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 Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (NCT02792218), a randomized phase 3 study. The primary outcome is Annualized Relapse Rate (ARR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02792218 |
| Phase | Phase 3 |
| Condition | Relapsing Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 930 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsing multiple sclerosis were eligible for the trial. The primary endpoint analysis used the full analysis set. The registry record does not give further eligibility details in the record summarized for these results, so the population should be understood at the level reported rather than extended to other forms of multiple sclerosis or to people outside the trial.
Intervention
The intervention was ofatumumab 20 mg by subcutaneous injection, given on days 1, 7, and 14, at week 4, and every 4 weeks thereafter. Participants also took a teriflunomide-matching placebo capsule once daily. This double-dummy approach meant that the assigned treatment groups followed both an injection schedule and a capsule schedule.
Comparator
The comparator was teriflunomide 14 mg as an oral capsule once daily, together with subcutaneous injections matching placebo ofatumumab on the corresponding schedule. The comparison therefore concerns the assigned treatment regimens, including their matching placebos, rather than a comparison of active treatment with no treatment.
Primary question
The primary question was whether the annualized rate of confirmed relapse differed between the assigned groups from baseline up to 2.5 years. A confirmed relapse required a clinically relevant change on the Expanded Disability Status Scale, assessed by an independent rater, against the previous rating that did not occur during a relapse. The registry reports a negative binomial regression comparison of the relapse rates. The result describes the trial's endpoint and analysis; it is not, by itself, a conclusion about every possible benefit, harm, or outcome.
3. Trial Design
This was a phase 3, randomized, parallel-group trial of ofatumumab versus teriflunomide in participants with relapsing multiple sclerosis. The registry describes the masking as quadruple and the study as double-blind and double-dummy. The registry record does not identify in the results which specific roles were masked, or give further details of the randomization sequence or allocation concealment.
The trial enrolled 930 participants. The primary endpoint was analyzed in the full analysis set, with 454 participants in the ofatumumab group and 451 in the teriflunomide group contributing to the reported arm-level endpoint. The registry record does not explain the accounting between enrollment and these endpoint group sizes, so no reason for that difference should be inferred from the figures alone.
Participants assigned to ofatumumab received 20 mg by subcutaneous injection on days 1, 7, and 14, at week 4, and every 4 weeks thereafter, along with a matching oral placebo capsule once daily. Participants assigned to teriflunomide received a 14 mg oral capsule once daily and matching placebo injections on the corresponding schedule. This design allowed the treatment groups to follow both sets of procedures while maintaining masking.
The study status is completed. Its start date is 2016-09-20, and its primary completion date is 2019-07-05. The registry record describes the comparison and broad design, but details such as the randomization method, treatment adherence, and the operational masking procedures are 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.
Before assignment: A total of 1277 patients were screened, of whom 927 patients were randomized into the study.
Overall Study
| Stage | OMB 20 mg | TER 14 mg |
|---|---|---|
| STARTED | 465 | 462 |
| COMPLETED | 416 | 381 |
| NOT COMPLETED | 49 | 81 |
Reasons for not completing this period:
| Reason | OMB 20 mg | TER 14 mg |
|---|---|---|
| Patient/guardian decision | 15 | 42 |
| Adverse Event | 15 | 14 |
| Lost to Follow-up | 10 | 5 |
| Lack of Efficacy | 1 | 12 |
| Physician Decision | 4 | 4 |
| Protocol deviation | 3 | 2 |
| New therapy for study indication | 0 | 1 |
| Non-compliance with study treatment | 0 | 1 |
| Pregnancy | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Full analysis set
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 | OMB 20 mg | TER 14 mg | Total |
|---|---|---|---|---|
| Participants analysed | 465 | 462 | 927 | |
| Age, Continuous | Years | 38.9 (SD 8.77) | 37.8 (SD 8.95) | 38.4 (SD 8.87) |
| Sex: Female, Male: Female | Participants | 318 | 317 | 635 |
| Sex: Female, Male: Male | Participants | 147 | 145 | 292 |
| Race/Ethnicity, Customized: Asian | Participants | 15 | 16 | 31 |
| Race/Ethnicity, Customized: Black or African American | Participants | 15 | 20 | 35 |
| Race/Ethnicity, Customized: White | Participants | 411 | 412 | 823 |
| Race/Ethnicity, Customized: Other | Participants | 22 | 14 | 36 |
| Race/Ethnicity, Customized: Unknown | Participants | 2 | 0 | 2 |
| Number of relapses in the past 12 months prior to screening | Number of relapses | 1.2 (SD 0.63) | 1.3 (SD 0.69) | 1.2 (SD 0.66) |
| Expanded Disability Status Scale (EDSS) | Score on a scale | 2.97 (SD 1.357) | 2.94 (SD 1.355) | 2.96 (SD 1.356) |
| Number of Gd-enhancing T1 lesions | T1 lesions | 1.7 (SD 4.93) | 1.2 (SD 2.58) | 1.5 (SD 3.95) |
6. Primary Endpoint
The registry lists the primary outcome as Annualized Relapse Rate (ARR), measured over Baseline up to 2.5 years.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | number of relapses in a year |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was annualized relapse rate, or ARR, from baseline up to 2.5 years. It measures the rate of confirmed relapses per participant-year, rather than simply the proportion of participants who experienced at least one relapse. The registry defines ARR by dividing the total number of confirmed relapses in a treatment group by the total participant-years of time in study.
A relapse counted for this endpoint had to be accompanied by a clinically relevant change on the Expanded Disability Status Scale, assessed by an independent EDSS rater. The required change was an increase of at least 0.5 points on the EDSS, or an increase of 1 point on two functional scores or 2 points on one functional score, excluding changes involving the bowel/bladder or cerebral functional system. The change was assessed against the previous rating that did not occur during a relapse.
Using a rate accounts for the time participants contributed to follow-up. This is useful when participants have different amounts of observation, because the measure relates the relapse count to time under observation. It remains a defined trial outcome: it does not describe every symptom, disability change, or aspect of participants' experience.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The reported ARR was 0.11 in the OMB 20 mg group, with a 95% confidence interval from 0.09 to 0.14. In the TER 14 mg group, the reported ARR was 0.22, with a 95% confidence interval from 0.18 to 0.26. These arm-level estimates describe confirmed relapse rates per year over the stated follow-up period. Their confidence intervals express uncertainty in the estimates; they are not a range of individual participants' relapse counts.
The registry's primary comparison used negative binomial regression and reported a rate ratio of 0.495, with a 95% confidence interval from 0.375 to 0.655 and p < 0.001. A rate ratio compares the modeled rates, with values below 1 indicating a lower modeled rate in the numerator group than in the comparison group. The reported estimate and interval are consistent with a lower modeled ARR for OMB 20 mg relative to TER 14 mg in this trial. The p-value describes how incompatible the observed data are with the model's null comparison, under the assumptions of that analysis; it is not the probability that the null hypothesis is true.
The interval conveys more than the p-value alone: it gives a range of rate-ratio values compatible with the data under the analysis. It does not encompass every source of uncertainty, including questions about generalizability, missing observations, or analysis choices that are not described in the registry record. The arm-level confidence intervals and the rate-ratio confidence interval answer related but distinct questions, so their endpoints should not be compared as if they were the same contrast.
The endpoint's definition matters for interpretation. Only relapses meeting the specified confirmation criteria count toward ARR. The reported estimate therefore concerns confirmed relapses under that definition, not all reported symptoms or every possible measure of disease activity. It also summarizes events over participant-time rather than stating the chance that any one participant will experience a relapse.
The result is one finding from a trial that also listed disability and MRI outcomes. The registry record names those outcome areas, but values for most of the listed secondary measures are not reported in the registry record in the information summarized for these results. The primary endpoint should therefore be read as a focused result rather than as a complete account of every outcome assessed.
9. Statistical Methods Explained
The primary comparison was estimated with a negative binomial regression model. ARR is a count-based rate: the endpoint uses the number of confirmed relapses relative to participant-years of follow-up. A regression model can compare such rates while representing the observed count data. The registry gives the model family and the resulting rate ratio, confidence interval, and p-value, but the model's other specifications are not reported in the registry record. In particular, the registry record does not state which covariates were included or give further details of the model implementation.
Why use a rate ratio?
A rate ratio expresses one modeled event rate relative to another. A value of 1 would indicate equal modeled rates; a value below 1 indicates a lower rate in the numerator group, and a value above 1 indicates a higher rate. This is a general interpretation of the measure, not an additional result. The reported rate ratio of 0.495 compares the OMB 20 mg group with the TER 14 mg group. Its confidence interval, 0.375 to 0.655, describes uncertainty in that relative-rate estimate under the reported analysis.
Why a negative binomial model?
General statistical context: count outcomes can vary more between participants than a simpler count model expects. This is called over-dispersion. A negative binomial model allows greater variability in counts than a Poisson model, and can therefore be useful for count outcomes with over-dispersion. That general rationale does not establish which diagnostics or model checks were performed in this trial. Such details are not reported in the registry record.
Because ARR is defined using participant-years, the time participants contribute to observation is relevant to the rate. The registry defines the endpoint using total relapses divided by total participant-years. It does not report enough model detail to specify how time was represented within the regression or whether any additional adjustments were used. Those elements should not be inferred from the name of the model alone.
What do the confidence intervals express?
A confidence interval describes the precision of an estimate under the statistical method used. In general, a 95% confidence interval is generated by a procedure that would cover the target parameter in 95% of repeated samples if the model assumptions and sampling process held. It is not a statement that there is a 95% probability that this particular interval contains the true value. The arm-level ARR intervals describe uncertainty around each group's rate estimate, while the interval for the rate ratio describes uncertainty around the comparison.
A p-value is a measure of how surprising data at least as incompatible with the null comparison would be under that null and the analysis assumptions. The reported p < 0.001 is not a measure of the size or clinical importance of the difference, and it does not describe the probability that the result arose by chance. The estimated rate ratio and its interval are needed to understand the direction and precision of the comparison.
How to read the secondary comparison and planning illustrations
The registry also reports a secondary binary outcome, the percentage of participants with a confirmed relapse. A binary outcome records whether a participant met the endpoint, rather than counting events relative to participant-time. The recalculated contrast for that outcome is an unadjusted comparison based on posted summary statistics. General statistical context: unadjusted comparisons do not account for covariates or other design features unless those are explicitly incorporated. They should not be treated as interchangeable with the primary negative binomial model.
Planning illustrations use assumed effect sizes and specified statistical assumptions to show how participant counts might relate to power. They are not observed power, do not show what the trial was designed to detect, and do not replace the trial's own analysis. The stated illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with effects set as fractions of the observed effect. The registry record does not report that these assumptions were the trial's original design assumptions or provide the original sample-size justification.
For the secondary binary comparison, the posted planning values describe participants per arm for 80% power and participants per arm for 90% power at the stated fractions of the observed effect. These are planning illustrations only. They are especially sensitive to the assumed effect: a smaller assumed effect requires a larger planned sample under the illustration's assumptions. No conclusion about the trial's observed power follows from these values.
What is not specified
The registry reports 17 analyses and 30 outcome measures, but the available record does not fully describe the statistical analysis plan. Covariate adjustment, handling of missing outcome data, sensitivity analyses, model diagnostics, and any interim analyses are not reported in the registry record. The absence of those details limits independent assessment of the analysis choices; it does not establish that a particular method was or was not used.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| negative binomial regression model | rate ratio 0.495 | 0.375 to 0.655 | < 0.001 |
The registry reports the primary comparison as a negative binomial regression analysis, with a rate ratio of 0.495, a 95% confidence interval from 0.375 to 0.655, and p < 0.001. The arm-level ARR estimates and confidence intervals are also reported. These are the posted primary results and are the appropriate basis for describing the trial's primary analysis.
No simple unadjusted recalculation of the primary two-group comparison is available in the reported recalculated results. The registry identifies the endpoint as a continuous measure for the recalculation process and records that values were missing or not estimable for a two-arm comparison. This does not contradict the sponsor's reported model analysis: it means a separate, simple recalculation is not available to compare against that model result.
For the secondary percentage-of-participants outcome, an unadjusted recalculation is available, while the registry lists no sponsor-reported analysis for that outcome in the information. That secondary calculation is a different analysis of a different endpoint and should not be used as a replacement for the sponsor's primary regression result. The discrepancy indicator is false. If a discrepancy were present, the sponsor's own analysis would take precedence; there is no such discrepancy indicated for these results.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 30 outcome measures and 17 analyses. When a study examines many outcomes or makes multiple statistical comparisons, multiplicity becomes relevant: the more opportunities there are to find a small p-value, the greater the possibility of a chance finding somewhere among the results. Statistical strategies can address this, for example by adjusting significance thresholds or by specifying a testing sequence. The registry record does not report whether either approach, or another multiplicity procedure, was used.
The reported primary comparison is the principal result for interpreting the trial's stated primary endpoint. The record does not provide enough detail to determine how the primary endpoint was protected from other testing, whether outcomes were hierarchically ordered, or whether the 17 analyses include only planned comparisons. These details are not reported in the registry record. In the absence of a documented multiplicity strategy, secondary p-values should not be treated as if each were an isolated confirmatory test.
The primary analysis population is identified as the full analysis set. The registry record summarized for these results does not give the full analysis-set definition, describe how participants were handled after randomization, or say how missing data were handled. It does not report whether values were imputed, whether participants with incomplete follow-up were included in particular analyses, or whether sensitivity analyses assessed the impact of missingness. Those omissions prevent a complete appraisal of how missing outcomes may have affected estimates.
Details about interim analyses, stopping rules, and the statistical analysis plan are also not reported in the registry record. The absence of those details should be treated as uncertainty about reporting, not as evidence that interim analyses or other procedures did or did not occur. The trial's completion status and posted primary estimate do not resolve these methodological questions.
The sample-size illustrations are calculations based on the observed effect and stated assumptions, not evidence of the original design rationale. The registry record does not report the original sample-size justification. Those illustrations also do not establish observed power; the precision of the actual estimate is better conveyed by its confidence interval. This distinction is important when interpreting secondary outcomes that may have different event frequencies or measurement variability.
12. 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 |
|---|---|---|---|
| OMB 20mg | 51 | 465 | 11.0% |
| TER 14mg | 39 | 462 | 8.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| OMB 20mg | 0 of 465 |
| TER 14mg | 0 of 462 |
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 |
|---|---|
| OMB 20mg | 282 of 465 |
| TER 14mg | 308 of 462 |
Most frequent serious adverse event terms
| Event term | Organ system | OMB 20mg | TER 14mg |
|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | 1 of 465 | 4 of 462 |
| Appendicitis | Infections and infestations | 3 of 465 | 1 of 462 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 465 | 1 of 462 |
| Vertigo | Ear and labyrinth disorders | 2 of 465 | 0 of 462 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 465 | 2 of 462 |
| Gastroenteritis | Infections and infestations | 2 of 465 | 0 of 462 |
| Injection related reaction | Injury, poisoning and procedural complications | 2 of 465 | 0 of 462 |
| Suicidal ideation | Psychiatric disorders | 2 of 465 | 0 of 462 |
| Nephrolithiasis | Renal and urinary disorders | 0 of 465 | 2 of 462 |
| Menorrhagia | Reproductive system and breast disorders | 1 of 465 | 1 of 462 |
Most frequent non-serious adverse event terms
| Event term | Organ system | OMB 20mg | TER 14mg |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 82 of 465 | 69 of 462 |
| Injection related reaction | Injury, poisoning and procedural complications | 74 of 465 | 77 of 462 |
| Upper respiratory tract infection | Infections and infestations | 47 of 465 | 73 of 462 |
| Headache | Nervous system disorders | 59 of 465 | 53 of 462 |
| Alopecia | Skin and subcutaneous tissue disorders | 27 of 465 | 65 of 462 |
| Diarrhoea | Gastrointestinal disorders | 24 of 465 | 64 of 462 |
| Fatigue | General disorders | 46 of 465 | 39 of 462 |
| Urinary tract infection | Infections and infestations | 41 of 465 | 41 of 462 |
| Back pain | Musculoskeletal and connective tissue disorders | 35 of 465 | 34 of 462 |
| Injection site reaction | General disorders | 41 of 465 | 26 of 462 |
Serious events with the highest arm-level rate: multiple sclerosis relapse (0.9%), appendicitis (0.6%), abdominal pain upper (0.4%), nephrolithiasis (0.4%), pulmonary embolism (0.4%).
The registry reports serious adverse events for both groups: 51 among 465 participants at risk in the OMB 20mg group and 39 among 462 at risk in the TER 14mg group. It reports no deaths in either group. These counts describe the posted serious adverse event data; they do not, on their own, establish whether any event was caused by assigned treatment or whether the difference between group counts is statistically meaningful.
The registry also lists 282 participants in the OMB 20mg group and 308 in the TER 14mg group under other adverse events. The record does not provide, in the figures, the definitions needed to interpret the relationship between this category and serious events, or the complete event-level context. The listed serious-event terms include multiple sclerosis relapse at 0.9%, appendicitis at 0.6%, and abdominal pain upper, nephrolithiasis, pulmonary embolism, and vertigo each at 0.4%. The record does not specify the denominator or group attribution for those term percentages in the summarized data, so they should not be assigned to an arm.
Adverse event counts are descriptive. They are not a substitute for assessment of event severity, timing, exposure, attribution, or comparative uncertainty, details of which are not fully reported in the registry record.
13. What the Result Does, and Does Not, Mean
The primary result describes a lower modeled annualized rate of confirmed relapses in the OMB 20 mg group relative to the TER 14 mg group during the trial's stated follow-up, with the reported rate ratio and confidence interval conveying the estimated relative contrast and its precision. It is evidence about this endpoint, in the participants analyzed under the trial's definition and methods. It should not be expanded into a claim about every clinical outcome.
ARR is a group-level rate based on relapse counts and participant-years. It is not the same as the proportion of participants who experienced at least one relapse, and it does not predict an individual participant's future course. The secondary percentage outcome addresses whether participants experienced a confirmed relapse, while disability and MRI measures represent other outcome domains. Missing results for most named secondary outcomes mean that their relationship to the primary finding cannot be assessed from the registry record.
The confidence interval gives information about statistical precision under the analysis assumptions, but it does not remove uncertainty about the population to which the findings may apply. The registry record does not provide all details about eligibility, missing data, model specifications, or multiplicity. Those limitations matter when assessing robustness and generalizability. A small p-value is not a measure of clinical importance, and statistical evidence for a difference does not settle how that difference should be weighed in a clinical context.
The safety counts are also descriptive and do not establish causation. The registry's posted event totals and selected terms offer a limited account of reported safety outcomes; they do not provide every detail needed to compare risks. Overall, these results describe a randomized trial comparison and its reported estimates. They do not alone establish what will happen for an individual, resolve unreported outcomes, or answer questions beyond the measures and follow-up assessed.
14. Why This Trial Matters Statistically
This trial illustrates why endpoint scale and analysis method need to be read together. The primary outcome is not simply the number of participants with a relapse; it is a rate using relapse counts and participant-years. The negative binomial regression result compares those rates, while a secondary binary outcome addresses the proportion of participants meeting a relapse criterion. Both can be informative, but they answer different questions and should not be conflated.
The distinction between arm-level estimates and a comparative estimate is also central. The ARR values summarize each group, whereas the rate ratio expresses the modeled contrast between groups. Its confidence interval communicates uncertainty about that contrast. Reading the model estimate alongside its interval is more informative than relying on a p-value alone, while the p-value should not be mistaken for effect size, clinical importance, or certainty that a hypothesis is true.
The registry record also demonstrates how interpretation depends on reporting completeness. It names disability and MRI outcomes and records multiple analyses, but the available results do not establish the pattern across those endpoints or describe a multiplicity strategy. A reader can interpret the primary result while still recognizing that the broader outcome picture and some analysis decisions are not available in the record.
Finally, the planning illustrations are distinct from the study's actual design rationale and from observed evidence. They can clarify how assumptions about the effect size and power translate into participant-count planning, but they cannot be used to infer the trial's original target or observed power. Keeping those statistical roles separate helps prevent planning calculations from being mistaken for trial findings.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report several details needed for a full independent assessment of the primary model, including covariates, diagnostics, and other implementation choices. The negative binomial model is named, but its full specification is not given. The record also does not describe the original sample-size justification, any interim analyses, or the complete statistical analysis plan.
Although the primary population is identified as the full analysis set, the record does not give its operational definition or explain the difference between enrollment and the endpoint group sizes. The handling of missing data, incomplete follow-up, and sensitivity analyses is not reported. Consequently, the degree to which these issues could affect the estimate cannot be judged from the posted details alone.
The registry names multiple secondary outcomes, but values for most of the disability and MRI measures are not reported in the registry record in the information summarized for these results. The multiplicity approach is also not reported. This limits conclusions about whether secondary outcomes align with the primary result and how confidently individual secondary findings should be interpreted.
The trial's reported primary endpoint focuses on confirmed relapses under a specific EDSS-based definition and covers baseline up to 2.5 years. It does not represent all disease manifestations or longer-term outcomes. The summarized safety data provide event counts and selected serious-event terms, but not enough information to establish causality, compare event timing, or fully characterize event-level severity and exposure. These limitations concern the scope and completeness of the available registry reporting; they do not by themselves show that the trial's analysis was invalid.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis — NCT02792218.
- Registry record last updated 2021-10-01; status last verified 2021-09.
- Results first posted 2020-10-19.
- 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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19. Record Summary
NCT02792218 is a completed phase 3 randomized, quadruple-masked, parallel-group trial comparing ofatumumab with teriflunomide in participants with relapsing multiple sclerosis. The trial enrolled 930 participants. The primary endpoint was annualized relapse rate from baseline up to 2.5 years, analyzed in the full analysis set with a negative binomial regression model.
The reported primary rate ratio was 0.495, with a 95% confidence interval from 0.375 to 0.655 and p < 0.001. The registry also lists disability, MRI, relapse, and safety outcomes. Results for most named secondary measures and several statistical-plan details are not reported in the registry record, limiting assessment of the full outcome pattern and analysis procedures.