Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis (NCT01248793), a randomized phase 3 study. The primary outcome is Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14.

2. Clinical Question

3. Trial Design

This was a Phase 3, randomized, parallel-group, placebo-controlled study of golimumab in Chinese patients with ankylosing spondylitis. The registry describes the study as double-blind and records quadruple masking. The roles covered by that masking label are not reported in the registry record. The study status is completed, and the listed enrollment is 213.

The primary outcome was assessed at Week 14. The record identifies the analysis population as intent-to-treat: participants were analyzed according to assigned treatment regardless of whether they received that treatment. The two reported groups were placebo, with 105 participants, and golimumab 50 mg, with 108 participants. Allocation was randomized; further details of the allocation procedure are not reported in the registry record.

The record lists the study start as 2010-10 and primary completion as 2011-05. Centocor, Inc. is named as the sponsor. The available design description does not report the original sample-size justification, planned treatment duration beyond the listed outcome time points, interim analyses, or the detailed statistical analysis plan. It also does not explain the handling of any changes in treatment or follow-up. These omissions limit how fully the posted results can be connected to the original protocol.

The posted outcomes include ASAS 20 at Week 14 and Week 24, and changes in BASFI and BASMI at Week 14. The later outcome and the two index measures add context, but the record does not report a set of formal secondary analyses. The safety listing uses a placebo-to-golimumab group as well as a golimumab group; the registry does not provide enough detail to infer additional treatment-period rules from those labels.

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: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment

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 Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14, measured over Week 14.

The primary endpoint is the number of participants achieving ASAS 20 at Week 14. The registry defines a response as at least a 20% improvement in ankylosing spondylitis symptoms, including back pain, function and inflammation. The endpoint is binary for each participant: the participant either meets the response definition at the assessment or does not. The posted group totals therefore describe counts of responders, with each group’s participants as the denominator.

A composite response criterion can summarize change across several symptom domains in a single outcome. It also makes the result interpretable as the proportion of participants who meet a defined threshold, rather than as an average change in one measure. That is a general feature of binary response endpoints; it does not mean every symptom domain changed equally or that the endpoint captures every aspect of disease experience.

The intent-to-treat definition matters to interpretation. Participants remain in the group to which they were assigned, whether or not they received the assigned treatment. This preserves the randomized comparison in principle, but it does not by itself explain how missing Week 14 measurements were treated. The approach to missing outcome data is not reported in the registry record, so the posted counts should be read alongside that uncertainty.

7. Results Posted in the Registry

• Group II: Golimumab 50 mg: 49.1% (53/108) versus 24.8% (26/105) on control; risk difference 24.3 percentage points (95% CI 11.8 to 36.8), risk ratio 1.98 (1.35–2.91); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Group II: Golimumab 50 mg: 50.0% (54/108) versus 22.9% (24/105) on control; risk difference 27.1 percentage points (95% CI 14.8 to 39.5), risk ratio 2.19 (1.47–3.26); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Group II: Golimumab 50 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Group II: Golimumab 50 mg: mean -1.26 versus 0.11 on control; difference -1.38 (95% CI -2.00 to -0.75), standardized effect d = -0.59; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Group II: Golimumab 50 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Group II: Golimumab 50 mg: mean -0.42 versus -0.19 on control; difference -0.23 (95% CI -0.45 to -0.01), standardized effect d = -0.28; z-test p = 0.040.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Group II: Golimumab 50 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes provide a broadly consistent direction of comparison with the primary result. The Week 24 ASAS 20 outcome is another binary response assessment, and its posted unadjusted comparison favors a higher response proportion in the golimumab group. The BASFI and BASMI outcomes are continuous index measures; their posted group comparisons are negative mean differences under the comparison order used. These outcomes add information about response at another time point and about function and metrology, but they measure different features from the primary response criterion.

Consistency in direction across distinct outcomes can support a coherent descriptive account, but it does not make the outcomes interchangeable or prove that each represents the same treatment effect. The Week 24 outcome is related to the primary ASAS 20 measure, while BASFI and BASMI use different scales. Their measurement properties, clinical meaning and analysis details are not fully described in the registry record. The results should therefore be considered alongside their endpoint definitions and the uncertainty attached to each estimate.

The registry lists three secondary outcomes and reports no analyses for them. The displayed secondary comparisons are unadjusted. When several outcomes are examined, the chance of obtaining at least one apparently notable result can increase; in general, a multiplicity plan may address that issue by controlling how evidence is interpreted across comparisons. No such adjustment or hierarchy is reported in the registry record. Consequently, secondary p-values carry less weight than results from a prespecified analysis plan that accounts for multiple comparisons. Their role is supportive and exploratory in the context of the information documented, rather than independent confirmation of the primary result.

The posted pattern can be described without assuming that all secondary findings were prespecified, fully analyzed or protected against missing data. The record does not report those details. The secondary results provide context for the primary comparison, but the primary endpoint remains the clearest focus of the trial summary because it is explicitly identified as primary and has a defined assessment time and population.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
• Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
• Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14

9. Statistical Interpretation

10. Statistical Methods Explained

What does the binary comparison measure?

The primary endpoint records whether each participant met the ASAS 20 response definition at Week 14. A count is reported for each randomized group, and the comparison can be expressed as a difference between group proportions. The posted risk difference is 0.243, with a confidence interval from 0.118 to 0.368. The accompanying proportions are 0.248 in the placebo group and 0.491 in the golimumab 50 mg group. These values are unadjusted comparisons based on the posted group summaries.

In general, a risk difference compares absolute event proportions. It is expressed on the same scale as the proportions and indicates how far apart those proportions are. A risk ratio compares proportions by division, while an odds ratio compares the odds of an event. These measures answer related but nonidentical questions, and their numerical values are not interchangeable. The posted risk ratio is 1.982 and the posted odds ratio is 2.928; each has its own confidence interval. The registry record does not identify a model-based adjustment or a covariate set for these comparisons.

What do the continuous comparisons describe?

BASFI and BASMI are posted as mean changes from baseline, with standard deviations. For these outcomes, the comparison is a mean difference between groups. The BASFI mean difference is -1.375, and the BASMI mean difference is -0.23. A negative sign indicates that the reported mean for the golimumab group is lower than the reported mean for the placebo group under the subtraction order used for the comparison. The registry does not state a separate adjusted analysis for these outcomes.

In general, a mean difference summarizes how far apart two group averages are. A standard deviation describes variability among participant measurements within a group; it is not the uncertainty of the mean difference itself. The posted standard deviations are 2.097 for placebo and 2.57 for golimumab 50 mg on BASFI, and 0.718 and 0.906, respectively, on BASMI. The estimates and intervals summarize group-level data and do not show the spread of individual responses by themselves.

What does a confidence interval contribute?

In general, a confidence interval gives a range of estimates compatible with the observed data under the statistical procedure used. Its width reflects precision: narrower intervals indicate less uncertainty in the estimated contrast, while wider intervals indicate more. A confidence interval does not show the range of individual participant outcomes, and it does not guarantee that the true effect lies within the displayed limits. The registry record does not identify the confidence level or the precise method used to construct the posted intervals, so those details should not be inferred.

The binary primary interval runs from 0.118 to 0.368 for the risk difference. The interval does not include zero. The posted unadjusted p-value is <0.001. In general, a p-value describes how unusual data at least as incompatible with a null hypothesis would be under the assumptions of a specified statistical test; it is not the probability that the null hypothesis is true. The registry does not report the test procedure, and the posted p-values are explicitly unadjusted.

Why does over-dispersion matter in general?

Over-dispersion is a general concern when observed variability in count or binary data exceeds what a model assumes. If a method assumes less variability than the data contain, its standard errors can be too small and its intervals too narrow. This concept is relevant when evaluating statistical models, but the record does not identify an over-dispersion assessment or report a model for the primary binary comparison. It would therefore be inappropriate to claim that over-dispersion was present or handled in this trial.

What can be said about the analysis plan?

The primary population is described as intent-to-treat, with participants analyzed according to assigned group regardless of whether assigned treatment was received. This describes the population principle, not the handling of missing assessments. The registry does not report imputation, rules for incomplete assessments, sensitivity analyses, covariate adjustment, interim analyses, or a sample-size justification. It also does not report detailed analyses for the secondary outcomes. These features are important for understanding how estimates were obtained and how uncertainty was assessed; their absence from the registry record prevents a more specific account.

The posted numerical comparisons are unadjusted. No discrepancy between the posted group summaries and the comparison calculations is flagged in the registry information. That does not make the calculations a substitute for a full protocol or statistical analysis plan. The interpretation is limited to the reported counts, means, standard deviations, estimates, intervals and p-values, and the distinction between descriptive posted results and analyses not documented in the record.

11. Confidence Intervals and Precision

The Week 14 primary risk-difference estimate is 0.243, with a confidence interval from 0.118 to 0.368. The interval represents the uncertainty around the estimated difference between the two group proportions under the method used to produce it. Its endpoints are both on the positive side of zero. The posted unadjusted p-value is <0.001. Because the record does not state the confidence level or interval method, those details are not reported in the registry record and should not be assumed.

Precision is not the same as certainty about every individual outcome. A confidence interval concerns an estimated group contrast, not the range of responses among participants. The groups include 105 participants assigned to placebo and 108 assigned to golimumab 50 mg. Larger samples can generally improve precision when other aspects of design and variability are comparable, but the interval width also depends on the outcome and statistical method. The posted results do not supply an interval for each group proportion separately.

The Week 24 binary comparison and the continuous secondary comparisons also have uncertainty intervals. Their estimates differ in scale: the binary outcome uses a risk difference, while BASFI and BASMI use mean differences. Their intervals should therefore be interpreted in the units of each measure, rather than compared as if they represented the same quantity. The BASMI interval is close to zero at its upper limit, while the BASFI and Week 24 intervals remain on one side of zero. Those observations do not address multiplicity or missing-data uncertainty.

Confidence intervals quantify sampling uncertainty under their statistical assumptions; they do not capture every limitation of a registry summary. Unreported analysis details, potential missing assessments, and the lack of a documented multiplicity approach remain relevant to the strength of interpretation. The estimates are best read as precise to the extent indicated by their own intervals, without extending that precision beyond the recorded outcomes and analysis information.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures for these outcomes are participants per arm, not total events. The planning illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers effects equal to a stated fraction of the observed effect. The registry’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrated number of participants per arm for a design with an 80% chance of detecting the specified effect if that effect were the true effect, under the planning assumptions. The 90% power column gives the corresponding illustration for a design with a 90% chance under those same assumptions. These are prospective planning concepts, not descriptions of what happened in this completed trial. The figures are not observed power.

The planning scenarios use the observed effect as a reference, then consider smaller fractions of it. Smaller effects are harder to distinguish from chance variation and generally require more participants to achieve a given target power. That pattern is visible across the planning values. It should not be read as evidence that the trial was designed for those effects: the registry record does not report the assumptions used for the original design. The illustrations also rely on a normal approximation and equal allocation, so they are not a substitute for an analysis tailored to a fully specified protocol and outcome model.

For this study, the displayed planning illustrations apply to binary and continuous outcomes, so the unit is participants per arm. In general, time-to-event planning may instead use a total number of events; that convention is not the applicable unit for the outcomes.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.248; treatment proportion p₁ = 0.491; average p̄ = 0.369.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6825 = 1.3376.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6605 = 0.5559.
4. n = (1.3376 + 0.5559)² / (0.2431)² = 60.7, rounded up to 61 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.247619047619048                          # control proportion
p1 <- 0.490740740740741                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1248793)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 61 (80% power), 81 (90% power)
 75% of observed effect: n per arm = 105 (80% power), 140 (90% power)
 50% of observed effect: n per arm = 226 (80% power), 302 (90% power)
power.prop.test: 60.7 
Simulated power at n = 61 per arm: 0.806 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record does not report how multiplicity was handled. It lists a primary endpoint and three secondary outcomes, but does not describe a testing hierarchy, adjustment procedure, or allocation of statistical error across outcomes. The p-values accompanying the comparisons are unadjusted. This matters because examining several outcomes can make at least one small p-value more likely by chance, even if no underlying effects are present. That general concern means unadjusted secondary results should be interpreted cautiously and should not be treated as equivalent to a single prespecified primary test.

The record identifies the primary analysis population as intent-to-treat: participants are grouped according to assignment regardless of whether they received the assigned treatment. This is a useful description of the intended comparison, but it does not establish that every participant had an observed Week 14 assessment. The registry does not report the number of missing outcome measurements, how incomplete data were handled, or whether sensitivity analyses were conducted. It is not possible to determine from the record whether missingness could have affected the posted estimates.

The statistical analysis plan is not reported in enough detail to identify the model or test used for the comparisons, whether adjustment for baseline variables was planned, or how protocol deviations were addressed. The registry also does not report interim analyses or a stopping rule. These items should not be inferred from the presence of p-values or confidence intervals. The posted results support interpretation of the recorded summaries, but do not allow a full audit of the intended and implemented analysis procedures.

These omissions are especially important for secondary outcomes, for which no reported analyses are listed and multiplicity adjustment is undocumented. They do not change the values in the registry record, but they limit how strongly those values can be treated as confirmatory evidence. The original sample-size justification is also not reported, so the planning illustrations should not be mistaken for the trial’s prespecified design basis.

15. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: enteritis (1.0%), tuberculous pleurisy (1.0%), uveitis (0.9%), tibia fracture (0.9%), ovarian epithelial cancer (0.9%).

The registry lists serious adverse events in two safety groups. In the Placebo to Golimumab 50 mg group, 2 participants with serious adverse events are listed among 103 at risk. In the Golimumab 50 mg group, 4 participants with serious adverse events are listed among 108 at risk. The record also lists other adverse events in 37 of 103 and 33 of 108 participants, respectively. These are counts from the registry safety listing; they should be read using the group labels as recorded, including the placebo-to-golimumab label.

The registry lists serious-event terms including Enteritis and Tuberculous Pleurisy at 1.0%, and Uveitis, Tibia Fracture, Ovarian Epithelial Cancer and Epistaxis at 0.9%. The record does not identify the arm attribution for those listed terms in the information presented, so they should not be assigned to a particular group. Deaths are not reported in the registry record.

Safety counts are descriptive. The record does not provide enough information about event timing, duration of exposure, severity grading, or statistical comparisons to support a fuller comparative safety analysis. Counts should not be interpreted as proof that a treatment caused or prevented an event.

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

The registry results show that more participants in the assigned golimumab 50 mg group met the ASAS 20 response definition at Week 14 than in the assigned placebo group. The estimated risk difference is 0.243, and its confidence interval runs from 0.118 to 0.368. This is an observed group comparison with a reported unadjusted p-value of <0.001. It describes the primary outcome as recorded; it is not a complete statement about every symptom, outcome, or participant.

The result does not by itself establish the size or persistence of effects outside the listed assessment times. The registry reports Week 14 and Week 24 ASAS 20 outcomes, with BASFI and BASMI changes at Week 14. It does not report longer-term outcomes in the information available. Nor does the response definition establish that all components improved to the same extent, since it is a combined threshold outcome.

The posted comparisons do not answer every question about uncertainty. The record does not report the confidence-interval method, missing-data procedures, detailed analysis plan, or multiplicity handling. Those limitations are important when weighing the p-values, particularly for secondary outcomes. The safety listing gives event counts, but deaths are not reported in the registry record, and the information does not support a complete evaluation of safety over time.

Randomization and the intent-to-treat description provide an important basis for comparing assigned groups, but the registry summary does not provide all details needed to evaluate implementation and analysis. The data should therefore be read as evidence about the posted endpoint summaries and their stated uncertainty, not as an answer to questions the record does not address. No medical recommendation follows from these statistics alone.

17. Why This Trial Matters Statistically

This trial illustrates how a binary clinical response can be reported in several complementary ways. The ASAS 20 counts show how many participants met a defined threshold, while the group proportions and risk difference express the comparison on an absolute scale. The posted risk ratio and odds ratio use relative scales. Reading these measures together helps distinguish the observed response frequency from the size of the between-group contrast.

The confidence interval adds information that a p-value alone cannot convey. It describes a range of plausible values for the estimated risk difference under the method used, while the p-value summarizes compatibility with a null hypothesis under a test. The interval is therefore important for judging precision, even though the confidence level and calculation method are not reported in the registry record.

The record also demonstrates why secondary findings require context. Outcomes at a later time point and on different scales can broaden the picture, but unadjusted analyses across several outcomes raise multiplicity concerns. The trial’s original analysis plan and handling of missing data are not reported, so readers cannot fully reconstruct how the posted comparisons relate to planned analyses.

Finally, planning illustrations based on observed effects should be distinguished from the original design rationale. They show how required sample sizes vary across assumed effect fractions and power targets under stated assumptions; they are not a measure of the trial’s observed power. This separation between observed results, uncertainty, and hypothetical planning is central to careful statistical interpretation.

18. 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.

Several limitations are specific to the information recorded for this trial. The registry lists 213 enrolled participants and two primary outcome groups, but the original sample-size justification is not reported. Planning illustrations based on the observed effect cannot establish what effect the study was originally designed to detect or whether its design assumptions were met.

The record defines the intent-to-treat population but does not report missing outcome counts or missing-data methods. It is therefore not possible to assess whether incomplete Week 14 or later measurements influenced the posted summaries. Detailed analysis methods, including the procedures used for the intervals and p-values, are also not reported in the registry record. The comparisons should be understood as unadjusted posted summaries rather than as fully documented model-based analyses.

Multiplicity handling is not reported despite the presence of several secondary outcomes. The secondary p-values are unadjusted, and no hierarchy or correction is described. The record also lists no reported analyses for the secondary outcomes, which limits the ability to evaluate whether the displayed comparisons match the original statistical plan.

Safety interpretation is constrained by the available event counts and group labels. The listing includes a placebo-to-golimumab group, but does not provide enough detail to infer all exposure-period rules. Deaths are not reported in the registry record. The listed serious-event terms are not attributed to arms in the information presented. These gaps prevent a comprehensive safety comparison from the registry summary alone.

Finally, the design description does not provide details of the masking roles, allocation procedure, or treatment and follow-up procedures beyond the listed outcomes. The record’s completed status and assessment times do not resolve those omissions. These limitations do not negate the posted comparisons, but they define the boundaries of what can be concluded from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis — NCT01248793.
• Registry record last updated 2013-03-20; status last verified 2013-03.
• Results first posted 2012-06-28.
• 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.

22. Record Summary

This completed Phase 3 randomized, parallel-group, placebo-controlled study evaluated golimumab in Chinese patients with ankylosing spondylitis. The registry lists enrollment of 213, with 105 participants in the placebo group and 108 in the golimumab 50 mg group. The primary outcome was ASAS 20 response at Week 14 in the intent-to-treat population.

The posted primary comparison reports 26 responders among 105 placebo participants and 53 among 108 golimumab participants. The unadjusted risk difference is 0.243, with a confidence interval from 0.118 to 0.368 and an unadjusted p-value of <0.001. Secondary outcomes include ASAS 20 at Week 24 and Week 14 changes in BASFI and BASMI. The record does not report multiplicity handling, missing-data procedures, or the original sample-size justification.