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 Extension in AS: Sustainability of Benefits, Safety and Tolerability (NCT01863732), a randomized phase 3 study. The primary outcome is Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01863732 |
| Phase | Phase 3 |
| Condition | Spondylitis, Ankylosing |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 274 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Participants with active ankylosing spondylitis who had taken part in the phase III core study CAIN457F2305 and enrolled in its extension. The extension Full Analysis Set is defined as all participants enrolled in the extension; enrollment was 274.
Intervention
Secukinumab (AIN457) in prefilled syringes for subcutaneous self-administration every four weeks. The extension descriptions include 75 mg and 150 mg regimens, as well as a 75 mg regimen that was up-titrated to 150 mg after unblinding.
Comparator
The listed groups include participants receiving placebo in the core study before receiving secukinumab in the extension, as well as a placebo group in the adverse-event record. A complete account of the comparator structure for the primary endpoint is not reported in the registry record.
Primary question
How sustainable were ASAS 20 responses during the extension period from Week 104 to Week 260 among enrolled participants? The registry record describes the endpoint but states that no statistical analysis was performed, so it does not give an estimated response result or a comparison between regimens.
This was an extension study intended to make secukinumab treatment available to participants from the core study and to generate additional information on long-term clinical benefits, safety, and tolerability. The primary endpoint concerns the proportion of participants meeting the ASAS 20 response definition across the specified extension period. It is not a single measurement of change in a continuous score: it classifies each participant according to whether the response criteria are met.
The extension included groups with different secukinumab doses and prior treatment histories. The listed descriptions distinguish participants who had received secukinumab in the core study from those who had received placebo there. They also describe dose schedules and later dose changes. The registry record does not provide an analyzed comparison that would establish how response differed between these groups. Its endpoint description says that participants who were up-titrated are counted only at their originally randomized treatment group.
Accordingly, the clinical question can be stated from the study aim and endpoint, but its numerical answer is not available in the posted primary outcome record. Response percentages, uncertainty intervals, and statistical tests are not reported in the registry record.
3. Trial Design
NCT01863732 is a completed phase III extension study titled “Extension in AS: Sustainability of Benefits, Safety and Tolerability.” Its official title describes an extension study evaluating the sustainability of clinical benefits, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis. The registry record lists randomized allocation, quadruple masking, and a parallel design. Enrollment was 274.
The study was intended for patients who had participated in the phase III core study CAIN457F2305. The brief summary describes the extension as a three-year study that made secukinumab in prefilled syringes available and aimed to generate additional long-term data. The registry record gives a start date of 2013-11-06 and a primary completion date of 2018-03-16. It lists the study status as completed.
The intervention descriptions identify secukinumab (AIN457) 75 mg and 150 mg regimens, delivered by subcutaneous self-administration every four weeks. Some descriptions include placebo alongside the active dose during the earlier extension period. They state that dosing changed after unblinding, including a 75 mg group that was up-titrated to 150 mg. Other listed groups had received placebo in the core study before entering a secukinumab extension group. These descriptions document the assigned regimens; they do not establish that every participant followed the entire schedule as planned.
The registry labels the design randomized and quadruple masked, but which roles were masked and the exact randomization procedures are not reported in the registry record. The primary outcome covers Week 104 to Week 260, and the extension Full Analysis Set is defined as all participants enrolled in the extension. The record does not report the number of participants contributing primary outcome data at each time point, the analysis populations used for other outcomes, or a statistical comparison among the dose or prior-treatment groups.
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.
Before assignment: Group 1: AIN457 75mg plus placebo 150mg dosed every 4 weeks from Wk 104E1 to Wk 152. At Wk 156 (after unblinding), only AIN457 75mg was dosed or up titrated to AIN457 150mg. Group 2: AIN457 150mg plus placebo 75mg dosed every 4 weeks from Wk 104E1 through Wk 152. At Wk 156 (after unblinding), only secukinumab 150 mg was dosed.
Overall Study
| Stage | Secukinumab (AIN457) 75mg Group 1 | Secukinumab (AIN457) 150mg Group 2 | Pbo in Core Then AIN457 75mg Group 1 | Pbo in Core Then AIN457 150mg Group 2 |
|---|---|---|---|---|
| STARTED | 100 | 87 | 46 | 41 |
| COMPLETED | 87 | 75 | 35 | 33 |
| NOT COMPLETED | 13 | 12 | 11 | 8 |
Reasons for not completing this period:
| Reason | Secukinumab (AIN457) 75mg Group 1 | Secukinumab (AIN457) 150mg Group 2 | Pbo in Core Then AIN457 75mg Group 1 | Pbo in Core Then AIN457 150mg Group 2 |
|---|---|---|---|---|
| Adverse Event | 2 | 0 | 3 | 3 |
| Lack of Efficacy | 1 | 0 | 2 | 1 |
| Lost to Follow-up | 2 | 2 | 1 | 1 |
| Physician Decision | 1 | 0 | 1 | 0 |
| Pregnancy | 0 | 0 | 0 | 1 |
| Technical problems | 0 | 1 | 1 | 0 |
| Subject/guardian decision | 6 | 9 | 3 | 1 |
| Death | 1 | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed
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 | Secukinumab (AIN457) 75mg Group 1 | Secukinumab (AIN457) 150mg Group 2 | Pbo in Core Then AIN457 75mg Group 1 | Pbo in Core Then AIN457 150mg Group 2 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 100 | 87 | 46 | 41 | 274 | |
| Age, Continuous | years | 42.5 (SD 13.37) | 38.2 (SD 11.58) | 43.0 (SD 13.00) | 42.5 (SD 12.13) | 41.2 (SD 12.68) |
| Sex: Female, Male: Female | Participants | 25 | 29 | 10 | 12 | 76 |
| Sex: Female, Male: Male | Participants | 75 | 58 | 36 | 29 | 198 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 7 | 1 | 1 | 12 |
| Race (NIH/OMB): Asian | Participants | 19 | 15 | 8 | 8 | 50 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 61 | 48 | 30 | 28 | 167 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 17 | 17 | 7 | 4 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260, measured over Week 104 to Week 260.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | % of responders |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 response from Week 104 to Week 260, expressed as a percentage of responders. The registry defines ASAS 20 as a validated composite assessment. A participant meets the response definition by achieving at least 20% improvement in at least 3 of 4 conventional clinical domains relevant to ankylosing spondylitis, with no worsening in the fourth domain.
This is a binary response classification at the participant level: each participant either meets the stated criteria or does not. The percentage summarizes the proportion classified as responders in the relevant analysis population and period. As a general statistical point, a composite response can capture improvement across several aspects of a condition while requiring that improvement not be offset by worsening in the remaining domain. The registry identifies the purpose of this endpoint as quantitatively assessing sustainability of clinical benefits during treatment.
The endpoint is not a direct measure of the size of change in each domain, nor does the definition alone show how many participants responded. The registry record gives no response counts or percentages, confidence interval, or test result for this outcome. It explicitly states that no statistical analysis was performed. Therefore, the endpoint’s definition and intended use are available, but its observed response result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry describes a primary endpoint but does not post an analyzed primary result. It reports ASAS 20 response as the proportion of responders from Week 104 to Week 260 and defines the response criteria. It also states that no statistical analysis was performed. There is consequently no posted response percentage, treatment contrast, confidence interval, or p-value from which to judge the magnitude or precision of an ASAS 20 finding.
The study’s stated objective was to assess the sustainability of clinical benefits over long-term secukinumab administration. That objective should not be mistaken for a reported finding. The presence of a long follow-up interval and a defined response measure does not, by itself, demonstrate that responses were maintained. A numerical summary of outcomes across the interval, along with the number of participants contributing information at each time point, would be needed to describe the posted results. Such information is not reported in the registry record.
The record names multiple treatment histories and dose regimens. It says that up-titrated participants are counted only in their originally randomized treatment group for the primary outcome description. This is relevant to understanding the intended group assignment for that endpoint, but does not supply the group-specific response results or establish whether an adjusted comparison was planned. Details of any statistical model or inferential procedure are not reported in the registry record.
General statistical interpretation: a response percentage is an estimate of the proportion meeting a defined criterion in a particular population and time frame. A confidence interval, when reported, describes uncertainty around that estimate under the method used; it does not resolve concerns about missing outcome data, selection into an extension, or the relevance of the analyzed population. No confidence interval is posted for the primary outcome, so its precision cannot be assessed from this record.
The adverse-event record does contain affected-participant counts for serious and other adverse events, and it reports deaths in each listed group. Those figures are descriptive safety information, not an analysis of the primary efficacy endpoint. The record does not provide inferential comparisons for these counts. Differences in exposure or follow-up between groups, if any, are not characterized in the posted information, so the counts should not be read as comparative event rates or as evidence of causation.
In short, the registry supports a description of the design, endpoint definition, and selected safety counts. It does not support a quantitative conclusion about the primary response outcome or a statistical comparison of the listed regimens.
9. Statistical Methods Explained
The registry identifies this study as randomized, quadruple masked, and parallel, and defines the primary outcome population as the Extension Full Analysis Set, consisting of all participants enrolled in the extension. However, it states that no statistical analysis was performed for the primary outcome. It does not report an analysis model, a hypothesis test, a confidence interval method, or a procedure for handling missing primary outcome data. The methods discussion therefore distinguishes the information recorded from general statistical concepts; it cannot reconstruct an unreported analysis.
What does a binary response measure?
The primary outcome is a percentage of responders. Each participant is classified according to whether the ASAS 20 criteria are met. In general, a percentage is calculated from the number of participants meeting a response definition relative to the relevant analysis denominator. The posted record does not provide those response counts or denominators for the primary endpoint, so no response percentage can be described from it.
Binary outcomes are straightforward to interpret when the response definition and analysis population are clear. They can also omit detail: participants just meeting the threshold and participants with larger improvement are both counted as responders. Conversely, a participant who does not meet the threshold is counted as a non-responder even if some individual domains improved. These are general properties of threshold-based outcomes, not additional findings from this study.
What would a confidence interval add?
General explanation: a confidence interval gives a range of values compatible with the observed data under a specified statistical method. Its width reflects uncertainty, including the amount of information and the variability in the data. For a response percentage or difference between groups, an interval can help distinguish a relatively precise estimate from one that remains uncertain. The registry record reports no primary outcome confidence interval, so the precision of any ASAS 20 response estimate cannot be evaluated.
What does randomization contribute?
In general, random assignment can help make groups comparable at the time of assignment by distributing measured and unmeasured characteristics without systematic selection. It does not guarantee balance in every realized study, and it does not automatically address missing outcomes or changes in treatment over time. The registry identifies randomized allocation and states that participants who were up-titrated are counted in their originally randomized treatment group for the primary endpoint. The randomization method, allocation concealment details, and group-specific primary results are not reported in the registry record.
The extension setting also matters when interpreting general trial methods. Participants had taken part in a core study before entering the extension, and some extension groups are described by their core-study treatment history. Outcomes among extension enrollees do not automatically describe everyone who could have entered the original core study. The registry does not report the characteristics of participants who did not enroll in the extension or a comparison of enrollees with non-enrollees.
Why can over-dispersion matter?
General explanation: over-dispersion occurs when observed variation in data is greater than a statistical model assumes. If a model underestimates that variation, its standard errors can be too small and its confidence intervals or tests can appear more certain than warranted. This concept is often relevant to count outcomes, but the primary endpoint is described as a binary percentage, and the registry record does not report an analysis model or a finding of over-dispersion. It would not be appropriate to claim that over-dispersion was assessed or affected this study’s results.
What do the sample-size illustrations mean?
General explanation: a planning illustration asks how many participants might be required under specified assumptions to detect a chosen effect with a specified power and significance level. It is not an observed result, and it is not observed power. The record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. The numerical effect and resulting participant counts are not reported in the registry record. These assumptions cannot be treated as the trial’s own design justification; that justification is not reported in the registry record.
The registry record states that the primary outcome had no statistical analysis and lists zero analyses. It therefore offers no basis for a recalculated treatment comparison. A recalculation from summary statistics would require posted outcome summaries, which are not reported. Any estimate, test result, or sample-size count beyond the stated planning assumptions would be unsupported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists ASAS 20 as the primary outcome and ASAS 40 response from Week 104 to Week 260 as a secondary outcome. The primary description also refers to assessment over a period spanning multiple time points. The registry flags that the primary outcome has several categories or time points and is not reduced to one comparison. It does not post a single primary comparison or a statistical analysis of the outcome.
When a study evaluates multiple outcomes, time points, groups, or comparisons, the chance of at least one apparently notable result can increase if each is tested independently. General approaches to multiplicity include defining a primary comparison in advance, adjusting inference across tests, or interpreting results as exploratory. Which approach, if any, was specified for this study is not reported in the registry record. No multiplicity adjustment or testing hierarchy is reported.
The record defines the Extension Full Analysis Set as all participants enrolled in the extension. It does not provide the number with observed ASAS 20 data at each time point, the number who discontinued, or the handling of missing measurements. Methods such as imputation, carrying forward a prior value, or classifying missing outcomes as non-response are not reported in the registry record and should not be assumed.
The extension descriptions state that participants who were up-titrated are counted only in their originally randomized treatment group for the primary endpoint. This gives one detail about group attribution, but it does not describe how treatment changes, discontinuation, or incomplete follow-up were handled analytically. The statistical plan, including any planned interim analyses, is not reported in the registry record. Without outcome denominators and missing-data methods, the completeness of follow-up and the potential sensitivity of the response summary to missing observations cannot be assessed.
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 |
|---|---|---|---|
| Any Secukinumab (AIN457) 75 mg | 36 | 179 | 20.1% |
| Any Secukinumab (AIN457) 150 mg | 33 | 263 | 12.5% |
| Placebo | 5 | 122 | 4.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Any Secukinumab (AIN457) 75 mg | 2 of 179 |
| Any Secukinumab (AIN457) 150 mg | 1 of 263 |
| Placebo | 1 of 122 |
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 |
|---|---|
| Any Secukinumab (AIN457) 75 mg | 126 of 179 |
| Any Secukinumab (AIN457) 150 mg | 157 of 263 |
| Placebo | 45 of 122 |
Most frequent serious adverse event terms
| Event term | Organ system | Any Secukinumab (AIN457) 75 mg | Any Secukinumab (AIN457) 150 mg | Placebo |
|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | 3 of 179 | 3 of 263 | 0 of 122 |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | 2 of 179 | 3 of 263 | 0 of 122 |
| Cardiac failure | Cardiac disorders | 1 of 179 | 2 of 263 | 0 of 122 |
| Cholelithiasis | Hepatobiliary disorders | 3 of 179 | 0 of 263 | 0 of 122 |
| Cerebrovascular accident | Nervous system disorders | 1 of 179 | 2 of 263 | 0 of 122 |
| Cataract | Eye disorders | 1 of 179 | 1 of 263 | 0 of 122 |
| Iridocyclitis | Eye disorders | 0 of 179 | 2 of 263 | 0 of 122 |
| Uveitis | Eye disorders | 0 of 179 | 2 of 263 | 0 of 122 |
| Diarrhoea | Gastrointestinal disorders | 1 of 179 | 1 of 263 | 0 of 122 |
| Hiatus hernia | Gastrointestinal disorders | 2 of 179 | 0 of 263 | 0 of 122 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Any Secukinumab (AIN457) 75 mg | Any Secukinumab (AIN457) 150 mg | Placebo |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 45 of 179 | 63 of 263 | 9 of 122 |
| Diarrhoea | Gastrointestinal disorders | 26 of 179 | 29 of 263 | 7 of 122 |
| Headache | Nervous system disorders | 26 of 179 | 28 of 263 | 7 of 122 |
| Upper respiratory tract infection | Infections and infestations | 29 of 179 | 21 of 263 | 2 of 122 |
| Influenza | Infections and infestations | 19 of 179 | 26 of 263 | 2 of 122 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 17 of 179 | 24 of 263 | 4 of 122 |
| Pharyngitis | Infections and infestations | 13 of 179 | 24 of 263 | 1 of 122 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 14 of 179 | 18 of 263 | 6 of 122 |
| Dyslipidaemia | Metabolism and nutrition disorders | 18 of 179 | 14 of 263 | 5 of 122 |
| Back pain | Musculoskeletal and connective tissue disorders | 13 of 179 | 20 of 263 | 0 of 122 |
Serious events with the highest arm-level rate: myocardial infarction (1.7%), cholelithiasis (1.7%), ankylosing spondylitis (1.1%), hiatus hernia (1.1%), appendicitis (1.1%).
The registry reports serious and other adverse-event figures for three listed groups. For Any Secukinumab (AIN457) 75 mg, 179 participants were at risk for each category; 36 were affected by serious adverse events and 126 by other adverse events. For Any Secukinumab (AIN457) 150 mg, 263 were at risk for each category; 33 were affected by serious adverse events and 157 by other adverse events. For Placebo, 122 were at risk for each category; 5 were affected by serious adverse events and 45 by other adverse events. The death counts were 2, 1, and 1, respectively.
These are descriptive counts from the registry record. The group labels and affected counts should be read as recorded, not as evidence that a treatment caused or prevented an event. The record does not report exposure-adjusted rates, a statistical comparison, or details sufficient to assess differences in follow-up between groups. Participants may also be represented in more than one treatment-history description; the record does not explain overlap in a way that permits the groups to be combined or directly compared.
The listed serious adverse-event terms include Myocardial infarction and Cholelithiasis at 1.7% each, and Ankylosing spondylitis, Hiatus hernia, Appendicitis, and Laceration at 1.1% each. These terms describe reported events; the record does not provide a causal assessment for them. The counts and terms alone do not establish comparative safety or the likelihood of an event over a defined exposure duration.
12. What the Result Does, and Does Not, Mean
The study record describes a randomized, quadruple-masked, parallel extension in participants with active ankylosing spondylitis who had participated in a phase III core study. Its primary endpoint was intended to quantify the sustainability of clinical benefit using ASAS 20 response from Week 104 to Week 260. The endpoint definition and intended population are reported, as are selected adverse-event counts.
The record does not report the primary endpoint result. It explicitly states that no statistical analysis was performed, and no response count, percentage, uncertainty interval, or group comparison is posted. This means that the registry information cannot establish the observed level of ASAS 20 response, how that response changed over time, or whether it differed across the listed dose and treatment-history groups.
The study aim is not itself a result. A stated aim to evaluate sustainability does not demonstrate that a response was sustained. Likewise, a completed study status and an endpoint spanning an extended follow-up period do not substitute for response data. The outcome values and their precision are not reported in the registry record.
The safety counts document reported affected-participant numbers in the listed groups, including deaths and selected serious adverse-event terms. They do not, on their own, indicate whether one group had greater risk than another. The record does not give an inferential safety comparison or enough information to assess event rates across different exposure durations. Nor do event listings alone show that an event was caused by a study treatment.
General statistical interpretation: conclusions from an extension study are most informative when outcome data, analysis denominators, follow-up completeness, and the methods used to handle missing observations are available. Those details are not reported for the primary endpoint in this record. The appropriate reading is therefore limited: the design and measurement approach are described, but the posted registry record does not provide a quantitative efficacy conclusion or a comparative safety conclusion.
13. Why This Trial Matters Statistically
This study raises a common statistical challenge: an extension may be designed to examine whether clinical response persists over a longer treatment period, while the registry outcome entry may not include an analyzed response result. Here, the primary endpoint is clearly defined as ASAS 20 response from Week 104 to Week 260, and the record explains the clinical domains included in that response criterion. But because no statistical analysis was performed, the intended long-term question cannot be answered quantitatively from the posted primary outcome information.
The extension also involves treatment histories and dosing changes. The listed descriptions distinguish prior placebo from prior secukinumab and include different doses, with one group up-titrated after unblinding. The primary outcome description says that up-titrated participants remain counted in their originally randomized treatment group. This highlights the importance of defining how treatment assignment and later treatment changes relate to the analysis, particularly when interpreting an extension over a long interval.
More generally, sustained-response questions depend not only on the response definition but also on who remains under observation, how missing assessments are handled, and how results are summarized over time. The registry does not report the primary endpoint denominators by time point, missing-data methods, or a statistical model. These are not minor details for interpreting a long-term response summary; they determine what population the estimate describes and how much uncertainty surrounds it.
The record also illustrates why descriptive safety counts should be distinguished from comparative analyses. It reports counts for serious and other adverse events and deaths, but does not report an inferential comparison or exposure-adjusted rates. Those counts contribute to the record of observed events, yet they do not by themselves quantify comparative risk.
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 statistical interpretation is that the registry record states that no statistical analysis was performed for the primary endpoint. It does not report ASAS 20 response counts, percentages, confidence intervals, or comparisons. As a result, the central outcome cannot be assessed quantitatively from the posted primary outcome entry.
The endpoint covers Week 104 to Week 260 and is described across multiple categories or time points, but the registry does not reduce it to one comparison. Results at individual time points and the number of participants contributing data at each time point are not reported in the registry record. The approach to multiplicity is also not reported.
The extension population consists of participants from a core study who enrolled in the extension. The record defines the extension Full Analysis Set as all extension enrollees, but it does not report information about eligible participants who did not enroll or the representativeness of enrollees. The number with missing endpoint assessments, reasons for missingness, and methods for handling missing data are not reported in the registry record.
The intervention descriptions include different doses, prior treatment histories, and an up-titration after unblinding. Although the primary endpoint description says up-titrated participants are counted in their originally randomized group, the record does not provide group-specific response results or explain any other treatment changes in the analysis. Details of the randomization procedure and which roles were masked are also not reported in the registry record.
For safety, counts are available, but exposure-adjusted rates, comparative tests, and a causal assessment of listed events are not. The record does not give enough detail to determine whether follow-up or exposure differed across the listed groups. These limitations restrict comparative interpretation of both efficacy and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Extension in AS: Sustainability of Benefits, Safety and Tolerability — NCT01863732.
- Registry record last updated 2019-07-30; status last verified 2019-06.
- Results first posted 2019-07-30.
- 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
NCT01863732 is a completed phase III randomized, quadruple-masked, parallel extension study with enrollment of 274. It evaluated secukinumab in participants with active ankylosing spondylitis who had participated in the phase III core study CAIN457F2305. The primary outcome was ASAS 20 response from Week 104 to Week 260, defined using improvement in at least 3 of 4 clinical domains without worsening in the fourth.
The registry record states that no statistical analysis was performed for the primary outcome. It does not report an ASAS 20 response percentage, confidence interval, or comparison. ASAS 40 response is listed as a secondary outcome. Descriptive safety counts are reported for Any Secukinumab (AIN457) 75 mg, Any Secukinumab (AIN457) 150 mg, and Placebo, including serious and other adverse events and deaths.
The record describes the study design and endpoint but does not provide enough analyzed outcome information to assess the magnitude or precision of primary response results or to make statistical comparisons between groups.