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 in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety (NCT01712178), a randomized phase 2 study. The primary outcome is Serum Concentrations of Adalimumab at Weeks 12 and 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01712178 |
| Phase | Phase 2 |
| Condition | Rheumatoid Arthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
| Results posted | Yes |
2. Clinical Question
Population
Participants with active rheumatoid arthritis were studied. The registry record lists an enrollment of 100 and describes serum concentration analyses using data from participants in both formulation groups. The number analyzed differs by group and time point, but the record does not explain why.
Intervention
The intervention was the new formulation of adalimumab, administered at 40 mg every other week.
Comparator
The comparator was the current formulation of adalimumab, also administered at 40 mg every other week.
Primary question
The primary outcome was mean serum adalimumab concentration, measured at Weeks 12 and 24. The registry record does not report the group means or a numerical comparison between the formulations.
The central statistical question is whether the measured serum concentrations differed between the formulation groups at the specified follow-up times. Concentration is a pharmacokinetic measure: it describes the amount of drug measured in serum. The record also lists pharmacodynamic, safety, immunogenicity, and patient-reported outcomes as secondary outcomes.
Because the primary outcome is reported at more than one time point, interpreting it requires attention to both the measurements and the way comparisons were planned. The registry record does not report a primary-outcome estimate, uncertainty interval, or test result, and does not specify how the measurements at the two times were combined or interpreted together. The record therefore establishes the question and outcome definition, but does not support a numerical conclusion about whether the formulations had similar or different serum concentrations.
3. Trial Design
This was a randomized, double-masked, parallel-group phase 2 study in rheumatoid arthritis. Its listed title describes comparison of two adalimumab formulations for pharmacokinetic, pharmacodynamic, and safety outcomes. The registry record lists enrollment of 100 and status as completed. The study start is recorded as 2012-06, with primary completion in 2013-05.
Participants were assigned to receive either the new or current formulation. Both arm descriptions specify adalimumab 40 mg every other week. A parallel-group design compares groups followed under their assigned interventions, rather than comparing the same participant under both formulations. Random allocation is intended, in general, to reduce systematic differences between groups at the start of a trial. The registry record does not report the allocation procedure or describe how the double masking was implemented.
The primary outcome was serum concentration of adalimumab at Weeks 12 and 24. The record says blood samples were collected by venipuncture and concentrations were determined using a validated enzyme-linked immunosorbent assay (ELISA). It describes the outcome statistic as a mean with standard deviation. For the new formulation, the analyzed data were from 46 participants at Week 12 and 47 at Week 24. For the current formulation, data were analyzed from 43 participants at Week 12 and 41 at Week 24.
The registry record lists nine outcome measures and names additional outcomes involving ACR responses, HAQ-DI, SF-36, anti-adalimumab antibodies, adverse events, and injection-site pain. It does not report the numerical results for these outcomes in the registry record for this analysis. The record also does not state the sample-size justification, details of the randomization sequence, masking procedures, or statistical analysis plan. Those details should not be inferred from the design labels alone.
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 | New Formulation of Adalimumab 40 mg Every Other Week | Current Formulation Adalimumab 40 mg Every Other Week |
|---|---|---|
| STARTED | 50 | 50 |
| COMPLETED | 49 | 47 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | New Formulation of Adalimumab 40 mg Every Other Week | Current Formulation Adalimumab 40 mg Every Other Week |
|---|---|---|
| Withdrew consent due to an adverse event | 1 | 1 |
| Serious adverse event/withdrew consent | 0 | 1 |
| Lost to Follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.
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 | New Formulation of Adalimumab 40 mg Every Other Week | Current Formulation Adalimumab 40 mg Every Other Week | Total |
|---|---|---|---|---|
| Participants analysed | 50 | 50 | 100 | |
| Age, Continuous | years | 55.5 (SD 11.0) | 53.0 (SD 12.3) | 54.3 (SD 11.6) |
| Sex: Female, Male: Female | Participants | 41 | 41 | 82 |
| Sex: Female, Male: Male | Participants | 9 | 9 | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Serum Concentrations of Adalimumab at Weeks 12 and 24, measured over Measured at Weeks 12 and 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | µg/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint measures the concentration of adalimumab in serum at Weeks 12 and 24. Serum concentration is a pharmacokinetic measure: it describes the amount of drug detected in a blood-derived sample at a specified time. The record states that blood was collected by venipuncture and that concentration was measured with a validated ELISA method. It specifies the mean and standard deviation as the summary statistics.
In general, a concentration measure can help characterize drug exposure. Comparing group-level concentrations can describe whether the formulations are associated with different measured exposure at the specified assessment times. The endpoint is not itself a direct measure of symptom improvement or disease control. The registry record separately lists clinical response and other patient measures among the secondary outcomes.
For the primary outcome, the record reports the number of participants whose data were analyzed at each time point: 46 and 47 for the new formulation at Weeks 12 and 24, respectively, and 43 and 41 for the current formulation at those times. It does not report the corresponding means, standard deviations, group differences, or uncertainty intervals. It also does not describe a rule for combining the time points into a single result. As a result, the endpoint definition and analysis counts are available, but the actual concentration findings and their precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies serum adalimumab concentration at Weeks 12 and 24 as the primary outcome and describes the outcome as a mean with standard deviation. It also gives the number of participants whose data were analyzed at each time point. However, it does not report the concentration means, standard deviations, between-group estimates, confidence intervals, or p-values. The primary comparison therefore cannot be interpreted quantitatively from the record.
In general, an estimate of a difference between groups describes the direction and size of an observed contrast, while an uncertainty interval shows the range of values compatible with the data under the analysis assumptions. Neither kind of numerical result is reported for the primary outcome. The absence of those results does not establish that the groups had the same concentrations, nor does it establish that they differed. It means the registry record does not provide the information needed to assess the comparison’s magnitude or precision.
The analyzed counts are not identical across time points or formulation groups. The record does not explain the reasons for these counts, describe participant flow, or state how unavailable measurements were handled. Counts alone cannot show whether the analyzed participants were representative of all assigned participants, or whether missing measurements could have affected the comparison.
The listed secondary outcomes include clinical response measures at Weeks 12 and 24, health-status measures, antibody positivity, adverse events, and injection-site pain. Their inclusion describes what the study intended to assess, but without numerical results it does not establish what the study observed for those outcomes. The registry record reports safety counts for serious and other adverse events, but those counts are descriptive and do not replace the missing primary-outcome estimates.
Accordingly, the appropriate reading is limited: this was a randomized comparison of two formulations, with the same listed dose and schedule, and the primary endpoint was serum concentration at specified follow-up times. The registry record does not provide the results required to determine how the groups compared on that endpoint. It also does not report an analysis plan or multiplicity procedure that would clarify how the several outcomes and time points were handled inferentially.
9. Statistical Methods Explained
The trial is described as randomized, double-masked, and parallel-group. In general, random allocation helps make treatment groups comparable in expectation by assigning interventions through a chance-based process. It does not guarantee that groups will be identical in every characteristic, particularly in a study of limited size. The registry record gives the design label but does not report the sequence-generation method, allocation concealment procedure, or other implementation details.
Double masking generally means that more than one relevant party is kept unaware of assigned treatment, which can reduce the influence of expectations on care, reporting, or assessment. The registry record does not identify which people were masked or explain how the formulations were made indistinguishable. Therefore, the label describes the stated design but not its operational details.
The primary endpoint is continuous: it is a serum concentration measured in µg/mL. The registry record identifies the mean as the summary measure and standard deviation as the measure of dispersion. In general, the mean describes the central level of observed values, while the standard deviation describes how spread out individual measurements are around that mean. Neither statistic is reported numerically for either formulation at either assessment time.
Means and standard deviations provide descriptive summaries, but they do not by themselves communicate the precision of a between-group comparison. In general, a confidence interval for a contrast conveys uncertainty around the estimated difference, with its width influenced by variability and the amount of information available. A p-value addresses compatibility with a specified null model under the analysis assumptions; it does not measure the size or clinical importance of an effect. The registry record does not report confidence intervals, p-values, or a numerical contrast for the primary endpoint.
The outcome was measured at Weeks 12 and 24. Repeated measurements can be analyzed separately at each time, or with a model that accounts for measurements from the same participant. These approaches answer related but not necessarily identical questions and rely on different analysis choices. The registry record does not state whether the times were analyzed separately, jointly, or according to another prespecified method. It also does not report whether the analysis adjusted for baseline concentration or other covariates.
The record says serum concentrations were determined using a validated ELISA method. Laboratory validation is intended to establish that an assay performs adequately for its measurement purpose. It does not, by itself, describe the accuracy of every individual measurement or resolve issues such as sample handling, assay variability, or analysis decisions. Those procedural details are not reported in the registry record.
Unequal analyzed counts across groups and times require care in interpretation. In general, missing measurements can reduce precision and can bias a comparison if the chance of a measurement being unavailable is related to treatment or outcome. The counts reported for this study do not identify why data were unavailable or establish the assumptions used to address them. The record does not report imputation, a missing-data model, or sensitivity analyses.
The registry lists multiple outcome measures, and the primary outcome itself has two specified assessment times. When many outcomes or time points are examined, the chance of obtaining at least one apparently notable finding can increase if each is tested separately. General approaches to this issue include prespecifying a primary comparison, adjusting inference across tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or a hierarchy of tests. It also does not report the full statistical analysis plan, so the intended inferential framework cannot be reconstructed from the outcome list alone.
The sample-size assumptions describe planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. Such illustrations are conditional planning calculations, not results from the trial and not observed power. The registry record does not report the trial’s own sample-size justification. No numerical planning estimates are stated in the record details considered for this explanation.
For the primary endpoint, the record’s status as a mean of a continuous measure is a description of the planned summary, not evidence that a particular statistical test was used. The analysis method, assumptions, and treatment of repeated measurements remain unreported. Without the observed group summaries and the analysis method, readers cannot independently reproduce or assess the primary comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several outcomes, including ACR 20 and ACR 50 responses, HAQ-DI scores, SF-36 component scores, anti-adalimumab antibody positivity, adverse events, and injection-site pain. The primary serum concentration outcome is measured at Weeks 12 and 24. Considering multiple outcomes and time points can create multiplicity: in general, the more separate comparisons that are made, the greater the chance that some may appear notable by chance. The record does not report a multiplicity adjustment, a testing hierarchy, or which secondary outcomes were intended to be confirmatory.
The record reports analyzed counts for the primary endpoint by formulation and time point. It does not state whether the analysis included all randomized participants, all participants who received treatment, or another defined population. It does not report the handling of missing measurements, withdrawals, or protocol deviations, and it does not identify an intention-to-treat or per-protocol analysis. The analyzed counts alone do not establish which participants were included under a particular analysis-population definition.
In general, missing outcome data may affect both precision and validity, depending on why the data are missing and how the analysis handles them. The registry record does not describe the reasons for the differing analyzed counts, the assumptions used about missingness, or any sensitivity analysis. Consequently, the potential effect of missing data on the primary comparison cannot be evaluated from the record.
The number of outcome measures listed is nine, but the registry record does not provide the statistical analysis plan or numerical results for the outcomes. It therefore does not permit assessment of how multiplicity or missing data influenced the reported findings.
11. 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 |
|---|---|---|---|
| New Formulation of Adalimumab 40 mg Every Other Week | 0 | 50 | 0.0% |
| Current Formulation Adalimumab 40 mg Every Other Week | 2 | 50 | 4.0% |
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 |
|---|---|
| New Formulation of Adalimumab 40 mg Every Other Week | 23 of 50 |
| Current Formulation Adalimumab 40 mg Every Other Week | 16 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | New Formulation of Adalimumab 40 mg Every Other Week | Current Formulation Adalimumab 40 mg Every Other Week |
|---|---|---|---|
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | 0 of 50 | 1 of 50 |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 50 | 1 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | New Formulation of Adalimumab 40 mg Every Other Week | Current Formulation Adalimumab 40 mg Every Other Week |
|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | 5 of 50 | 6 of 50 |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 4 of 50 | 4 of 50 |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | 3 of 50 | 4 of 50 |
| CYSTITIS | Infections and infestations | 4 of 50 | 2 of 50 |
| DYSPEPSIA | Gastrointestinal disorders | 3 of 50 | 1 of 50 |
| NAUSEA | Gastrointestinal disorders | 4 of 50 | 0 of 50 |
| SINUSITIS | Infections and infestations | 3 of 50 | 1 of 50 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 3 of 50 | 1 of 50 |
| INJECTION SITE REACTION | General disorders | 3 of 50 | 0 of 50 |
Serious events with the highest arm-level rate: thoracic vertebral fracture (2.0%), transitional cell carcinoma (2.0%).
The safety record lists 50 participants at risk in each formulation group. It reports 0 participants with serious adverse events in the new-formulation group and 2 in the current-formulation group. For other adverse events, the listed counts are 23 and 16, respectively. These are descriptive counts; the registry record does not report a statistical comparison, uncertainty interval, or adjustment for differences in exposure or follow-up.
The registry record lists thoracic vertebral fracture and transitional cell carcinoma as serious adverse-event terms, each at 2.0%. The entries do not identify which formulation group each term belongs to, so group-specific attribution should not be inferred from those percentages. Death counts are not reported in the registry record.
In general, adverse-event counts describe events recorded under the study’s definitions and observation procedures. A count alone does not establish that an event was caused by treatment, and a difference in counts does not by itself establish a reliable difference in risk. The record does not provide further information on event definitions, severity grading, exposure duration, or adjudication. These figures should therefore be read as the reported safety counts, not as proof of a causal effect or a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
This trial record documents a randomized, double-masked comparison of new and current adalimumab formulations in rheumatoid arthritis. The arms are described as receiving 40 mg every other week. Its primary outcome is serum adalimumab concentration at Weeks 12 and 24, a pharmacokinetic measure intended to characterize drug levels. The record also lists clinical response, health-status, immunogenicity, and safety outcomes.
The registry record does not report the numerical primary-outcome results. There are no group means, standard deviations, between-group estimates, confidence intervals, or p-values in the information available for this analysis. Therefore, the record cannot establish whether measured concentrations were similar or different, nor how precise a comparison would be. The missing numerical results should not be interpreted as evidence of no difference or evidence of a difference.
The design labels describe the stated structure of the trial, but do not provide the detailed randomization or masking procedures. The analyzed participant counts are reported for each primary time point, but the reasons for the differing counts and the handling of missing data are not. The registry record also does not report the statistical analysis plan or how inference across outcomes and time points was managed.
The safety counts offer a limited descriptive account: serious and other adverse events are listed for both groups, and two serious-event terms are reported with percentages. These figures do not on their own establish causation or provide a complete comparison of safety. The record does not provide the contextual details needed to assess the events beyond the listed counts and terms.
In general, a clinical trial’s design and endpoint definitions indicate what investigators set out to compare; numerical estimates and their uncertainty are needed to evaluate the observed comparison. Here, the registry record describes the question and some safety counts, but leaves the primary concentration findings and important analysis details unreported. Conclusions about comparative pharmacokinetic findings cannot be drawn from the record alone.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between defining an endpoint and reporting its result. The registry record specifies serum concentration as the primary outcome, gives the measurement method, identifies the summary statistic, and states the assessment times. Those details clarify what was intended to be measured. They do not show the observed values or the precision of the comparison, which are essential for interpreting the primary question.
The endpoint is repeated across Weeks 12 and 24, so the analysis must account for how those assessments relate to the study question. Separate comparisons at each time point and a joint analysis can yield different summaries and inferential conclusions. The registry record does not state which approach was used. This illustrates why outcome definitions and analysis methods both matter when interpreting longitudinal trial data.
The listed analyzed counts also highlight the need to describe analysis populations and missing data. Counts vary across groups and time points, but the record does not explain why. In general, clear reporting of participant flow, missingness, and analysis populations allows readers to assess how much information contributes to an estimate and whether exclusions could affect its interpretation.
Finally, the study includes multiple secondary outcomes alongside a primary outcome measured at two times. Prespecification and transparent reporting of multiplicity procedures help readers distinguish a central confirmatory comparison from other analyses. The registry record does not report such procedures. Without the primary numerical results and analysis details, the statistical contribution of this trial cannot be judged by its design description alone.
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 the primary outcome is that its numerical results are not reported in the registry record. Although the endpoint definition, assay description, analysis counts, and summary-statistic type are stated, the means and standard deviations are absent. There is also no reported between-group estimate, confidence interval, or p-value. The magnitude and precision of the primary comparison therefore cannot be assessed.
The record does not report the statistical analysis plan, including the method for handling the two measurement times, any covariate adjustment, or the approach to missing data. It gives different analyzed counts by formulation and time point but does not explain the differences. The analysis population and participant flow are not specified in the registry record for this analysis.
Details of the randomization process and masking implementation are also not reported. The design labels alone do not show how allocation was generated or concealed, or which parties were masked. The registry record does not report a sample-size justification or explain how the enrollment target was selected. Planning illustrations based on observed effects are not a substitute for the trial’s own design rationale.
Several secondary outcomes and multiple assessment times are listed, but the record does not describe a multiplicity strategy or provide their numerical results. Safety information is limited to listed counts and serious-event terms, without group attribution for the terms in the record entries or additional details on event definitions and follow-up. These omissions limit interpretation of both the primary comparison and the broader outcome profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety — NCT01712178.
- Registry record last updated 2014-06-11; status last verified 2014-06.
- Results first posted 2014-06-11.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01712178 is a completed phase 2 randomized, double-masked, parallel-group study in rheumatoid arthritis. The registry record lists enrollment of 100, a start of 2012-06, and primary completion in 2013-05. The comparison was between new and current adalimumab formulations, each described as 40 mg every other week.
The primary outcome was mean serum adalimumab concentration, with standard deviation, at Weeks 12 and 24. The record describes venipuncture and a validated ELISA method and reports the analyzed counts by group and time. It does not report the numerical concentration results or a statistical comparison.
Listed secondary outcomes include clinical response, health-status measures, antibodies, adverse events, and injection-site pain. Safety counts are reported, but analysis details, missing-data methods, multiplicity procedures, and the trial’s sample-size justification are not reported in the registry record.