Measurement of Relaxin Peptide in Multiple Sclerosis (MS): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Measurement of Relaxin Peptide in Multiple Sclerosis (MS) (NCT01909492), a registered phase not stated study. The primary outcome is Relaxin (RLX) Levels.

2. Clinical Question

The study asks whether relaxin (RLX) levels in serum and cerebrospinal fluid differ across groups defined by multiple sclerosis status and clinical activity. Its stated motivation is that the registry record describes a lack of information about observed RLX levels in active versus stable relapsing MS, comparison with people without MS or other inflammatory diseases, and whether RLX functions normally in these groups. The primary measure is RLX2 concentration, expressed in pmol/mL.

3. Trial Design

This is a completed, non-randomized study record titled “Measurement of Relaxin Peptide in Multiple Sclerosis (MS).” Providence Health & Services is listed as the sponsor. The registry lists enrollment of 30 and describes three groups, each planned to consist of 10 subjects. The listed study dates are a start date of 2013-09-20 and primary completion on 2023-10-05.

The groups distinguish subjects with suspected MS and recent clinical and MRI evidence, subjects with clinically stable definite MS, and subjects without evidence of inflammatory disease who require CSF removal for another cause. The exact allocation process is not reported in the registry record. The registry explicitly cautions that the arms are not a like-for-like control comparison, so the groups should not be treated as though they were randomized treatment arms.

The procedures listed are blood draw and lumbar puncture. The primary outcome is RLX levels, with RLX2 concentrations expressed in pmol/mL of serum or CSF and assessed during diagnostic LP. The record lists one outcome measure but no analyses. It does not report the assay procedures, the timing of specimen processing, or details of how the group comparisons were to be conducted.

The group descriptions give clinical and imaging features used to characterize the groups. Group 1 includes a recent attack and at least one gadolinium-enhancing lesion on a recent brain or spinal cord MRI, and the description states that subjects had not received immunomodulating or immunosuppressant medication. Group 2 is described as meeting the Revised (2010) McDonald’s Criteria for the Diagnosis of M, but the registry text is truncated at that point. The full eligibility criteria are therefore not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Relaxin (RLX) Levels, measured over During diagnostic LP.

The primary endpoint is RLX level, measured as RLX2 concentration in serum or cerebrospinal fluid and expressed in pmol/mL. The stated timeframe is during diagnostic lumbar puncture. This is a laboratory measurement, not a clinical outcome such as relapse, disability, or treatment response. The registry describes the reason for measuring it as a lack of information about levels in active and stable relapsing MS, comparison with people without MS or other inflammatory diseases, and whether RLX functions normally in people with active or stable MS.

In general, measuring a biomarker across clinically characterized groups can describe whether concentrations vary with the characteristics used to define those groups. The relevance of any observed difference depends on how specimens were collected and measured, how the groups were selected, and how uncertainty was quantified. Those details and the actual concentration results are not reported in the registry record. The outcome entry identifies the unit and specimen types but does not give a summary statistic, a distribution, a group contrast, or a confidence interval. Consequently, the endpoint’s recorded definition does not establish what levels were observed or how precisely they were estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies RLX levels as the primary outcome and expresses RLX2 concentration in pmol/mL of serum or CSF. The measurement timeframe is during diagnostic LP. General statistical interpretation of a continuous biomarker commonly begins with summaries of its distribution within each group, followed by a comparison that reflects the study design. The registry does not report the assay method, the form of the planned summaries, the comparison method, or the results. No particular model or test should therefore be attributed to this study.

What does a confidence interval tell the reader?

In general, a confidence interval describes uncertainty around an estimate under the assumptions of the method used to construct it. It can help distinguish a precise estimate from one compatible with a broad range of values. It does not make a biased comparison unbiased, and it does not by itself establish clinical or biological importance. No confidence interval for the primary outcome is reported in the registry record. As a result, neither the estimated group differences nor their statistical precision can be assessed.

Why does the design affect interpretation?

The record describes three groups with different clinical and eligibility features, and states that allocation is not stated and the arms are not a like-for-like control comparison. In general, a comparison between groups selected on different characteristics is observational rather than a randomized treatment comparison. A group difference can be associated with the group definition without showing that the defining condition caused the difference. Interpretation also depends on whether relevant characteristics were measured and handled appropriately in analysis. The registry does not report an adjusted analysis or covariates, so none can be assumed.

The group descriptions specify 10 subjects per group, while the registry lists enrollment of 30. These figures describe the record’s stated group sizes and enrollment; they do not provide the number with analyzable serum or CSF measurements. The number with endpoint data, exclusions from analysis, and reasons for missing specimens are not reported in the registry record.

What do the planning assumptions mean?

The record’s planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrated effect is a stated fraction of the observed effect. These are planning assumptions, not a report of the study’s original design justification. The registry does not report the original sample-size justification or explain whether those assumptions were used when the study was designed.

In general, a sample-size illustration estimates how many participants per arm might be needed to detect a specified effect under stated assumptions. Such an estimate depends on the effect used, variability, allocation, test, and desired power. It is a planning aid, not “observed power” and not evidence that the study had adequate power. The registry record does not report the observed RLX effect or the variability needed to verify a numerical illustration. It also does not report a planned power target. Any planning estimate should therefore be interpreted as conditional on its assumptions, not as a feature of the observed outcome.

Why might biomarker data need methods beyond a simple comparison?

In general, biomarker measurements can have skewed distributions, values near a detection limit, or variability that differs between groups. A method based on a normal approximation may not describe those features well if its assumptions do not fit the data. Over-dispersion, in general, means that observed variability exceeds what a chosen model expects; ignoring it can make uncertainty appear smaller than it is. The registry does not describe the distribution of RLX values, detection limits, transformations, or checks of model assumptions, so these issues cannot be evaluated for this study.

The registry lists one primary outcome measure and no analyses. It does not report the statistical analysis plan, treatment of multiple comparisons, interim analyses, or prespecified subgroup analyses. Those details are not reported in the registry record. Accordingly, the methods that can be described are limited to the endpoint, specimen types, timeframe, group descriptions, and stated planning assumptions; no outcome analysis can be reconstructed from the registry entry.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure: RLX levels, expressed as RLX2 concentration in serum or CSF. Although the endpoint includes two specimen types and the study has three groups, the record does not explain how many comparisons were planned or which comparisons were primary. A policy for multiplicity, such as adjustment across several comparisons or outcomes, is not reported in the registry record. No analyses are listed, so it is not possible to determine whether multiple testing was performed or how it was handled.

Missing-data information is also absent. The record lists enrollment of 30 and describes 10 subjects per group, but it does not report how many subjects contributed usable serum measurements or CSF measurements. The number of missing or unevaluable specimens, reasons for missingness, and any imputation or other missing-data method are not reported in the registry record. In general, missingness can affect how representative an analyzed group is of the enrolled group; its implications depend on why data are missing and how the analysis handles them.

The analysis populations are not described. It is not reported whether all enrolled subjects were included in the primary analysis, whether analyses were restricted to subjects meeting particular diagnostic criteria, or whether separate populations were defined for serum and CSF results. The statistical analysis plan and any interim analyses are not reported in the registry record. Without these details and the posted outcome results, the completeness of the analysis and the sensitivity of conclusions to missing data cannot be assessed.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The registry records no serious adverse events in Group 1, Group 2, or Group 3: each group has 10 subjects at risk and 0 affected. It also records 0 deaths in each group. Under the other adverse-event category, the counts are 5 of 10 in Group 1, 9 of 10 in Group 2, and 10 of 10 in Group 3. These are the safety counts recorded for the study groups; they are not results for the primary RLX endpoint.

In general, a recorded count of zero serious events means that none were recorded in the stated group during the reporting period. It does not establish that an event is impossible or that risk is absent. The registry does not list serious adverse-event terms, and it does not provide further detail about event types, timing, severity among other events, or how events were attributed. The other-event counts should not be interpreted as a comparison of treatment safety: the study is not described as a randomized treatment comparison, and the groups differ by their clinical definitions. The safety figures therefore describe what the registry records, without establishing a causal difference between groups.

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

This study record is relevant as a description of an effort to measure relaxin in serum and CSF among people in different MS-related clinical groups and a group without evidence of inflammatory disease. It identifies an endpoint, specimen types, units, and group characteristics. That information clarifies the scientific question the study was designed to address.

It does not establish whether RLX concentrations were higher, lower, or similar across groups. The registry record does not report the observed values, group summaries, estimates of difference, or statistical uncertainty. As a result, the biomarker question remains unanswered by the results posted in this record. The completed status is not a substitute for the missing outcome data.

The design also limits what a group comparison could mean. The registry states that the arms are not a like-for-like control comparison and does not identify random allocation. The groups differ by clinical and imaging status and by the reason for CSF removal. In general, observed differences in a biomarker across such groups would describe an association in the studied groups, not demonstrate that MS activity caused a change in relaxin. The record does not report methods that would allow adjustment for differences between groups.

Likewise, the stated planning assumptions do not show that a clinically important difference was detected. Sample-size calculations are illustrations under assumptions, not observed evidence. The registry does not report the primary outcome effect or its precision, so neither statistical significance nor practical importance can be assessed. No medical conclusion about relaxin or MS should be drawn from the absence of posted outcome results. The narrow interpretation supported by the record is that the study was completed and registered as a relaxin measurement study, while the outcome findings and analysis needed to answer its stated question are not reported in the registry record.

13. Why This Trial Matters Statistically

Statistically, this record illustrates the distinction between a clearly stated measurement objective and an interpretable result. It specifies that RLX2 concentrations were to be measured in serum or CSF, gives the unit, and defines three groups with contrasting clinical characteristics. Those details help identify the target of the investigation. However, without outcome summaries and uncertainty estimates, the reader cannot tell whether the measurements varied across groups or how reliable any apparent difference might be.

The study also highlights why group definitions and allocation matter. The registry cautions that the arms are not a like-for-like control comparison, and allocation is not stated. General statistical reasoning treats such group comparisons differently from randomized treatment contrasts: group membership may coincide with other features that also relate to the measurement. The design can still be informative for describing biomarker patterns, but causal claims require evidence and assumptions not established by this record.

Another statistical lesson is that planning assumptions and observed findings serve different purposes. The record describes a planning illustration with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These assumptions do not reveal the original design rationale or the study’s achieved precision. Without observed effects, variability, and outcome results, a planning calculation cannot answer whether the study was informative about its primary endpoint.

Finally, recording enrollment and group sizes is not the same as reporting analyzable endpoint data. The numbers with usable serum or CSF measurements, missingness, and analysis populations are not reported in the registry record. These omissions prevent a full assessment of data completeness and analysis choices. The record is therefore useful for understanding the question and design, but not for evaluating the magnitude or precision of the biomarker findings.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this study is that the registry record does not report RLX outcome values or statistical analyses. No group summaries, contrasts, confidence intervals, or p-values are listed. The magnitude, direction, and precision of the primary endpoint therefore cannot be evaluated.

The group descriptions also make clear that these are not like-for-like control groups. Group 1 is defined by suspected MS and recent clinical and MRI features, Group 2 by clinically stable definite MS and MRI findings, and Group 3 by absence of inflammatory disease and a separate reason for CSF removal. Allocation is not stated. These features limit direct interpretation of between-group comparisons and do not support treating the study as a randomized comparison.

Additional methods needed for appraisal are not reported in the registry record. These include the assay method, how results were summarized, the statistical analysis plan, adjustments for group differences, handling of missing specimens, analysis populations, and any multiplicity approach. The full eligibility descriptions are not available in the registry text for Group 1 and Group 3, and the Group 2 description is truncated. The number of subjects with analyzable measurements is also not reported, even though the record lists enrollment of 30 and describes 10 subjects in each group.

The safety entry gives counts but little context about event terms or reporting details. These counts should be read separately from the unreported biomarker findings. Taken together, the available registry information describes the intended question and broad design, but not the evidence needed for a complete statistical assessment of the primary outcome.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Measurement of Relaxin Peptide in Multiple Sclerosis (MS) — NCT01909492.
• Registry record last updated 2025-06-22; status last verified 2025-06.
• Results first posted 2025-06-22.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT01909492 is listed as completed and is sponsored by Providence Health & Services. The registry lists enrollment of 30, a study start date of 2013-09-20, and primary completion on 2023-10-05. It describes three groups of 10 subjects: suspected MS with recent clinical and MRI findings, clinically stable definite MS, and subjects without evidence of inflammatory disease who require CSF removal for another cause.

The listed procedures are blood draw and lumbar puncture. The primary outcome is RLX2 concentration in serum or CSF, expressed in pmol/mL and measured during diagnostic LP. The registry lists one outcome measure and no analyses. Numerical outcome results and details of the statistical analysis are not reported in the registry record. The record also cautions that the arms are not a like-for-like control comparison and does not state allocation.