens differed, or how precisely any difference was estimated. The secondary outcome listed is PUCAI remission at week 54, but its result is not reported in the registry record either.
3. Trial Design
The registry identifies this as a phase 3, randomized, open-label, parallel-group, multicenter trial. It lists ulcerative colitis as the condition, an enrollment of 60, and completed status. The study dates recorded are a start in 2006-09 and primary completion in 2009-05. The sponsor is Centocor, Inc. These entries describe the registered study; they do not establish what was reported in a full publication or any later analysis.
The intervention descriptions are two infliximab regimens. Both begin with 5 mg/kg at weeks 0, 2, and 6. One then describes dosing every 8 weeks through week 46, with the possibility of 10 mg/kg every 8 weeks up to week 46. The other describes dosing every 12 weeks through week 42, with the possibility of 10 mg/kg every 8 weeks or 5 mg/kg every 8 weeks up to week 42. The registry does not state how or when participants became eligible for these dose options, so the descriptions should not be read as a complete account of dose adjustment rules.
The safety section presents a not randomized group and two groups named for 5 mg/kg infliximab every 8 weeks and every 12 weeks. It lists 15 participants at risk in the not randomized group, 22 in the every-8-weeks group, and 23 in the every-12-weeks group. Those are safety-table group counts; they should not be substituted for an endpoint analysis population. The primary efficacy description says that analysis was based on all treated participants, without giving its size.
The record lists no masking, which is consistent with its open-label designation. It does not report the randomization procedure, allocation concealment, site count, treatment adherence, or reasons for discontinuation. These omissions limit how fully the design can be reconstructed from 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 | Not Randomized Group | 5 mg/kg Infliximab Every 8 Wks | 5 mg/kg Infliximab Every 12 Wks |
|---|---|---|---|
| STARTED | 15 | 22 | 23 |
| COMPLETED | 0 | 18 | 12 |
| NOT COMPLETED | 15 | 4 | 11 |
Reasons for not completing this period:
| Reason | Not Randomized Group | 5 mg/kg Infliximab Every 8 Wks | 5 mg/kg Infliximab Every 12 Wks |
|---|---|---|---|
| Adverse Event | 4 | 3 | 6 |
| Lack of Efficacy | 6 | 1 | 4 |
| Other | 5 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The primary efficacy endpoint analysis was based on all treated participants.
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.
| Characteristic | Unit | Not Randomized Group | 5 mg/kg Infliximab Every 8 Wks | 5 mg/kg Infliximab Every 12 Wks | Total |
|---|---|---|---|---|---|
| Participants analysed | 15 | 22 | 23 | 60 | |
| Age Continuous | years | 11.9 (SD 2.64) | 13.7 (SD 3.20) | 14.2 (SD 3.03) | 13.4 (SD 3.10) |
| Sex: Female, Male: Female | Participants | 7 | 12 | 13 | 32 |
| Sex: Female, Male: Male | Participants | 8 | 10 | 10 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as The Number of Participants With Clinical Response at Week 8, measured over Week 8.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with clinical response at week 8. It uses the Mayo score, described as ranging from 0 to 12 points, with lower scores indicating less disease activity and higher scores indicating more. A clinical response requires a decrease from baseline of at least 30% and at least 3 points, together with a decrease in the rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0 or 1.
This kind of endpoint is intended to capture improvement across symptom-related disease activity, rather than relying on a single symptom alone. The specified threshold makes the response definition more operational: a participant either meets the stated criteria or does not. The registry also says treatment-failure rules were applied when determining final response status. These rules cover discontinuation of study agent due to lack of therapeutic effect, colectomy or ostomy, and protocol-prohibited medication changes.
General statistical context: a binary response endpoint can be summarized as a count of participants meeting the definition, and may also be compared across groups using a difference or ratio of response probabilities. Such comparisons require the observed counts and an analysis method. The registry record gives the definition and analysis population description, but not the response counts or a comparative estimate. The clinical meaning and precision of the endpoint result therefore cannot be assessed from this record alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive constraint is that the registry record does not report the primary endpoint result. It names clinical response at week 8 and defines how response was classified, but gives no count of participants who responded, no group-specific results, and no treatment contrast. There is consequently no basis to describe the observed efficacy pattern or its precision. No p-value or confidence interval for the primary endpoint is reported in the registry record.
The two described treatment groups both received infliximab, though their planned dosing intervals differ and the descriptions permit changes in dose or interval. A randomized, parallel-group design can support a comparison of assigned strategies when the outcome data and analysis are available. In this case, the posted primary endpoint information does not show that comparison. Nor does it explain how participants were allocated among the listed schedules or how dose changes were handled in the primary analysis.
The endpoint analysis population is described as all treated participants. That statement is useful, but it does not reveal how many participants were treated, whether all randomized participants were included, or how missing week 8 assessments were handled. The registry says treatment-failure rules were applied to final response status for specified events. It does not state whether other missing information was imputed, treated as nonresponse, or handled by another method.
The secondary outcome is the number of participants with PUCAI remission at week 54. Its listing shows that the registry included another outcome measure, but there is no result for it in the posted record. The record indicates two outcome measures and one analysis, without enough detail to determine which analyses were performed, how the analysis count is defined, or whether the secondary outcome was formally tested. The testing sequence and any adjustment for multiple comparisons are not reported in the registry record.
Safety counts are available for serious adverse events and other adverse events in the listed groups. The serious adverse-event counts are 5 of 15 in the not randomized group, 4 of 22 in the 5 mg/kg every 8 weeks group, and 5 of 23 in the 5 mg/kg every 12 weeks group. These are descriptive counts. The record does not give a comparative safety analysis, event timing, exposure-adjusted rates, or a definition of the safety observation period. The counts alone do not establish whether events were caused by treatment or whether groups differed in underlying risk.
General statistical context: an estimate is more informative when presented with an uncertainty interval, because the interval conveys the range of values compatible with the observed data under the analysis assumptions. Here, neither an efficacy estimate nor its uncertainty interval is posted. The reader should distinguish an absent result from a result showing no difference: the registry record does not support either conclusion. Any planning illustration elsewhere on the page is not an observed result and should not be read as evidence about treatment effect.
9. Statistical Methods Explained
General statistical context: clinical trial interpretation usually separates the design, the endpoint definition, the analysis population, the estimate, and the uncertainty around that estimate. Each answers a different question. The design describes how treatments were assigned; the endpoint describes what was measured; the analysis population defines whose data contribute; and the estimate and its uncertainty summarize the observed comparison. The registry record contains design and endpoint details, but it does not contain the primary endpoint estimate or its uncertainty.
What does a binary endpoint represent?
The primary outcome is a count of participants classified as having clinical response at week 8. Because the endpoint is binary at the participant level, each participant is assigned a response status based on the stated criteria. Counts can be used to describe the number meeting the definition, while a group comparison would generally need a denominator as well as a numerator. A comparative analysis could express the contrast in several ways, but the registry does not report the counts or the chosen contrast. No effect measure should be inferred from the endpoint title alone.
The response criteria combine a change in the total Mayo score with a condition based on rectal bleeding. This creates a rule-based endpoint: satisfying one part without satisfying the other is not enough under the wording in the record. The Mayo score range is 0 to 12 points, with 0 described as least disease activity and 12 as most. The registry also specifies treatment-failure rules that affect final response classification. Those rules are part of the endpoint implementation, rather than a statistical estimate of treatment effect.
Why does the analysis population matter?
The primary efficacy description says the analysis was based on all treated participants. This is the only explicit primary analysis-population statement in the record. It is not equivalent to a full description of an intention-to-treat analysis, which would need a clear account of who was randomized and how participants were analyzed. The registry does not state whether every randomized participant received treatment, how many were included in the endpoint analysis, or whether any participants were excluded. The safety section separately lists a not randomized group and two named treatment groups; those safety group labels do not establish the primary efficacy analysis set.
General statistical context: analysis populations matter because exclusions after assignment can affect how well a randomized comparison preserves the balance created by randomization. A treated-participant analysis may answer a different question from an analysis retaining every randomized participant in their assigned group. The record does not provide enough detail to determine the consequences of the population choice in this study.
How should uncertainty and significance be read?
A confidence interval is a statistical summary of uncertainty around an estimate, under the assumptions of the method used. It helps distinguish a relatively precise estimate from one that remains compatible with a broad range of effects. A p-value, when reported, measures how unusual data at least as extreme as those observed would be under a specified null model; it is not the probability that a treatment works or that the null hypothesis is true. Neither a confidence interval nor a p-value for the primary endpoint appears in the registry record, so there is no posted inferential result to interpret.
The sample-size assumptions described for planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed trial findings and not a record of the original study's design justification. The registry does not report the trial's own sample-size justification. The primary endpoint comparison is not available for a two-arm planning calculation in the posted analysis because fewer than two arms are represented in the primary outcome results.
What can the safety counts tell us?
The safety table reports the number at risk and the number affected for serious adverse events and other adverse events in each listed group. A count is a description of participants with an event, not necessarily a count of distinct event episodes. The record does not state whether a participant with multiple events is counted once or more than once in these summaries, nor does it give the duration of exposure used for each group. General statistical context: when exposure time differs, raw counts may not provide a fair comparison of event frequency; an exposure-adjusted rate may be useful if the required data are available. Those data are not reported.
Over-dispersion is a general statistical issue that can arise when count data vary more than a simple model assumes. It matters because standard errors and uncertainty intervals can be too narrow if the model fails to represent that extra variability. The posted record does not describe a count model or an over-dispersion assessment for safety outcomes. Since the registry provides descriptive affected-participant counts rather than a model-based safety comparison, there is no basis to infer that such a model was used.
Finally, registry entries are not a substitute for a complete statistical analysis plan. The plan for missing outcomes, covariate adjustment, interim analyses, multiplicity, subgroup analyses, and sensitivity analyses is not reported in the registry record. These omissions mean that readers cannot reconstruct the full analytic pathway from the endpoint definition and counts alone.
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 |
|---|---|---|---|---|---|---|
| Infliximab 5 mg/kg | 60 | 44 | 73.3% | 60.3% to 83.9% | 61.0% to 82.9% | 60.9% to 82.9% |
R code and output
arm <- c("Infliximab 5 mg/kg")
n <- c(60)
events <- c(44)
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 Infliximab 5 mg/kg 60 44 73.3 60.3 83.9 61.0 82.9 60.9 82.911. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: clinical response at week 8 and PUCAI remission at week 54. It also records one analysis, but does not describe which outcome that analysis concerns or how the analysis count was defined. The registry does not report a testing hierarchy, a primary-versus-secondary testing sequence beyond labeling the primary endpoint, or any adjustment for multiple comparisons. It is therefore not possible to determine from this record how the risk of false-positive findings across outcomes was addressed.
Missing-data procedures are also not reported in the registry record. The endpoint description states that treatment-failure rules were applied to determine final response status for participants who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes. This clarifies the response classification for those specified circumstances, but does not explain the handling of missing assessments for other reasons, incomplete score components, or withdrawal from follow-up.
The stated primary efficacy analysis population is all treated participants. The record does not provide its size or explain how it relates to randomized participants, participants with an available week 8 assessment, or participants included in the final response count. It also does not report sensitivity analyses to examine the impact of missing data or alternative response classifications. These gaps limit assessment of the robustness of any result, especially because the primary result itself is not posted.
General statistical context: multiplicity concerns arise when several outcomes or analyses are tested and interpreted together. Missing-data methods matter because the analysis can depend on assumptions about outcomes that were not observed. Neither issue can be resolved by the safety counts or by the endpoint definition alone.
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 |
|---|---|---|---|
| Not Randomized Group | 5 | 15 | 33.3% |
| 5 mg/kg Infliximab Every 8 Wks | 4 | 22 | 18.2% |
| 5 mg/kg Infliximab Every 12 Wks | 5 | 23 | 21.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Not Randomized Group | 10 of 15 |
| 5 mg/kg Infliximab Every 8 Wks | 19 of 22 |
| 5 mg/kg Infliximab Every 12 Wks | 22 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | Not Randomized Group | 5 mg/kg Infliximab Every 8 Wks | 5 mg/kg Infliximab Every 12 Wks |
|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | 4 of 15 | 2 of 22 | 3 of 23 |
| Anemia | Blood and lymphatic system disorders | 0 of 15 | 1 of 22 | 0 of 23 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 15 | 0 of 22 | 0 of 23 |
| Pancreatitis | Gastrointestinal disorders | 0 of 15 | 1 of 22 | 0 of 23 |
| Cellulitis | Infections and infestations | 0 of 15 | 1 of 22 | 0 of 23 |
| Infection | Infections and infestations | 0 of 15 | 1 of 22 | 0 of 23 |
| Infection Viral | Infections and infestations | 0 of 15 | 1 of 22 | 0 of 23 |
| Urinary Tract Infection | Renal and urinary disorders | 0 of 15 | 0 of 22 | 1 of 23 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 0 of 22 | 1 of 23 |
| Pneumonia Lobar | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 22 | 0 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Not Randomized Group | 5 mg/kg Infliximab Every 8 Wks | 5 mg/kg Infliximab Every 12 Wks |
|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | 1 of 15 | 7 of 22 | 15 of 23 |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 7 of 22 | 6 of 23 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | 3 of 15 | 4 of 22 | 4 of 23 |
| Abdominal Pain | Gastrointestinal disorders | 3 of 15 | 3 of 22 | 2 of 23 |
| Fever | Infections and infestations | 1 of 15 | 6 of 22 | 1 of 23 |
| Headache | Nervous system disorders | 2 of 15 | 3 of 22 | 3 of 23 |
| Anemia | Blood and lymphatic system disorders | 0 of 15 | 4 of 22 | 2 of 23 |
| Coughing | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 2 of 22 | 3 of 23 |
| Pain | General disorders | 1 of 15 | 0 of 22 | 4 of 23 |
| Vomiting | Gastrointestinal disorders | 1 of 15 | 1 of 22 | 2 of 23 |
Serious events with the highest arm-level rate: colitis ulcerative (26.7%), neutropenia (6.7%), pneumonia lobar (6.7%), anemia (4.5%), pancreatitis (4.5%).
The safety table lists serious adverse events and other adverse events separately. For serious adverse events, the not randomized group had 15 participants at risk and 5 affected; the 5 mg/kg infliximab every 8 weeks group had 22 at risk and 4 affected; and the 5 mg/kg infliximab every 12 weeks group had 23 at risk and 5 affected. For other adverse events, the corresponding counts affected were 10, 19, and 22, with the same group sizes at risk: 15, 22, and 23.
These are descriptive participant counts. The record does not report a statistical comparison between groups, the time participants were observed, or exposure-adjusted event rates. It also does not state whether an affected participant could contribute to more than one adverse-event category. The listed counts therefore should not be interpreted as evidence that one regimen caused more or fewer events.
The registry lists serious-event terms with percentages: colitis ulcerative, 26.7%; neutropenia, 6.7%; pneumonia lobar, 6.7%; anemia, 4.5%; pancreatitis, 4.5%; and cellulitis, 4.5%. The record does not provide the denominators or clarify how these terms relate to individual treatment groups in this summary. Deaths are not reported in the registry record.
13. What the Result Does, and Does Not, Mean
This record establishes that a randomized, open-label, parallel-group phase 3 study of infliximab regimens in pediatric ulcerative colitis was registered and completed. It documents the primary endpoint definition, a secondary remission outcome, treatment schedules, and descriptive safety counts. Those details are useful for understanding what the study intended to assess and how some outcomes were classified.
However, the primary efficacy result is not reported in the registry record. There is no response count by group, no between-group estimate, and no uncertainty interval or significance test. The secondary outcome result is also absent. The posted record therefore cannot establish the magnitude or precision of an efficacy difference, whether the trial met an efficacy objective, or whether any apparent difference was compatible with chance under a specified analysis.
The safety counts show how many participants were listed as affected in each safety group. They do not by themselves establish causation or provide a complete comparison of risks. Interpretation would require details such as event timing, follow-up duration, exposure, definitions, and analysis methods, many of which are not reported in the registry record.
General statistical context: a trial's design and outcome definition are not the same as its result. Likewise, the absence of a posted estimate is not a finding of no effect. Any planning illustration based on an observed effect is a hypothetical aid for thinking about future study size, not evidence that the intervention did or did not change the outcome in this study. The record supports a description of the registered design and selected safety counts, while leaving the central comparative efficacy question unanswered.
14. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a registered endpoint and a reported endpoint result need to be distinguished. The record defines a week 8 clinical response using a change in Mayo score and rectal bleeding, and it identifies the primary analysis population as all treated participants. Yet it does not post the response counts or a comparative estimate. Without those results, readers cannot assess effect size, precision, or the compatibility of the data with a null comparison.
The design also highlights the importance of describing treatment strategies precisely. The two arm descriptions share an initial infliximab schedule but differ in planned maintenance intervals and list possible dose changes. The criteria governing those changes are not reported in the registry record. That matters statistically because a comparison between treatment strategies depends on knowing what participants were assigned to and how deviations or changes were handled.
The record further illustrates why analysis populations, missing-data rules, and multiplicity plans belong alongside outcome definitions. It identifies two outcomes but gives little detail about which analyses were performed, and it does not explain missing assessment handling beyond specified treatment-failure rules. Those decisions can affect both the estimate and its uncertainty.
Finally, the safety table offers useful descriptive information but not a comparative risk analysis. Counts without follow-up time, exposure details, or a stated comparison method have a limited interpretive scope. The statistical lesson is not that the trial supports a particular treatment conclusion; it is that careful interpretation requires the result, methods, and uncertainty to accompany the design.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation of this registry record is the absence of the primary endpoint result. Although the clinical-response definition and analysis population are described, the number of participants meeting the endpoint and any group comparison are not reported in the registry record. The secondary outcome, PUCAI remission at week 54, is listed without its result.
The registry describes the study as open-label, but does not explain whether outcome assessment was blinded or how symptom-based assessments were standardized. General statistical context: lack of masking can create the possibility that knowledge of assigned treatment influences reporting or assessment, particularly for outcomes involving symptoms. This is a potential design concern, not evidence that bias occurred in this study.
The record does not give the randomization method, allocation concealment, baseline group characteristics, participant flow, adherence, or reasons for discontinuation. It also does not explain the criteria for the possible infliximab dose changes listed in the arm descriptions. These details would help clarify how the planned regimens were implemented and how the randomized comparison should be interpreted.
Information about missing-data handling, multiplicity, interim analyses, covariate adjustment, and sensitivity analyses is not reported in the registry record. The stated all-treated analysis population is not accompanied by its size or a detailed account of participant inclusion. Safety information is limited to affected-participant counts and selected serious-event terms; the observation period and exposure-adjusted rates are not given, and deaths are not reported in the registry record.
The registry lists enrollment of 60, but enrollment alone does not indicate how many participants contributed to each outcome. Nor does it show whether the trial had adequate precision for its primary comparison. The registry's own sample-size justification is not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis — NCT00336492.
- Registry record last updated 2013-07-30; status last verified 2013-07.
- Results first posted 2011-08-10.
- 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.
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19. Record Summary
The registry describes a completed phase 3, randomized, open-label, parallel-group, multicenter study of infliximab in pediatric patients with moderately to severely active ulcerative colitis. Enrollment is listed as 60, with a start in 2006-09 and primary completion in 2009-05. Two infliximab dosing schedules are described.
The primary endpoint is clinical response at week 8, defined using Mayo score and rectal bleeding criteria, with treatment-failure rules applied to final response status. The primary efficacy analysis is described as based on all treated participants. PUCAI remission at week 54 is listed as a secondary outcome.
The registry record does not report primary or secondary outcome results, comparative efficacy estimates, confidence intervals, or p-values. It does report serious and other adverse-event participant counts by group and selected serious-event terms. The safety counts are descriptive and do not establish comparative risk or causation.