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 MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) (NCT02949908), a registered phase not stated study. The primary outcome is Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02949908 |
| Phase | Phase not stated |
| Condition | Multiple Sclerosis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck KGaA, Darmstadt, Germany |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsing-remitting multiple sclerosis who had discontinued initial first-line treatment. The primary outcome population is described as participants who received study medication and had data collected at Month 6. The registry enrollment is 2; the number meeting that outcome-population definition is not reported in the registry record.
Intervention
Rebif, the study medication, was assessed in a prospective, open-label, single-arm study. The record describes the study as non-interventional and focused on participants after discontinuing initial first-line treatment.
Comparator
There was no comparison group. The study is described as uncontrolled and single arm, so it does not directly compare Rebif with another treatment, continued initial treatment, or no treatment.
Primary question
The primary outcome was the treatment satisfaction score determined with the Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Month 6. The registry record describes the measure, but does not report the observed score or its uncertainty.
Statistically, the study addresses a descriptive question: what treatment-satisfaction assessment was recorded among the defined participants at the stated follow-up? It does not provide a randomized contrast or an estimate of how satisfaction would differ under another treatment strategy. The posted record also lists outcomes concerning relapse rate, adherence, quality of life, reasons for discontinuation, and correlations among measures. Their names describe intended outcome topics, not observed findings. No outcome estimates or analysis results are reported in the registry record, so the extent and precision of any measured satisfaction cannot be evaluated from the posted results.
3. Trial Design
The registry describes a Phase IV, prospective, multicenter, open-label, uncontrolled, non-interventional, single-arm study. It concerns participants with relapsing-remitting multiple sclerosis who were taking Rebif after discontinuing initial first-line treatment. Because there is no comparator arm, the design is descriptive rather than a like-for-like treatment comparison. The registry does not state an allocation method; in any event, no randomized comparison is described.
The recorded enrollment is 2. The study status is TERMINATED. The registry lists the start date as 2017-02-09 and the primary completion date as 2017-08-25. It does not report why the study was terminated, whether the recorded enrollment represents the number completing follow-up, or how many participants contributed data to the primary outcome. Those details are not reported in the registry record.
The primary outcome is treatment satisfaction measured with TSQM v II at Month 6. The outcome population is described as participants who received study medication and had data collected at Month 6. The record also names secondary outcomes involving Annualized Relapse Rate, adherence, MusiQoL, discontinuation reasons, and correlations among measures. It labels 17 outcome measures overall, but the posted results contain 0 analyses. The registry does not report a statistical analysis plan or explain how the planned outcomes were to be analyzed.
Open-label means that the study was not described as blinded. General methodological context: when participants and study personnel know which treatment is being used, subjective reports may be influenced by expectations or by knowledge of treatment. That possibility is relevant to a satisfaction measure, but the registry does not establish whether or how such influence occurred.
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 | Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) |
|---|---|
| STARTED | 2 |
| COMPLETED | 0 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) |
|---|---|
| Study termination | 2 |
Analysis population for the primary outcome, as defined in the registry: Analysis population included participant who received study medication and had data collected at Month 6.
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 | Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) |
|---|---|---|
| Participants analysed | 2 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II), measured over Month 6.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the treatment satisfaction score determined with the Treatment Satisfaction Questionnaire for Medication Version II at Month 6. The registry describes TSQM v II as a general medication-satisfaction measure intended for use across medication types and illness conditions. Its description says it consists of 11 question items. Participants were asked to assess their overall satisfaction, with responses ranging from 1 to 7, from Extremely Dissatisfied to Extremely Satisfied.
A satisfaction measure captures participants’ reported experience of treatment rather than an objective clinical event. This can be useful because treatment acceptability and perceived burden are different kinds of information from relapse or quality-of-life outcomes. The registry separately lists outcomes related to relapse rate, adherence, and quality of life, indicating that these were distinct outcome topics in the study record.
The outcome is expressed in units on a scale, with parameter type NUMBER. However, no Month 6 score, measure of variability, confidence interval, or other uncertainty estimate is reported in the registry record. The record also does not explain how responses to the 11 items were combined, or provide a score interpretation beyond the response scale description. The stated outcome population requires receipt of study medication and data collection at Month 6; the number satisfying that definition is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive limitation is that the registry record describes the primary outcome but does not report its observed value. It is therefore not possible to state what treatment-satisfaction score was recorded at Month 6, how that score was distributed, or how precisely it was estimated. The posted results report 0 analyses. Outcome titles alone do not establish that a result was observed or analyzed.
The study’s single-arm, uncontrolled design also limits the questions the data could answer, even if an outcome estimate were available. A score in participants taking Rebif would describe their reported satisfaction in the study context. Without a comparator, it would not estimate how satisfaction differed from another treatment or from a different treatment strategy. It would also not isolate the contribution of Rebif from other influences on reported satisfaction, such as participants’ prior treatment experiences or expectations. These are general interpretive considerations, not findings about these participants.
The registry enrollment is 2, while the primary outcome population is defined by medication receipt and Month 6 data collection. The record does not state how many participants met that definition or whether every enrolled participant contributed outcome data. With the outcome result and analysis population count unreported, neither the magnitude of the observed score nor its precision can be assessed. A small or incomplete set of observations can make estimates unstable, but the record does not provide enough information to characterize the actual uncertainty.
The record lists secondary outcomes, including Annualized Relapse Rate, adherence, MusiQoL scores at Month 6 and 12, discontinuation reasons, and correlations between measures. These entries indicate topics of interest, not evidence of a particular result. No values, statistical tests, or correlation estimates are reported in the registry record. The record does not report whether all listed outcomes were assessed or how missing observations affected them.
Safety counts are also limited descriptive information. The adverse-event record lists 0 participants with serious adverse events, 0 with other adverse events, and 0 deaths among 2 at risk. Such counts do not, by themselves, quantify the precision of safety assessment or establish that no events occurred outside the recorded period or definitions. The registry does not report additional detail about event collection or follow-up in the registry record recorded.
Overall, the posted record permits description of the study’s purpose, design, outcome definitions, enrollment, status, and recorded safety counts. It does not permit an estimate of the primary satisfaction outcome or a comparative conclusion. No treatment benefit or lack of benefit can be inferred from the absence of reported outcome estimates.
9. Statistical Methods Explained
The registry identifies a numeric treatment-satisfaction outcome at Month 6, but it does not report an analysis method or an estimate. The following statistical context is general and does not describe methods confirmed for this study. The statistical analysis plan is not reported in the registry record.
What does a score estimate describe?
A descriptive estimate summarizes observations in the population that contributed data. For a satisfaction outcome, a summary could describe the recorded scores, but its meaning depends on how the questionnaire responses were scored and summarized. The registry says TSQM v II has 11 question items and gives a response scale from 1 to 7. It does not report how item responses were combined into the named treatment-satisfaction score, nor whether the primary analysis was intended to use a mean, a median, or another summary. It is therefore not appropriate to assume a particular scoring or summary method.
The named primary population includes participants who received study medication and had Month 6 data collected. This definition matters because an estimate based only on available observations describes those with data, not automatically everyone enrolled. The number in that analysis population and the handling of participants without Month 6 data are not reported in the registry record.
Why does uncertainty matter?
An estimate is subject to sampling variability: observations from a different set of comparable participants could produce a different estimate. A confidence interval is a general statistical tool for displaying uncertainty around an estimate under specified assumptions. It gives a range of values compatible with the data and method at a stated confidence level; it is not a guarantee that the true value lies within that range. No confidence interval or other uncertainty measure for the primary outcome is reported in the registry record.
With limited observations, estimates and uncertainty measures can be sensitive to individual responses. The registry enrollment is 2, but the count contributing to the Month 6 outcome is not reported. No claim about the precision of the actual satisfaction estimate is possible because the estimate itself and its analysis population are absent. The design also has no comparator, so a confidence interval for a within-group summary, if one had been reported, would not answer a comparative treatment question.
What would a comparison require?
General statistical context: a comparative treatment estimate contrasts outcomes across groups or strategies. In a randomized trial, random allocation is intended to make groups comparable on average, subject to chance and implementation. This record instead describes an uncontrolled, single-arm study. It therefore has no like-for-like control comparison from which to estimate a treatment contrast. Adjusting statistically for measured characteristics cannot create the information from a missing comparator, and no adjustment method is reported in the registry record.
The open-label design is relevant to interpretation of a reported satisfaction measure. General context: participant-reported outcomes may reflect both the experience being measured and expectations or perceptions. Blinding can sometimes reduce certain influences, but this study is described as open label. The record does not report any method intended to address reporting or expectation effects.
What is over-dispersion?
General context: over-dispersion occurs when count data vary more than a chosen statistical model expects. It can make standard errors too small if a model assumes less variability than the data contain. This concept may matter in some analyses of event counts or relapse rates, but it is not evidence that over-dispersion occurred in this study. The registry does not report a count model, a dispersion estimate, or any fitted analysis for Annualized Relapse Rate.
Likewise, a correlation measures the direction and strength of association between two variables under a specified method. The registry lists planned correlations involving TSQM v II, Annualized Relapse Rate, adherence, reasons for discontinuation, and MusiQoL. It reports no correlation coefficients or analysis methods. An association, even if observed, would not establish that one measure caused a change in another.
How should the planning illustrations be read?
The record’s planning assumptions describe illustrations using 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 description of this study’s single-arm design or its observed analysis. The registry does not report the study’s own sample-size justification. Any sample-size illustration is a planning exercise and must not be read as observed power or as evidence that a result was detected. The outcomes and analysis estimates needed to assess such an illustration are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures overall and names secondary outcome topics that include relapse rate, adherence, quality of life, discontinuation reasons, and correlations. It reports 0 analyses. A list of outcomes does not show which were analyzed, which were designated as confirmatory, or what conclusions were drawn. The statistical analysis plan is not reported in the registry record.
When a study examines multiple outcomes or multiple relationships, the chance of obtaining an apparently unusual result can increase if each is tested separately. General statistical approaches can control or describe this issue, for example by adjusting significance thresholds or distinguishing primary from exploratory analyses. The registry does not report whether any multiplicity strategy was planned or used. No conclusion about multiplicity control can be made from the outcome list alone.
Missing-data handling is also not reported in the registry record. The primary population is described as participants who received study medication and had data collected at Month 6, but the record does not state how many met this definition, why any data may have been absent, or whether missing outcomes were imputed, excluded, or otherwise handled. The definition identifies the observations eligible for the primary outcome population; it does not explain the missing-data method.
The registry enrollment is 2, but that figure does not establish the number included in each outcome analysis. The record does not report an intention-to-treat population, a per-protocol population, or another analysis population beyond the primary outcome description. It also does not report interim analyses, prespecified subgroup analyses, or sensitivity analyses. These details should be treated as not reported in the registry record rather than inferred from the design label or outcome names.
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 |
|---|---|---|---|
| Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) | 0 | 2 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) | 0 of 2 |
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 |
|---|---|
| Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS) | 0 of 2 |
The adverse-event record lists the Rebif group with 2 at risk. It reports 0 participants with serious adverse events, 0 participants with other adverse events, and 0 deaths. The record lists no top serious-event terms.
These are counts, not estimates of comparative risk. Because the study is single arm and uncontrolled, the safety record does not compare Rebif with another treatment or a control group. The registry does not report event-specific descriptions, the observation period for these counts, or further details about event ascertainment in the registry record recorded. The absence of listed serious-event terms means none are listed in the record; it does not supply additional information about how events were collected or classified.
General statistical context: a count of 0 observed events does not establish that the underlying event risk is zero. The amount of information in a safety count depends on the number observed, follow-up, and event definitions. Here, the record gives 2 at risk, but no uncertainty interval or comparative estimate. The counts should therefore be read narrowly as the adverse-event figures recorded, not as a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective, multicenter, open-label, non-interventional, uncontrolled, single-arm study was registered to assess treatment satisfaction among participants with relapsing-remitting multiple sclerosis taking Rebif after discontinuing initial first-line treatment. Its primary outcome was a TSQM v II treatment-satisfaction score at Month 6. The record also identifies other outcome topics and reports the study status as TERMINATED.
It does not establish what satisfaction score participants recorded. No primary outcome value, uncertainty measure, or analysis result is reported in the registry record. Consequently, the magnitude and precision of the primary outcome cannot be described. The listed secondary outcomes likewise do not establish observed results: outcome names are not estimates or evidence of an association.
The design cannot estimate a treatment contrast because there is no comparator. Even a reported satisfaction score would describe the participants contributing data in this study, rather than reveal what the same population would have reported under an alternative strategy. General considerations such as expectations, previous treatment experience, and the open-label design may affect self-reported satisfaction, but the record does not show whether or to what extent they did so.
The safety counts are also limited to their recorded scope: 0 participants with serious adverse events, 0 with other adverse events, and 0 deaths among 2 at risk. These counts do not constitute a comparison or a precise estimate of risk. Taken together, the record supports a description of study purpose, design, enrollment, outcome definitions, status, and recorded adverse-event counts. It does not support a conclusion that Rebif improved, worsened, or had no effect on satisfaction or clinical outcomes.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary question concerns treatment satisfaction, a participant-reported outcome, in a single-arm setting. Such outcomes can capture experiences that are not represented by clinical event counts alone. Their interpretation depends on clear scoring rules, a defined analysis population, and transparent reporting of observed values and uncertainty. The registry describes the questionnaire and the Month 6 outcome population, but does not report the result or the scoring procedure used to derive the named score.
The record also illustrates why study design and outcome reporting need to be read together. A descriptive outcome can be useful for documenting experience in a study population, but an uncontrolled design cannot separate a treatment-associated outcome from other explanations through a direct comparison. The word prospective describes planned observation over time; it does not by itself establish a comparator, randomization, or a causal estimate.
Registry records can also distinguish planned topics from reported findings. This record lists 17 outcome measures overall and has 0 analyses. The named outcomes may help readers understand what investigators intended to assess, but they cannot substitute for estimates, uncertainty intervals, or details of how missing observations and multiple outcomes were handled. These elements are essential to evaluate how much information the results contain.
Finally, the record shows the importance of examining the analysis population rather than assuming it from enrollment. The registry gives an enrollment of 2 and defines the primary population by medication receipt and Month 6 data collection, but does not report the number contributing to that outcome. That gap prevents assessment of the result’s precision and illustrates why transparent participant flow and outcome reporting are statistically important.
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 primary limitation is that no observed value for the primary treatment-satisfaction outcome is reported in the registry record. Without the score or an uncertainty measure, neither its magnitude nor precision can be assessed. The description also does not explain how the responses to the 11 question items were combined into the reported score.
The study is described as uncontrolled and single arm, so it has no comparison group. It cannot directly estimate a difference in satisfaction or other outcomes between Rebif and an alternative. The open-label design is particularly relevant to a participant-reported satisfaction measure; the record does not report any blinding or other method to address possible influences on responses.
The registry enrollment is 2, but the number included in the Month 6 outcome population is not reported. Participant-level outcome availability, attrition, and reasons for missing data are not reported in the registry record. The status is TERMINATED, but the reason for termination and its implications for follow-up are not reported. The recorded dates are 2017-02-09 for study start and 2017-08-25 for primary completion; the record does not provide further context about the termination.
The registry lists 17 outcome measures and 0 analyses. It does not report a statistical analysis plan, multiplicity approach, missing-data method, interim analyses, or sensitivity analyses. The listed secondary outcomes therefore cannot be interpreted as completed analyses or findings. Safety information is limited to the reported counts and does not include further event descriptions or uncertainty estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) — NCT02949908.
- Registry record last updated 2019-01-18; status last verified 2018-07.
- Results first posted 2019-01-18.
- 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
The registry describes NCT02949908 as a Phase IV, prospective, multicenter, open-label, uncontrolled, non-interventional, single-arm study of Rebif in participants with relapsing-remitting multiple sclerosis after discontinuing initial first-line treatment. The recorded enrollment is 2. The listed start date is 2017-02-09, the primary completion date is 2017-08-25, and the status is TERMINATED.
The primary outcome is a TSQM v II treatment-satisfaction score at Month 6. The registry describes the questionnaire as consisting of 11 question items, with responses from 1 to 7. It lists 17 outcome measures overall and reports 0 analyses. No primary outcome estimate or uncertainty measure is reported in the registry record.
The adverse-event record lists 0 participants with serious adverse events, 0 with other adverse events, and 0 deaths among 2 at risk. The study has no comparator, and the registry does not report why it was terminated or how missing data were handled.