Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip (NCT03382262), a randomized phase 2 study. The primary outcome is Concentration of Triamcinolone Acetonide (TA) in Blood Plasma.

2. Clinical Question

The study concerns systemic exposure following local joint injection, rather than a reported comparison of symptom relief or joint function. Its stated question is pharmacokinetic: it describes drug concentration in plasma after the two formulations. The registry record includes both shoulder and hip osteoarthritis, but also reports hip-index patients excluded from the primary analysis because of investigational product administration deviations. It does not report a separate numerical result for either joint population. Accordingly, the clinical question can be described from the design and endpoint, but the posted record does not support a conclusion about which formulation had higher or lower exposure, or how precisely exposure differed.

3. Trial Design

NCT03382262 is recorded as a completed Phase 2 randomized study. It used a parallel-group model and compared FX006 32 mg with TAcs 40 mg. Each intervention was a single intra-articular injection. The registry describes the study as open-label, with no masking. Enrollment was 55. The listed conditions were osteoarthritis of the shoulder and osteoarthritis of the hip.

The study start date is 2017-12-18, and the primary completion date is 2018-10-09. Those dates describe the registry timeline; they do not give the timing of an individual participant’s follow-up. The primary endpoint’s timeframe is 12 Weeks. Sampling was scheduled before treatment and at specified post-dose times on Day 1, followed by scheduled assessments on Days 2, 3, 5, 8, 15, 22, 29, 57, and 85. The record describes these collections as part of the pharmacokinetic profile assessment.

Random allocation is intended to make treatment groups comparable on average with respect to measured and unmeasured baseline characteristics, although it cannot ensure exact balance in a study of this size. The registry does not report the allocation sequence method, allocation concealment, or whether randomization was stratified by joint. These details are not reported in the registry record.

Because the study was open-label, participants and study staff were not masked to assigned treatment according to the masking field. The registry record does not explain whether laboratory personnel assessing plasma concentrations were masked. It also does not report the protocol’s sample-size justification, the intended treatment allocation ratio, or any interim analyses. Those design details therefore cannot be inferred from the enrollment total or from the trial’s completed status.

The primary pharmacokinetic population was more restricted than enrollment: the record states that 50 of 55 patients were included, with eligibility based on receiving study drug, completing scheduled sampling, and having sufficient plasma concentration data. It also notes that four unique patients for whom hip was the index joint were excluded because of investigational product administration deviations. The accompanying population description is incomplete, so further details of exclusions cannot be established 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All patients in the Safety population who received study drug, completed scheduled sampling and had sufficient plasma concentration data. 50 of 55 patients were included. Four unique patients for whom hip was the index joint were excluded due to IP administration deviations. One of the four was also found to be enrolled at 2 separate study centers.

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 Concentration of Triamcinolone Acetonide (TA) in Blood Plasma, measured over 12 Weeks.

The primary endpoint is concentration of triamcinolone acetonide in blood plasma, expressed in pg/mL. The record characterizes the measure as a geometric mean with a 95% confidence interval and gives a timeframe of 12 Weeks. The sampling schedule covers measurements from before treatment through Day 85, with intensive post-dose collection on Day 1 and subsequent scheduled collections.

Plasma concentration is used in pharmacokinetic research to describe how much drug is present in the circulation over time after administration. For a medicine injected into a joint, measuring plasma levels can characterize systemic exposure even though the intervention is delivered locally. Concentration-time observations can describe the time course of exposure; the registry description says the objective was to characterize the pharmacokinetic profile of FX006 and TCA IR.

A geometric mean is a summary appropriate for positive measurements that may vary multiplicatively or be skewed. In general, it reflects a central level on a multiplicative scale rather than the arithmetic average. A confidence interval expresses uncertainty around an estimate under the statistical model used; narrower intervals indicate greater precision, while wider intervals indicate less precision. These are general interpretations of the statistical summaries, not claims about the specific values in this study.

The registry record does not report the estimated geometric means, their confidence limits, or the numerical concentration results at individual collection times. It therefore does not permit assessment of the observed exposure level, between-treatment contrast, or precision. The listed endpoint and its measurement schedule explain what was intended to be measured, but are not themselves evidence of a treatment difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a pharmacokinetic concentration measure. The record identifies triamcinolone acetonide in blood plasma, uses pg/mL as the unit, and specifies a geometric mean with a 95% confidence interval. The stated timeframe is 12 Weeks. The record also describes the endpoint as a characterization of the pharmacokinetic profile, with collection times extending from the pre-treatment assessment through Day 85.

What does a geometric mean summarize?

General statistical explanation: A geometric mean summarizes a set of positive measurements using their multiplicative scale. It is often useful when measured values are right-skewed or when proportional changes are of interest. Compared with an arithmetic mean, it is less influenced by a few very high observations when values vary multiplicatively. This general property explains why geometric means are common in pharmacokinetic reporting; it does not reveal how the concentrations in this study were distributed.

The registry does not describe the exact estimation procedure, any transformation used, or the handling of model assumptions beyond the stated concentration rules for below-quantification observations. Those methods are not reported in the registry record. The geometric mean label should therefore not be taken as proof of a particular model or adjustment.

What does a confidence interval communicate?

General statistical explanation: A confidence interval expresses uncertainty around an estimate, conditional on the sampling and analysis method. It is not a range containing a fixed proportion of individual measurements, and it does not by itself establish clinical importance. Its width conveys precision: a more precise estimate generally has a narrower interval, while less precise information generally produces a wider interval. For this trial, the registry reports that intervals were used but does not report their limits. Precision cannot be evaluated without those values.

Why collect concentrations over time?

The stated schedule includes pre-treatment and post-dose sampling on Day 1, followed by scheduled collections on Days 2, 3, 5, 8, 15, 22, 29, 57, and 85. Repeated measurement can describe the concentration-time profile rather than relying on a single observation. In general, the timing and density of measurements influence what parts of a profile can be characterized. The record gives planned collection times but does not report actual concentrations, whether every scheduled sample was obtained, or the analysis used to summarize the full profile.

The primary endpoint timeframe is 12 Weeks, while the listed collection schedule reaches Day 85. The registry record presents both details without explaining the relationship between the timeframe label and the last scheduled collection. They should be reported as recorded rather than treated as evidence of a particular follow-up definition.

How should below-quantification values be understood?

The record describes rules for BLOQ measurements in pharmacokinetic analysis and individual concentration-versus-time plots. A value below the lower limit of quantification before the first measurable concentration is assigned zero. A BLOQ value after a measurable value, when followed by a value above the lower limit, is treated as missing. A BLOQ value at the end of collection after the last quantifiable concentration is set to zero. If two BLOQ values occur in succession after Cmax, the profile is considered to have terminated at the first BLOQ value and later concentrations are set to zero for pharmacokinetic calculations.

General statistical explanation: Measurements below an assay’s quantification limit are not ordinary observed concentrations: their exact values are not known within the assay’s measurable range. Analysts must choose a rule or model for handling them. Different rules can affect estimated profiles, especially when such measurements are frequent. The record’s specified rules make clear that handling depended on where the BLOQ value occurred in the profile. It does not report how many such values occurred or how sensitive results were to alternative handling.

What does randomization contribute?

General statistical explanation: Random assignment helps reduce systematic differences between treatment groups at baseline, on average. It supports a fair comparison when allocation is implemented as planned and outcomes are analyzed appropriately. It does not guarantee that groups will be identical, prevent missing measurements, or remove uncertainty from estimates. In this trial, randomization is recorded, but the sequence generation and concealment methods are not reported in the registry record.

The study is parallel-group and open-label. In a parallel design, each participant is assigned to a treatment group rather than receiving both interventions in a crossover sequence. Open-label status means treatment assignment was not masked as described in the record. Plasma concentrations are laboratory measurements, but the registry does not state whether laboratory assessment was blinded. The potential relevance of that omission depends on the measurement and conduct procedures, which are not reported.

No trial analysis is reported in the registry record. The record lists no numerical endpoint estimates, confidence limits, or sponsor analysis, and it does not provide a statistical analysis plan. The sample-size assumptions described in the registry are planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are not observed power and do not establish the actual design rationale or the precision achieved. The protocol’s sample-size justification is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The endpoint description involves measurements collected at multiple times, and the registry’s outcome listing is not reduced to a single comparison because the primary outcome has several categories or time points. When many time-specific comparisons are considered, the chance of at least one apparently unusual result can increase. General approaches to multiplicity include defining a primary time point in advance, adjusting inference across comparisons, or treating time-specific estimates as descriptive. Which approach was planned or used in this trial is not reported in the registry record.

The record reports no analyses, so it does not show which time points or summary measures were analyzed, whether any comparisons were prespecified, or whether multiplicity was addressed. No interim analyses or statistical analysis plan are reported. It would be inappropriate to assume either that multiplicity adjustment was performed or that it was omitted from the sponsor’s analysis outside the registry.

The primary pharmacokinetic population is described as patients who received study drug, completed scheduled sampling, and had sufficient plasma concentration data. The registry states that 50 of 55 patients were included. It also identifies four unique hip-index patients excluded for investigational product administration deviations, while the population description is incomplete. The record does not provide a complete participant flow or explain all reasons for non-inclusion.

The stated handling of BLOQ values is specific to their timing within a concentration profile. Before a first measurable concentration, a BLOQ value is assigned zero; some intermediate BLOQ values are treated as missing; end-of-collection BLOQ values are set to zero; and successive BLOQ values after Cmax trigger profile termination for calculations. These are analysis rules for censored or unquantifiable measurements, not a general account of all missing data.

The number and pattern of missing samples, the reasons for missed collections, any imputation beyond the stated BLOQ rules, and sensitivity analyses are not reported in the registry record. The record therefore does not establish how robust the endpoint would be to alternative missing-data assumptions.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists safety counts separately for FX006 32 mg and TAcs 40 mg within the shoulder and hip groups. Serious adverse events are recorded as zero in each of the four listed groups. The at-risk counts for those entries are 12 and 13 in the shoulder groups, and 15 and 15 in the hip groups. The registry also lists other adverse events: 4 for FX006 32 mg Shoulder, 3 for TAcs 40 mg Shoulder, 4 for FX006 32 mg Hip, and 7 for TAcs 40 mg Hip.

These figures are descriptive counts as recorded. The registry does not provide the terms for the other adverse events in this summary, their severity, timing, duration, or whether investigators considered them related to study drug. It also does not report a formal statistical comparison of safety between groups. The counts should not be read as evidence that one treatment caused more events than another.

The zero serious-event counts indicate that no serious adverse events were recorded in the listed groups in this registry summary. They do not establish that the risk of such events is absent; small groups and limited observation can leave substantial uncertainty. The record does not state a safety follow-up window or provide enough detail to assess event ascertainment. There were no deaths recorded in the listed groups.

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

This record establishes that a randomized, open-label Phase 2 study was conducted to compare systemic triamcinolone acetonide exposure after a single intra-articular injection of FX006 32 mg or TAcs 40 mg in patients with shoulder or hip osteoarthritis. It describes the primary endpoint as plasma concentration, summarized as a geometric mean with a 95% confidence interval, and gives the collection schedule and certain rules for handling concentrations below quantification.

It does not report the numerical primary endpoint results or analyses. Consequently, the record cannot show whether measured exposure was greater after one formulation, how large any difference might have been, or how precisely a comparison was estimated. The title, objectives, and endpoint definition describe the intended question; they are not findings. Without numerical estimates and intervals, statistical uncertainty and the observed concentration profiles cannot be assessed.

The record also does not provide a reported clinical outcome comparison. It therefore cannot establish a difference in symptoms, function, or other patient-centered outcomes. The stated study focus is systemic exposure, not a reported test of clinical benefit. No medical conclusion about which intervention should be used follows from the information recorded.

Interpretation is further limited by the analysis population description: 50 of 55 patients were included, and the record notes hip-index exclusions due to administration deviations. The text describing the population is incomplete, and detailed participant flow is not reported. The record does not report the analysis plan, handling of general missing samples beyond the BLOQ rules, multiplicity strategy, or results by joint.

The adverse event counts provide a limited safety description, not a comparative safety estimate. Serious adverse events and deaths are recorded as zero in each listed group, while other adverse events are counted without their terms or relatedness. The registry information supports describing these entries, but not assigning causation or concluding that risks differ. Overall, the record documents the study question and some design and safety details, while leaving the principal efficacy-of-exposure comparison unanswered in the posted results.

13. Why This Trial Matters Statistically

This trial is statistically notable for focusing on systemic exposure after an intra-articular intervention. Local administration does not itself quantify how much drug enters the circulation; plasma concentration measurements provide a way to characterize that exposure over time. The scheduled sampling from Day 1 through Day 85 reflects the aim of describing a profile rather than relying on a single observation.

The comparison also illustrates why endpoint definition and result reporting must be distinguished. A geometric mean and a 95% confidence interval identify the intended form of summary, but the absence of their numerical values prevents readers from judging both the estimate and its precision. A well-described endpoint is not a substitute for a reported analysis.

The study includes shoulder and hip populations, and the registry identifies hip-index participants excluded because of administration deviations. That makes population definition relevant to interpretation: the analyzed group is not described simply as everyone enrolled. Clear reporting of participant flow and analysis populations helps readers understand which participants contribute to an estimate and how exclusions may affect generalizability.

The endpoint is assessed across repeated collection times, and the registry specifies rules for handling BLOQ values. Both features are common sources of analytical choices in pharmacokinetic studies. The handling of values below quantification can influence a concentration-time profile, while multiple time points raise questions about which summaries are primary and how comparisons are interpreted. The record documents some measurement rules, but does not report the planned multiplicity approach or numerical results.

The registry also underscores the value of separating descriptive safety counts from comparative inference. Counts by treatment and joint can describe what was recorded, but without event details, uncertainty estimates, and a stated analysis they do not establish a treatment-related difference. Here, the most important statistical conclusion is a reporting boundary: the design and measurement strategy are described, but the comparative exposure estimates are not available in the registry record.

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 main limitation for interpreting this trial from the registry record is the absence of numerical primary endpoint results. Although plasma concentration, the geometric-mean summary, the confidence-interval type, and the timeframe are specified, no estimates or confidence limits are reported. The record also reports no analyses. Comparative exposure magnitude, direction, and precision therefore remain unknown.

The population description is incomplete. The record states that 50 of 55 patients were included in the primary pharmacokinetic population and notes four unique hip-index patients excluded because of investigational product administration deviations. It does not fully explain the remaining participant flow or complete the accompanying exclusion text. The characteristics of included and excluded participants are not reported in the registry record.

The trial was open-label, and masking of laboratory personnel is not reported. The registry does not describe random sequence generation, allocation concealment, stratification, or the statistical analysis plan. These omissions limit assessment of implementation and analytical choices from the record; they do not establish that the procedures were absent.

The primary endpoint involves repeated concentration measurements. While BLOQ handling rules are described, the record does not report the number of values affected, actual missing-sample patterns, or sensitivity analyses. The multiplicity approach for the multiple time points is also not reported. There are no results broken out by shoulder and hip, so possible differences by joint cannot be evaluated.

The safety summary lists serious and other adverse event counts but does not give event terms for the other adverse events, investigator judgments of relatedness, or a clearly described safety observation window. The summary is not a formal comparative safety analysis. These limitations constrain interpretation of both exposure and safety; they do not justify inferring unreported outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip — NCT03382262.
• Registry record last updated 2024-01-24; status last verified 2024-01.
• Results first posted 2019-12-09.
• 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

NCT03382262 is a completed randomized, open-label, parallel-group Phase 2 study of FX006 32 mg versus TAcs 40 mg, each given as a single intra-articular injection. It enrolled 55 patients with shoulder or hip osteoarthritis. The primary endpoint was triamcinolone acetonide concentration in blood plasma, summarized as a geometric mean with a 95% confidence interval over a 12 Weeks timeframe.

The registry describes scheduled pharmacokinetic sampling and rules for handling BLOQ values. It reports that 50 of 55 patients were included in the primary analysis population and identifies hip-index exclusions related to investigational product administration deviations. The description of those exclusions is incomplete.

Numerical primary endpoint results and analyses are not reported in the registry record. Safety entries list zero serious adverse events and zero deaths in each treatment-by-joint group, alongside counts of other adverse events. The record does not report enough detail to interpret those other events or estimate comparative risk.