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 Start Time Optimization of Biologics in Polyarticular JIA (NCT02593006), a registered phase not stated study. The primary outcome is Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02593006 |
| Phase | Phase not stated |
| Condition | Polyarticular Juvenile Rheumatoid Arthritis, Arthritis, Juvenile Idiopathic |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 400 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hackensack Meridian Health |
| Results posted | Yes |
2. Clinical Question
Population
Children and adolescents between the ages of 2 and 18 who were newly diagnosed with a polyarticular form of juvenile idiopathic arthritis. The primary endpoint description refers to participants treated for 12 months with one of the consensus treatment plans.
Intervention
The study compared three consensus treatment plans: Step-Up CTP, Early Combination CTP, and Biologic First CTP. These were standard-of-care strategies selected by the treating physician together with the patient or caregiver; treatment was not randomized.
Comparator
Each treatment strategy was considered in relation to the other strategies. Because assignment was not randomized and the registry record does not state how treatment selection was allocated, the groups should not be read as like-for-like control groups.
Primary question
For each treatment strategy, what proportion of participants achieved clinically inactive disease while off glucocorticoids at 12 months after baseline? The registry record gives the endpoint definition and specifies a 95% confidence interval, but it does not report the arm-specific proportions or interval limits.
STOP-JIA was designed to address a timing question: when biologic medications are begun as part of treatment for newly diagnosed polyarticular JIA, how do clinical and patient-reported outcomes compare across the three consensus-derived strategies? This is a comparison of treatment approaches used in routine care, rather than a randomized test in which investigators assigned participants to a strategy.
The clinical question therefore has two parts. One is whether the strategies differ in the proportion reaching the defined disease state at the stated follow-up. The other, reflected in the registry’s secondary outcome description, concerns PROMIS Pain and Mobility scores across the three groups. The registry record does not give numerical results for either question, so it does not establish the size, direction, or precision of any between-group difference.
3. Trial Design
STOP-JIA is described in the registry record as a prospective observational study of three CARRA consensus-derived treatment plans for new-onset polyarticular JIA. The record lists Hackensack Meridian Health as the sponsor and an enrollment of 400. The study is marked completed; the recorded start is 2015-11 and the primary completion date is 2019-09-30.
The treatment strategies were Step-Up CTP, Early Combination CTP, and Biologic First CTP. According to the study description, standard-of-care treatment was chosen by the treating physician and patient or caregiver, rather than assigned randomly. All patients were to be enrolled in the CARRA Registry for data collection. The registry record does not state the allocation mechanism beyond noting that treatment was not randomized.
The primary outcome was the percentage of participants with clinically inactive disease off glucocorticoids at 12 months after baseline. The outcome description identifies the target population as children and adolescents between the ages of 2 and 18 with newly diagnosed polyarticular JIA who were treated for 12 months with a consensus treatment plan. It also states that 328 participants had complete data for the primary CID endpoint at 12 months. This count describes availability of complete endpoint data, not the number with the endpoint.
The registry lists comparison of PROMIS Pain and Mobility scores between the three consensus treatment plan groups as a secondary outcome. Numerical results for this secondary outcome are not reported in the registry record. The record lists two outcome measures and two analyses, but a fuller statistical analysis plan, including model specifications and adjustment choices, is not reported.
Because care was not randomized, comparisons reflect treatment strategies selected in clinical care. Differences between groups could be associated with characteristics that influenced treatment selection as well as with the strategies themselves. The registry record does not provide enough detail to determine how such factors were handled in analysis.
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 | Step-Up CTP | Early Combination CTP | Biologic Frist CTP |
|---|---|---|---|
| STARTED | 257 | 100 | 43 |
| COMPLETED | 250 | 93 | 38 |
| NOT COMPLETED | 7 | 7 | 5 |
Analysis population for the primary outcome, as defined in the registry: Subjects are children and adolescents between the ages of 2 and 18 who are newly diagnosed with a polyarticular form of JIA and treated for 12 months with one of the consensus treatment plans. 328 participants had complete data for the primary CID endpoint at 12 months
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 | Step-Up CTP | Early Combination CTP | Biologic Frist CTP | Total |
|---|---|---|---|---|---|
| Participants analysed | 257 | 100 | 43 | 400 | |
| Age, Categorical: <=18 years | Participants | 257 | 99 | 43 | 399 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 1 | 0 | 1 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 11.07 (1.10 to 17.85) | 11.38 (1.15 to 18.41) | 12.34 (1.40 to 17.95) | 11.28 (1.10 to 18.41) |
| Sex: Female, Male: Female | Participants | 192 | 75 | 27 | 294 |
| Sex: Female, Male: Male | Participants | 65 | 25 | 16 | 106 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 0 | 0 | 3 |
| Race (NIH/OMB): Asian | Participants | 15 | 4 | 2 | 21 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 15 | 5 | 3 | 23 |
| Race (NIH/OMB): White | Participants | 188 | 68 | 27 | 283 |
| Race (NIH/OMB): More than one race | Participants | 9 | 3 | 5 | 17 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 27 | 19 | 6 | 52 |
| Region of Enrollment: Canada | participants | 32 | 2 | 1 | 35 |
| Region of Enrollment: United States | participants | 225 | 98 | 42 | 365 |
| Clinical Juvenile Arthritis Disease Activity Score | units on a scale | 17.08 (SD 4.55) | 20.18 (SD 4.37) | 19.05 (SD 4.29) | 18.08 (SD 4.67) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids, measured over 12 months after baseline.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants achieving CID |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of participants with clinically inactive disease, or CID, off glucocorticoids at 12 months after baseline. The registry describes CID as a provisional set of criteria for a state of complete disease inactivity in juvenile idiopathic arthritis. The endpoint is assessed separately for each consensus treatment plan.
This endpoint combines a clinical disease-state criterion with a treatment-status condition: participants must meet the CID definition and be off glucocorticoids at the assessment. It is therefore not simply a measure of symptom change, nor does the registry describe it as a continuous score. The stated unit is a percentage of participants achieving CID. The registry specifies a 95% confidence interval for the endpoint, but does not provide the interval limits or arm-specific percentages.
In general, a proportion endpoint gives an interpretable summary of how often a prespecified state is reached in a group. A confidence interval conveys statistical uncertainty around the estimated proportion; it is not a guarantee that the true proportion lies within the interval. The interval’s width depends on the amount and variability of available information, among other factors. No interval widths can be discussed for this study because the endpoint estimates are not reported in the registry record.
The endpoint is relevant to the study’s stated clinical question because it focuses on a disease state after a defined period of treatment. However, the registry record does not provide the detailed operational criteria used to determine CID, how glucocorticoid status was established, or how endpoint assessment was conducted. Those details are not reported in the registry record, so the endpoint label alone does not resolve questions about measurement or assessment procedures.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its follow-up point, but does not report the observed proportion achieving CID off glucocorticoids in any of the three treatment groups. It also does not report the associated 95% confidence interval limits. As a result, the posted registry information does not allow a reader to assess the magnitude or precision of the primary endpoint estimates, or to determine whether the groups differed on that endpoint.
The same limitation applies to the PROMIS Pain and Mobility comparison. The registry describes this as a secondary outcome, but does not report group scores, changes, between-group contrasts, uncertainty intervals, or a test result. It is therefore not possible to characterize the direction or size of the patient-reported outcome findings from the registry record.
Even if group-specific values were available, the study design would matter for interpretation. The study was observational, and the treatment strategies were selected by the treating physician and patient or caregiver rather than assigned randomly. This means the groups may differ in ways that are related to treatment choice and outcomes. The registry record does not describe whether or how analyses adjusted for such differences. An observed group contrast would therefore be an association in this study unless a sufficiently detailed analysis supported a stronger interpretation; the registry information alone does not establish a causal treatment effect.
The stated enrollment is 400, while the primary endpoint description says 328 participants had complete data for the CID endpoint at 12 months. These figures describe enrollment and endpoint completeness, respectively. They do not show how many participants achieved CID, and the record does not report the arm-specific endpoint denominators used in the analysis. The reasons for incomplete endpoint data and the handling of missing observations are also not reported in the registry record.
The adverse-event figures are separate from the primary efficacy endpoint. They describe counts of serious and other affected participants within the listed treatment groups, along with selected serious-event terms and percentages. They do not provide a basis for comparing treatment safety without further information about event definitions, follow-up, exposure, and analysis. The registry record does not report those details.
In short, the registry record establishes the study question, treatment strategies, endpoint definition, and some data-availability and safety counts. It does not provide the numerical primary or secondary outcome results needed to judge observed differences or their statistical precision. No conclusion about which strategy had a higher CID proportion, or whether any contrast was statistically distinguishable, can be drawn from the posted results described in the record.
9. Statistical Methods Explained
What does a percentage endpoint represent?
The primary outcome is a proportion: the number of participants meeting the CID-off-glucocorticoids definition in a treatment group, considered relative to the participants assessed for that endpoint in that group. The registry describes the outcome as a percentage and specifies a 95% confidence interval. It does not report the group-level numerators, denominators, percentages, or interval bounds. Those values cannot be reconstructed from the total enrollment and the statement about complete primary endpoint data.
In general, a confidence interval summarizes uncertainty associated with an estimate under the assumptions of the statistical method used. It does not describe the range of outcomes for individual participants, and it is not a probability statement about a particular treatment being best. A narrower interval generally indicates greater precision under the method’s assumptions; a wider interval indicates less precision. Since interval limits are not reported in the registry record, precision cannot be compared across groups.
What can an observational comparison establish?
The treatment plans were selected by the treating physician and patient or caregiver, and the study was not randomized. In general, random allocation helps balance measured and unmeasured characteristics between treatment groups on average. In an observational comparison, groups can differ at baseline or in clinical circumstances that influence treatment choice. If those characteristics also relate to outcome, a crude group difference may reflect both treatment selection and outcome variation, rather than the strategy alone.
Statistical adjustment can sometimes address measured differences, but it does not automatically remove confounding, especially from factors that were not measured or were measured poorly. The registry record does not report the analysis model, adjustment variables, or whether estimates were adjusted. It is therefore not possible to tell from the registry whether the primary comparison was unadjusted, adjusted, or analyzed using another approach. The record also does not report a prespecified statistical analysis plan.
What does the endpoint’s confidence interval add?
For a group-specific proportion, an interval provides information about the uncertainty around that estimate. For a comparison between groups, uncertainty around the contrast is also important: group intervals considered separately do not necessarily provide the same information as an interval calculated directly for a difference or other contrast. The registry record does not report a contrast estimate or its confidence interval. No specific between-group uncertainty assessment can therefore be described.
In general, the construction of an interval for a proportion depends on the method and on the available data. The registry record specifies the 95% confidence level but does not identify the interval method. It also does not state whether the reported estimate, if available, would account for any features such as missing data or differences between treatment groups. Those methodological details are not reported in the registry record.
Why do analysis populations and missing observations matter?
The primary outcome description states that 328 participants had complete data for the CID endpoint at 12 months. Complete-case results, if used, would be based on participants with the necessary endpoint information. In general, such an analysis can be difficult to interpret if the availability of complete data is related to participant characteristics or outcomes. Other approaches can use assumptions or additional information to address missing observations, but each approach has assumptions that should be stated.
The registry record does not say whether the primary analysis included only participants with complete endpoint data, used an imputation method, or followed another rule. It does not describe reasons for missing endpoint information, whether missingness differed across the treatment groups, or any sensitivity analyses. Without those details, the effect of incomplete data on the reported estimates cannot be assessed.
What does the safety summary count?
The safety information lists, for each treatment group, numbers at risk and numbers affected for serious and other adverse events, as well as deaths. It also lists selected serious-event terms with percentages. These are descriptive counts in the registry record; they should not be interpreted as comparative effect estimates without knowing the event definitions, observation periods, exposure, and method used to calculate the percentages.
In general, adverse-event comparisons can be affected by how long participants are observed and by how events are collected and classified. A count of affected participants is not necessarily the same as a count of all event occurrences if participants can have more than one event. The registry record does not specify whether its affected counts represent unique participants under a particular event rule, nor does it describe event ascertainment or follow-up for safety. No rate or adjusted comparison should be inferred from these counts.
What statistical plan is documented?
The registry identifies the primary endpoint, its time point, and a 95% confidence interval, and it identifies PROMIS Pain and Mobility as a secondary outcome. It does not report the test procedures, model forms, covariate selection, multiplicity strategy, interim analyses, or sample-size justification. The study enrollment is recorded as 400, but the record does not state the reasoning behind that enrollment figure. Those omissions mean that the intended analysis and the role of any statistical testing cannot be fully reconstructed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary endpoint and a secondary outcome comparing PROMIS Pain and Mobility scores across the three treatment-plan groups. It also lists two outcome measures and two analyses. The registry record does not describe how many formal hypotheses were tested, which comparisons were prespecified, whether particular pairwise contrasts were prioritized, or how the analysis addressed multiplicity.
In general, testing multiple outcomes or multiple group contrasts increases the chance of obtaining at least one apparently notable result by chance if each is assessed independently at a conventional threshold. A multiplicity strategy can define how interpretation or statistical testing accounts for that family of comparisons. No such strategy is reported in the registry record, so it is not possible to determine whether multiplicity was addressed or how it should affect interpretation of the study’s analyses.
The primary outcome description states that 328 participants had complete data for the CID endpoint at 12 months. The registry does not report whether the analysis included only those participants, used another analysis population, or applied a method to handle missing outcomes. Reasons for incomplete data, group-specific completeness, and sensitivity analyses are not reported in the registry record. Consequently, the possible impact of missing endpoint information on the estimates cannot be assessed.
The registry also does not state whether an intention-to-treat concept was used. Since treatment was not randomized, that label would require a defined analysis rule and cannot be assumed from the design description. The record does not provide a protocol or statistical analysis plan describing analysis populations, missing-data assumptions, or sensitivity checks. These are important uncertainties when interpreting any outcome estimates, even though arm-specific primary and secondary results are not reported in the registry record.
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 |
|---|---|---|---|
| Step-Up CTP | 12 | 257 | 4.7% |
| Early Combination CTP | 3 | 100 | 3.0% |
| Biologic First CTP | 5 | 43 | 11.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Step-Up CTP | 0 of 257 |
| Early Combination CTP | 0 of 100 |
| Biologic First CTP | 0 of 43 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Step-Up CTP | 19 of 257 |
| Early Combination CTP | 5 of 100 |
| Biologic First CTP | 1 of 43 |
Most frequent serious adverse event terms
| Event term | Organ system | Step-Up CTP | Early Combination CTP | Biologic First CTP |
|---|---|---|---|---|
| Infections treated with IV antibiotics | Infections and infestations | 2 of 257 | 1 of 100 | 2 of 43 |
| Hip Pain | Musculoskeletal and connective tissue disorders | 2 of 257 | 0 of 100 | 0 of 43 |
| Influenza | General disorders | 2 of 257 | 0 of 100 | 0 of 43 |
| Cellulitis | Skin and subcutaneous tissue disorders | 1 of 257 | 0 of 100 | 0 of 43 |
| Cervical Spine Fracture | Injury, poisoning and procedural complications | 1 of 257 | 0 of 100 | 0 of 43 |
| Compund Fracture Ulna & Radius | Injury, poisoning and procedural complications | 0 of 257 | 1 of 100 | 0 of 43 |
| Depression with Suicidal Ideation | Psychiatric disorders | 0 of 257 | 0 of 100 | 1 of 43 |
| Inflammatory Bowel Disease | Gastrointestinal disorders | 1 of 257 | 0 of 100 | 0 of 43 |
| Drug induced Lupus | Immune system disorders | 1 of 257 | 0 of 100 | 0 of 43 |
| hip effusion | Musculoskeletal and connective tissue disorders | 1 of 257 | 0 of 100 | 0 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Step-Up CTP | Early Combination CTP | Biologic First CTP |
|---|---|---|---|---|
| Uveitis (New Onset) | Eye disorders | 9 of 257 | 2 of 100 | 1 of 43 |
| Hepatitis | Hepatobiliary disorders | 3 of 257 | 2 of 100 | 0 of 43 |
| Psoriasis | Skin and subcutaneous tissue disorders | 3 of 257 | 0 of 100 | 0 of 43 |
| Inflammatory Bowel Disease | Gastrointestinal disorders | 1 of 257 | 1 of 100 | 0 of 43 |
| Leukopenia | Blood and lymphatic system disorders | 2 of 257 | 0 of 100 | 0 of 43 |
| Hypersensitivity Reaction | Immune system disorders | 1 of 257 | 0 of 100 | 0 of 43 |
Serious events with the highest arm-level rate: infections treated with iv antibiotics (4.7%), depression with suicidal ideation (2.3%), shingles (2.3%), vertigo (2.3%), compund fracture ulna & radius (1.0%).
The safety record lists serious-event counts, other adverse-event counts, and deaths for Step-Up CTP, Early Combination CTP, and Biologic First CTP. For each group it gives numbers at risk and affected. The serious-event entries are 12 affected among 257 at risk for Step-Up CTP, 3 among 100 for Early Combination CTP, and 5 among 43 for Biologic First CTP. The other-event entries are 19 among 257, 5 among 100, and 1 among 43, respectively. Deaths are listed as 0 in each group.
These are descriptive counts, not an adjusted comparison of safety. The registry record does not report the event observation period, exposure time, detailed definitions, collection method, or statistical comparison. It also does not clarify whether affected counts represent people with at least one event under a specified rule or how repeat events were handled. The counts should therefore not be converted into rates or treated as evidence of a difference between strategies.
The record lists infections treated with IV antibiotics at 4.7%, depression with suicidal ideation at 2.3%, shingles at 2.3%, vertigo at 2.3%, compound fracture ulna and radius at 1.0%, and macrophage activation syndrome at 1.0% among the selected serious-event terms. The denominator and calculation details for these percentages are not reported in the registry record. These terms describe entries in the safety summary, not comparative risks or causal effects of a treatment plan.
12. What the Result Does, and Does Not, Mean
The study addresses an important comparative question about when biologic medications are begun in treatment strategies for newly diagnosed polyarticular JIA. Its prospective observational design captures treatment plans selected in clinical care and follows a defined primary endpoint: CID off glucocorticoids at 12 months after baseline. The record also identifies patient-reported pain and mobility scores as a secondary area of comparison.
However, the registry record does not report the primary endpoint proportions, their 95% confidence intervals, or numerical results for PROMIS Pain and Mobility. It therefore does not establish which strategy had a larger observed proportion achieving CID, how precise any estimate was, or whether any group contrast was statistically distinguishable. It also does not provide enough information to infer the direction or size of the secondary outcome findings.
Even with outcome estimates, an observational study does not by itself establish that the treatment strategy caused a difference. Treatment choice was made by the treating physician and patient or caregiver, not by random allocation. Groups could differ in clinical or participant characteristics associated with the treatment selected and with subsequent outcomes. The registry does not report enough about adjustment to assess how those factors were handled.
The recorded enrollment of 400 should not be mistaken for the number contributing complete data to the primary endpoint; the endpoint description separately states that 328 participants had complete CID data at 12 months. Neither figure indicates how many participants achieved the endpoint. The registry does not report the endpoint denominators by group or explain the missing data.
The serious and other adverse-event counts are also descriptive. Without details on observation, event classification, and exposure, they do not support a comparative safety conclusion. Overall, the record provides the study framework and selected descriptive safety information, but not the outcome estimates needed to characterize clinical or patient-reported differences. It cannot, on its own, establish that one treatment strategy is more effective or safer than another.
13. Why This Trial Matters Statistically
Comparative treatment research in a clinical setting involves both a statistical question and a design question. STOP-JIA’s statistical question concerns differences across three consensus-derived treatment strategies in a disease-state endpoint at a defined follow-up, together with patient-reported pain and mobility. Its observational design is central to how any estimates should be interpreted: treatment was selected in care rather than assigned randomly.
The study also illustrates why outcome definitions and data completeness matter. The primary endpoint is not merely a score; it is the proportion meeting a stated disease-inactivity condition while off glucocorticoids. The registry reports that 328 participants had complete primary endpoint data, making clear that enrollment and outcome completeness are distinct summaries. To evaluate the endpoint estimates, readers would also need the group-specific denominators, outcome counts, confidence intervals, and information about how missing data were handled. Those details are not reported in the registry record.
Patient-reported measures add another dimension to comparison. Pain and mobility may capture experiences that are not identical to a clinical disease-state measure. The record identifies PROMIS Pain and Mobility as a secondary outcome, but does not report its numerical findings. This distinction shows why a study’s outcome framework can be informative even when the posted results do not allow a conclusion about observed group differences.
Finally, a registry entry can document the design, endpoint definitions, enrollment, and selected safety counts without documenting the full analysis plan or all results. Here, the statistical methods, adjustment strategy, multiplicity handling, and sample-size justification are not reported. That gap limits independent assessment of precision and potential bias. The study’s statistical importance lies in the comparative question it poses and the need to interpret observational evidence with attention to treatment selection, endpoint completeness, and reporting transparency—not in a result that the registry record does not provide.
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 posted outcome information is that the registry record does not report arm-specific estimates for the primary CID endpoint or the stated 95% confidence intervals. Numerical results for PROMIS Pain and Mobility are also not reported. The primary endpoint’s direction, magnitude, and precision therefore cannot be evaluated from this record.
The study was not randomized, and treatment was selected by the treating physician and patient or caregiver. The allocation mechanism is not stated in the registry record. This design permits treatment-selection differences between groups, and the record does not describe whether analyses adjusted for measured characteristics or how potential confounding was assessed. The extent to which the groups were comparable is not reported.
The endpoint description says that 328 participants had complete primary CID data at 12 months, but does not provide group-specific completeness, reasons for missing data, or the analysis rule for incomplete outcomes. The operational details for CID assessment and glucocorticoid status are also not reported in the registry record. These omissions limit evaluation of measurement and missing-data effects.
The registry record does not report a detailed statistical analysis plan, including model specifications, covariate adjustment, prespecified contrasts, multiplicity handling, or sensitivity analyses. It does not state the rationale for the recorded enrollment of 400 or whether interim analyses were planned or conducted. Those details are not reported in the registry record.
Safety information is limited to counts and selected serious-event terms with percentages. The record does not describe the observation period, exposure, event definitions, ascertainment, or calculation denominators for the listed percentages. Accordingly, the safety summary does not support a detailed comparative assessment. These limitations concern what can be concluded from the registry record; they do not establish that corresponding information is absent from all study materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Start Time Optimization of Biologics in Polyarticular JIA — NCT02593006.
- Registry record last updated 2021-02-05; status last verified 2021-02.
- Results first posted 2021-02-05.
- 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
STOP-JIA (NCT02593006), sponsored by Hackensack Meridian Health, is a completed prospective observational study of three CARRA consensus-derived treatment strategies for newly diagnosed polyarticular JIA. The registry records enrollment of 400, a start date of 2015-11, and a primary completion date of 2019-09-30. Treatment was chosen by the treating physician and patient or caregiver, not randomly assigned.
The primary endpoint was the percentage of participants with clinically inactive disease off glucocorticoids at 12 months after baseline. The endpoint description states that 328 participants had complete primary CID data at that time point. PROMIS Pain and Mobility comparisons were listed as a secondary outcome. The registry record does not report numerical primary or secondary outcome results, arm-specific confidence intervals, or a detailed statistical analysis plan.
Serious and other adverse-event counts and selected serious-event terms are recorded, but the details needed for comparative safety interpretation are not reported. The posted information defines the study question and selected outcomes, while leaving the magnitude and precision of treatment-group outcome differences undetermined.