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 to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (NCT02405780), a randomized phase 3 study. The primary outcome is Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02405780 |
| Phase | Phase 3 |
| Condition | Arthritis, Rheumatoid |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 645 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fujifilm Kyowa Kirin Biologics Co., Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with rheumatoid arthritis who had completed study FKB327-002 and had inadequate disease control on methotrexate. The official title also specifies concomitant methotrexate. The registry lists an enrollment of 645, while the safety groups have their own at-risk counts.
Intervention
FKB327, given as a 40 mg subcutaneous injection every other week. The treatment period could continue for 76 weeks, according to the arm description.
Comparator
Humira®, also given as a 40 mg subcutaneous injection every other week, with a treatment period that could continue for 76 weeks.
Primary question
How many patients in each treatment group experienced adverse events during Period I, defined as Week 0 up until Week 30? The posted primary outcome is a safety count. The record does not report a single comparative estimate, confidence interval, or p-value for this outcome.
The study was intended to compare long-term safety, efficacy, and immunogenicity, with pharmacokinetics also included in the official title. The listed secondary efficacy outcomes include changes in DAS28 CRP and ACR20, ACR50, and ACR70 response rates. The registry record does not report results for those outcomes in the registry record for this analysis.
This question concerns a selected extension-study population, not all people with rheumatoid arthritis. Participants had completed the preceding study and had inadequate disease control on methotrexate. That context matters when considering whom the findings might describe. The registry record does not report further details about eligibility criteria or the preceding study's treatment experience.
3. Trial Design
This was a Phase 3, randomized, open-label, parallel-group study. It is described as an extension study for patients who had completed study FKB327-002. The registry lists the study as completed, with a start date of 2015-06-10 and a primary completion date of 2018-01-18.
Participants were assigned to FKB327 or Humira®. Both arm descriptions specify a 40 mg subcutaneous injection every other week, with treatment potentially continuing for 76 weeks. The registry identifies methotrexate as concomitant therapy in the official title and describes the target population as having inadequate disease control on methotrexate.
Random allocation can help balance prognostic factors between groups on average, although it does not guarantee balance in every realized trial. The registry record does not report the allocation ratio, sequence-generation procedure, concealment method, or stratification factors. Those details should not be inferred from the fact that allocation was randomized.
The study had no masking. In an open-label design, participants and investigators know which treatment is being received. That can affect some aspects of care, event reporting, or assessment, depending on the outcome and how it is collected. The record says investigators actively asked about adverse events and that participants could also report events spontaneously during or between clinic visits. It does not report whether any outcome assessment was independently blinded.
The primary safety outcome concerned Period I, from Week 0 up until Week 30. The arm descriptions allow treatment for as long as 76 weeks, so the primary safety window is not the full potential treatment period described for the study. The registry record does not provide a full schedule of study visits or explain the analysis of later follow-up. The enrollment listing and the at-risk counts in the posted safety results are distinct record items; the record does not explain their relationship.
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.
Period I
| Stage | FKB327-FKB327-FKB327 | FKB327-Humira-FKB327 | Humira-FKB327-FKB327 | Humira-Humira-FKB327 |
|---|---|---|---|---|
| STARTED | 216 | 108 | 108 | 213 |
| COMPLETED | 189 | 100 | 93 | 190 |
| NOT COMPLETED | 27 | 8 | 15 | 23 |
Reasons for not completing this period:
| Reason | FKB327-FKB327-FKB327 | FKB327-Humira-FKB327 | Humira-FKB327-FKB327 | Humira-Humira-FKB327 |
|---|---|---|---|---|
| Adverse Event | 8 | 0 | 3 | 7 |
| Medical reasons | 1 | 1 | 0 | 1 |
| Screening Failure | 1 | 0 | 1 | 0 |
| Withdrawal by Subject | 9 | 1 | 3 | 4 |
| Non-compliance with study procedures | 8 | 6 | 8 | 11 |
Period II
| Stage | FKB327-FKB327-FKB327 | FKB327-Humira-FKB327 | Humira-FKB327-FKB327 | Humira-Humira-FKB327 |
|---|---|---|---|---|
| STARTED | 189 | 100 | 93 | 190 |
| COMPLETED | 174 | 88 | 81 | 172 |
| NOT COMPLETED | 15 | 12 | 12 | 18 |
Reasons for not completing this period:
| Reason | FKB327-FKB327-FKB327 | FKB327-Humira-FKB327 | Humira-FKB327-FKB327 | Humira-Humira-FKB327 |
|---|---|---|---|---|
| Adverse Event | 3 | 5 | 4 | 11 |
| Medical reason | 0 | 1 | 0 | 0 |
| Pregnancy | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 7 | 4 | 0 | 3 |
| Non-compliance with study procedures | 5 | 2 | 7 | 4 |
Analysis population for the primary outcome, as defined in the registry: Each patient was counted once within each System Organ Class (SOC) and Preferred Term (PT). A patient may have had multiple events counted. Treatment Emergen Adverse Events (TEAE) defined as AEs that started or increased in severity after the first study dose and counted under the treatment arm.
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 | FKB327-FKB327 | FKB327-Humira | Humira-FKB327 | Humira-Humira | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 216 | 108 | 108 | 213 | 645 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 183 | 92 | 96 | 169 | 540 |
| Age, Categorical: >=65 years | Participants | 33 | 16 | 12 | 44 | 105 |
| Sex: Female, Male: Female | Participants | 162 | 85 | 83 | 171 | 501 |
| Sex: Female, Male: Male | Participants | 54 | 23 | 25 | 42 | 144 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 | 2 | 6 |
| Race (NIH/OMB): White | Participants | 187 | 90 | 90 | 185 | 552 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 26 | 17 | 15 | 25 | 83 |
| Region of Enrollment: Canada | Participants | 1 | 1 | 1 | 2 | 5 |
| Region of Enrollment: Chile | Participants | 13 | 7 | 6 | 14 | 40 |
| Region of Enrollment: Czechia | Participants | 22 | 9 | 11 | 22 | 64 |
| Region of Enrollment: Germany | Participants | 7 | 4 | 3 | 8 | 22 |
| Region of Enrollment: Peru | Participants | 26 | 17 | 15 | 26 | 84 |
| Region of Enrollment: Poland | Participants | 41 | 22 | 22 | 39 | 124 |
| Region of Enrollment: Romania | Participants | 8 | 4 | 3 | 8 | 23 |
| Region of Enrollment: Russia | Participants | 33 | 18 | 16 | 29 | 96 |
| Region of Enrollment: Spain | Participants | 2 | 1 | 2 | 4 | 9 |
| Region of Enrollment: Ukraine | Participants | 39 | 14 | 17 | 37 | 107 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I, measured over Period I: from Week 0 up until Week 30;.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the number of patients with adverse events, reported by treatment group for Period I, from Week 0 up until Week 30. The registry description says patients were monitored from informed consent until Week 30, with subsequent monitoring during Period II. For participants who discontinued early, a follow-up period of 4 weeks was added to the Early Termination Visit.
Adverse-event monitoring is used to characterize safety during treatment. It can capture events that arise or worsen after treatment begins, rather than restricting attention to a specific efficacy response. The registry describes treatment-emergent adverse events as events that started or increased in severity after the first study dose and were counted under the treatment arm.
The record also says that each patient was counted once within each System Organ Class and Preferred Term, while one patient could contribute to multiple event categories. This distinction matters: counts across categories need not represent separate people, and category counts should not be added to create a total number of affected patients. The outcome title refers to patients with adverse events, but the registry record does not give one overall patient-level comparative estimate for that outcome in the registry record for this analysis.
Safety counts are useful descriptive measures, but by themselves they do not show how precisely the groups differ or establish that a difference is attributable to treatment. A confidence interval, when reported, conveys the range of effect sizes compatible with the data under the analysis assumptions. No such comparative interval is reported in the registry record for this primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures list 43 serious adverse events affected in the FKB327 group, with 614 at risk, and 14 in the Humira® group, with 321 at risk. The registry also lists other adverse-event counts of 125 and 46, respectively, with the same group-specific at-risk counts. These are the reported group figures; no between-group effect estimate should be inferred from them without a specified analysis.
The registry lists 3 deaths in the FKB327 group and 1 in the Humira® group. It does not provide, in the registry record, a comparative analysis of deaths or a cause-specific interpretation. The counts should therefore be read as descriptive registry entries rather than as evidence that treatment caused or prevented an outcome.
The serious adverse-event terms listed include Pneumonia and Pyelonephritis acute, each reported as 0.7%; Acute myocardial infarction, Pyelonephritis, Sepsis, and Back pain are each reported as 0.3%. The record does not provide further detail in the registry record about the number of events for each listed term, the groups in which they occurred, or a comparison between treatments. These listed percentages should not be combined or treated as a comparative measure.
The primary outcome has multiple categories or time points and was not reduced to one comparison in the posted analysis. The registry reports 15 outcome measures and 0 analyses. It does not report a primary-outcome p-value, confidence interval, or adjusted estimate in the registry record for this analysis. Consequently, the counts do not establish whether the groups differ beyond what could reasonably arise from sampling variability.
Differences in group size and follow-up exposure can affect the interpretation of raw counts. A count is not a rate or a risk comparison, and no new rates or ratios are calculated. Even a group-specific proportion would not substitute for a prespecified comparative analysis that addresses the study design, outcome definition, and any incomplete follow-up.
The randomized design is relevant to causal interpretation, but randomization alone is not enough to resolve all uncertainty. The study was open-label, and the registry does not report the detailed statistical analysis plan, how missing outcomes were handled, or whether analyses adjusted for any factors. These omissions limit what can be concluded from the posted safety counts. They do not imply a particular direction or size of treatment difference.
9. Statistical Methods Explained
Statistical interpretation begins with identifying what was measured, in whom, and over what time window. In this study, the primary outcome is a count of patients with adverse events by treatment group during Period I, defined as Week 0 up until Week 30. The registry describes treatment-emergent events as those that began or worsened after the first study dose. It also describes active questioning by investigators and spontaneous reports by participants.
What does randomization contribute?
In general, randomization assigns treatment using a chance-based process. Its purpose is to reduce systematic differences in measured and unmeasured baseline factors between groups. It supports a fair comparison when the assigned groups are analyzed appropriately, but it does not guarantee that the groups are identical, prevent loss to follow-up, or eliminate measurement bias. The registry identifies the study as randomized but does not report the allocation procedure, allocation ratio, concealment, or stratification details.
The design was parallel-group, meaning the registry describes separate treatment arms rather than a crossover comparison. It was open-label, so treatment assignment was not masked. As a general matter, awareness of treatment can influence expectations, care, and reporting. That concern may be more relevant to outcomes requiring judgment or participant reporting than to outcomes with a highly objective definition. The record does not describe any blinded adjudication process.
How should event counts be understood?
A count records how many events or affected participants were recorded, according to the specific outcome definition. It is not automatically a risk, rate, or treatment effect. A risk comparison ordinarily needs clearly defined denominators and consistent follow-up; a rate comparison also needs time-at-risk information. The registry supplies group counts and at-risk counts for the safety entries, but the registry entries do not report a modeled comparison, a time-adjusted analysis, or a confidence interval.
The registry notes that a patient could be counted once within each System Organ Class and Preferred Term and could have multiple events counted. This means categories can overlap at the participant level. In general, summing category counts can count the same person more than once, so category totals should not be interpreted as the number of unique patients. The record does not report an overall patient-level adverse-event comparison in a form that permits a single treatment-effect estimate.
What do confidence intervals and p-values add?
In general, a confidence interval describes statistical uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates greater uncertainty. Whether an interval includes a null value is not, on its own, a complete assessment of clinical importance or study quality. A p-value measures how incompatible the observed data are with a specified null model, conditional on the assumptions used; it is not the probability that the null hypothesis is true.
The registry record does not report a confidence interval or p-value for the primary safety comparison in the registry record for this analysis. It also does not report an adjusted or unadjusted comparative estimate. Therefore, the descriptive counts do not support a conclusion about statistical significance or the precision of a treatment contrast.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can arise when event counts vary more across participants or clusters than a simple model allows. If a model ignores this extra variation, uncertainty can be understated and intervals may be too narrow. The registry record does not identify a count model or report whether over-dispersion was assessed. This is a general consideration, not a claim about the analysis used in this study.
What does the planning illustration represent?
In general, a sample-size calculation asks how many participants would be needed to detect a specified effect under stated assumptions about significance level, allocation, and statistical method. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not evidence of the original trial's design rationale. The registry record does not report the trial's own sample-size justification, and sample-size illustrations are not observed power.
The listed analysis count is 0. The record does not report whether interim analyses were planned or performed, how the primary outcome was modeled, or how multiplicity and missing data were handled. Those omissions prevent a more specific reconstruction of the statistical methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures, including efficacy outcomes such as DAS28 CRP change and ACR20, ACR50, and ACR70 response rates. The primary outcome is a safety measure. The record does not report a multiplicity strategy, such as a testing hierarchy or adjustment across outcomes. Without that information, the extent to which any inferential results would account for multiple comparisons is not reported in the registry record.
The registry lists 0 analyses. The registry entries contain no primary-outcome comparative estimate, p-value, or confidence interval. They also do not specify an analysis population, such as an intention-to-treat or per-protocol population, for the posted results. The group-specific safety counts should not be assumed to come from a particular analysis set beyond the registry's stated at-risk counts.
Missing-data methods are not reported in the registry record. The record mentions monitoring after early discontinuation and a 4-week follow-up period for participants who discontinued early, but it does not explain how missing event information or incomplete follow-up was handled in analysis. In general, missing outcomes can affect estimates when their absence is related to treatment, health status, or the outcome itself. The direction and magnitude of any such effect cannot be determined from the registry entries.
The registry also does not report the statistical plan, any interim analyses, or whether outcome definitions and analysis choices were finalized before results were examined. These details matter for judging the reliability of inference, but their absence should not be filled by assumption. The record's descriptive safety figures remain interpretable as reported counts, with these analytic uncertainties kept in view.
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 |
|---|---|---|---|
| FKB327 | 43 | 614 | 7.0% |
| Humira® | 14 | 321 | 4.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| FKB327 | 3 of 614 |
| Humira® | 1 of 321 |
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 |
|---|---|
| FKB327 | 125 of 614 |
| Humira® | 46 of 321 |
Most frequent serious adverse event terms
| Event term | Organ system | FKB327 | Humira® |
|---|---|---|---|
| Pneumonia | Infections and infestations | 4 of 614 | 1 of 321 |
| Pyelonephritis acute | Infections and infestations | 4 of 614 | 1 of 321 |
| Acute myocardial infarction | Cardiac disorders | 2 of 614 | 0 of 321 |
| Bronchitis | Infections and infestations | 1 of 614 | 1 of 321 |
| Pyelonephritis | Infections and infestations | 2 of 614 | 0 of 321 |
| Sepsis | Infections and infestations | 2 of 614 | 0 of 321 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 614 | 0 of 321 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 1 of 614 | 1 of 321 |
| Cervical dysplasia | Reproductive system and breast disorders | 2 of 614 | 0 of 321 |
| Endometrial hyperplasia | Reproductive system and breast disorders | 1 of 614 | 1 of 321 |
Most frequent non-serious adverse event terms
| Event term | Organ system | FKB327 | Humira® |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 68 of 614 | 22 of 321 |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | 37 of 614 | 15 of 321 |
| Bronchitis | Infections and infestations | 32 of 614 | 14 of 321 |
Serious events with the highest arm-level rate: pneumonia (0.7%), pyelonephritis acute (0.7%), acute myocardial infarction (0.3%), pyelonephritis (0.3%), sepsis (0.3%).
The registry lists serious-event counts of 43 for FKB327 and 14 for Humira®, with at-risk counts of 614 and 321, respectively. It lists other adverse-event counts of 125 and 46, with the same group-specific at-risk counts. These are counts, not comparative effect estimates. No rates, ratios, risk differences, or confidence intervals are reported in the registry record for this analysis.
The record separately lists 3 deaths in the FKB327 group and 1 in the Humira® group. It does not provide details that establish whether these deaths were considered treatment-related, or a statistical comparison of death counts. They should not be interpreted as evidence of causation.
The listed serious-event terms and percentages are Pneumonia, 0.7%; Pyelonephritis acute, 0.7%; Acute myocardial infarction, 0.3%; Pyelonephritis, 0.3%; Sepsis, 0.3%; and Back pain, 0.3%. The registry record does not give further group-specific detail for these entries in the registry record.
In general, adverse-event categories can overlap because one participant may experience more than one type of event. The record explicitly says patients could be counted in multiple event categories. Consequently, category counts should not be added to estimate the number of affected participants.
12. What the Result Does, and Does Not, Mean
The posted results describe safety events recorded in a randomized, open-label extension study of FKB327 and Humira® among patients with rheumatoid arthritis who had completed study FKB327-002 and had inadequate disease control on methotrexate. They include group-specific serious and other adverse-event counts, deaths, and selected serious-event terms. They do not provide a formal comparative estimate for the primary safety outcome in the registry record for this analysis.
These figures do not establish that either treatment caused or prevented an event. Counts alone do not account for uncertainty, differences in follow-up, or the possibility that participants contributed to more than one event category. The registry record does not report the analysis needed to quantify a comparative effect or its precision. No conclusion about statistical significance can be drawn from the listed counts alone.
The study was randomized, which is a design feature intended to support fair comparisons, but it was also open-label. The registry does not report details of the allocation procedure, blinded assessment, missing-data handling, or the statistical analysis plan. These limitations affect how fully the results can be evaluated; they do not prove that any particular bias occurred.
The results also should not be generalized automatically to people outside the described extension population. Participants had completed the preceding study, and the registry describes inadequate disease control on methotrexate. The record does not provide further eligibility details in the registry record for this analysis.
The study's stated purpose included long-term safety, efficacy, and immunogenicity, while the official title also names pharmacokinetics. The registry entries do not report results for those broader objectives or for the listed secondary efficacy outcomes. The most defensible reading is therefore limited: the registry provides descriptive safety counts for the stated groups, while comparative effect size, precision, and broader outcome results are not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates why trial design and result reporting need to be read together. Randomized allocation is intended to strengthen treatment comparisons, while the open-label design can matter for outcomes influenced by reporting or assessment. Neither feature alone determines the reliability of a result; the outcome definition, follow-up, analysis, and uncertainty estimates also matter.
The primary outcome is a safety count over a defined period, not a single comparative treatment effect in the posted results. The registry also describes multiple adverse-event categories, with the possibility that the same patient could appear in more than one category. This makes careful distinction between event counts and participant counts essential. Category entries cannot be combined into a total number of affected people.
The record names long-term safety, efficacy, immunogenicity, and pharmacokinetics among the study objectives, and lists several secondary efficacy measures. Yet the registry entries do not include comparative results for those measures, nor a confidence interval or p-value for the primary safety comparison. This gap highlights a general statistical reporting principle: estimates and uncertainty are needed to judge the size and precision of a group difference, not merely event counts.
The extension-study setting also defines the scope of inference. The population had completed a preceding study and had inadequate disease control on methotrexate. That context is relevant when considering applicability beyond the participants described by the registry.
Finally, the record does not report its detailed analysis plan, multiplicity approach, missing-data method, or sample-size justification. These are central to evaluating how planned comparisons were conducted and how robust the conclusions may be. Their absence does not invalidate the descriptive record, but it limits the statistical conclusions that can be drawn from the information reported.
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 registry record does not report a comparative effect estimate, confidence interval, or p-value for the primary safety outcome in the registry record for this analysis. This prevents assessment of the magnitude and precision of any difference between treatment groups. The figures should therefore remain descriptive.
The outcome covers Period I, from Week 0 up until Week 30, while the treatment period could continue for 76 weeks. The registry entries do not provide a comparative analysis of safety over the full potential treatment period. The record describes follow-up during Period II and an additional 4-week follow-up for early discontinuations, but does not explain how the subsequent observations were analyzed.
The study is open-label. In general, knowledge of treatment assignment can influence reporting or assessment of adverse events, although the registry says investigators actively asked about events and participants could report them spontaneously. The record does not state whether event assessment was blinded or independently adjudicated.
The adverse-event description allows one patient to be counted in multiple System Organ Class or Preferred Term categories. Therefore, category counts are not necessarily counts of separate people. The record does not report enough detail to reconstruct a single overall patient-level comparison from the listed categories.
The extension population was made up of patients who had completed study FKB327-002 and had inadequate disease control on methotrexate. This selected context may limit applicability to populations with different treatment histories or characteristics; further eligibility details are not reported in the registry record.
Other important analysis details are not reported in the registry record, including the statistical analysis plan, analysis population, missing-data method, multiplicity strategy, allocation procedure, and the trial's sample-size justification. The study is listed as completed, but that status does not fill in these methodological details.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients — NCT02405780.
- Registry record last updated 2019-03-26; status last verified 2019-03.
- Results first posted 2019-03-26.
- 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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18. Record Summary
This Phase 3 study was a randomized, open-label, parallel-group extension comparing FKB327 with Humira® in patients with rheumatoid arthritis who had completed study FKB327-002 and had inadequate disease control on methotrexate. Both arms used a 40 mg subcutaneous injection every other week, with treatment potentially continuing for 76 weeks.
The primary outcome was the number of patients with adverse events in Period I, from Week 0 up until Week 30. The registry lists serious-event counts of 43 for FKB327 and 14 for Humira®, and other adverse-event counts of 125 and 46, respectively. The corresponding at-risk counts are 614 and 321. Deaths are listed as 3 and 1, respectively.
The registry lists 15 outcome measures and 0 analyses. A comparative primary-outcome estimate, confidence interval, p-value, detailed analysis plan, and missing-data method are not reported in the registry record in the registry record for this analysis. The posted safety figures are therefore descriptive and do not quantify the precision or cause of a difference between groups.