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 BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) (NCT00605215), a randomized phase 3 study. The primary outcome is Annualized Rate of Confirmed Relapses.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00605215 |
| Phase | Phase 3 |
| Condition | Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1331 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants had relapsing-remitting multiple sclerosis. The primary analysis population was the intent-to-treat set, defined in the registry record as all randomized participants. Enrollment was 1331.
Intervention
Laquinimod was given as a 0.6 mg capsule orally once daily for 24 months.
Comparator
The main comparison was laquinimod against matching placebo capsules taken orally once daily for 24 months. Avonex® was included as a reference arm, with an injection of 30 micrograms given intramuscularly once weekly for 24 months.
Primary question
The primary question was whether the annualized rate of confirmed relapses differed between laquinimod and placebo from baseline through Month 24. The trial also reported a comparison of placebo with the Avonex® reference arm. These comparisons concern relapse rates estimated using the registry’s specified analysis, rather than a simple count of participants who relapsed.
The record describes a randomized, parallel-group, phase 3 study in participants with relapsing-remitting multiple sclerosis. Its main efficacy question is anchored to a clinically relevant event: a confirmed relapse, defined using both the duration and nature of neurological changes. Avonex® provides a reference comparison in the study, but the record describes that arm as rater-blinded, whereas the laquinimod-placebo comparison was double-blind. Details about how the masking arrangements operated in practice are not reported in the registry record.
3. Trial Design
BRAVO was a randomized, parallel-group phase 3 study with enrollment of 1331. The registry record lists quadruple masking and describes the central laquinimod-placebo comparison as double-blind. It also identifies Avonex® as a rater-blinded reference arm. The record does not explain which groups of people were included in the quadruple masking designation or how masking differed across the reference arm.
The three treatment arms were laquinimod, matching placebo, and Avonex®. Laquinimod was taken orally once daily at 0.6 mg; placebo was taken orally once daily as a capsule matching laquinimod. Avonex® was administered as a 30 microgram intramuscular injection once weekly. Each treatment description specifies a 24-month duration. The study is described as multinational and multicenter in its official title.
The primary outcome was the annualized rate of confirmed relapses from baseline up to Month 24. The primary analysis set included all randomized participants. The registry reports arm estimates for placebo, laquinimod, and Avonex®, followed by negative binomial regression comparisons of placebo with each active arm. It also lists three secondary outcomes: change in the Multiple Sclerosis Functional Composite score, percent change in brain volume, and the number of participants with confirmed progression of Expanded Disability Status Scale scores.
The record lists a start date of 2008-04-24, primary completion on 2011-06-10, and a completed status. The trial’s sample-size justification, allocation ratio, detailed visit schedule, interim analyses, and full statistical analysis plan are not reported in the registry record. The registry also does not explain the handling of treatment discontinuation or deviations from assigned treatment.
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 | Placebo | Laquinimod | Avonex® |
|---|---|---|---|
| STARTED | 450 | 434 | 447 |
| Received at Least 1 Dose of Study Drug | 449 | 433 | 442 |
| COMPLETED | 359 | 353 | 378 |
| NOT COMPLETED | 91 | 81 | 69 |
Reasons for not completing this period:
| Reason | Placebo | Laquinimod | Avonex® |
|---|---|---|---|
| Death | 0 | 0 | 1 |
| Adverse Event | 19 | 21 | 26 |
| Refusal to sign the re-consent form | 8 | 3 | 3 |
| Withdrawal by Subject | 39 | 37 | 27 |
| Request of Primary Care Physician or Investigator | 6 | 4 | 4 |
| Protocol Violation | 3 | 4 | 1 |
| Pregnancy | 8 | 5 | 4 |
| Lost to Follow-up | 8 | 5 | 2 |
| Other than specified | 0 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT analysis set included all randomized participants.
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.
Population: Intent-to-treat (ITT) analysis set included all randomized participants.
| Characteristic | Unit | Placebo | Laquinimod | Avonex® | Total |
|---|---|---|---|---|---|
| Participants analysed | 450 | 434 | 447 | 1331 | |
| Age, Continuous | years | 37.5 (SD 9.5) | 37.0 (SD 9.3) | 38.2 (SD 9.5) | 37.6 (SD 9.5) |
| Sex: Female, Male: Female | Participants | 321 | 282 | 307 | 910 |
| Sex: Female, Male: Male | Participants | 129 | 152 | 140 | 421 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Black of African Heritage | Participants | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized: Black/African American | Participants | 2 | 1 | 4 | 7 |
| Race/Ethnicity, Customized: White | Participants | 443 | 426 | 440 | 1309 |
| Race/Ethnicity, Customized: Hispanic | Participants | 3 | 3 | 1 | 7 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 2 | 1 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Annualized Rate of Confirmed Relapses, measured over Baseline up to Month 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | relapse per year |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the annualized rate of confirmed relapses, measured from baseline up to Month 24 and expressed as relapses per year. A relapse was defined as new neurological abnormalities, or a return of previously observed abnormalities, lasting at least 48 hours. It had to be preceded by an improved neurological state lasting at least 30 days from the onset of the previous relapse. The definition also required observed objective neurological changes: an increase of at least 0.5 in the Expanded Disability Status Scale score, an increase of 1 grade in the score of at least 2 of the 7 Functional Systems, or an increase of 2 grades in the score of 1 Functional System, compared with the previous evaluation.
For the annualized rate, the total number of confirmed relapses during the treatment period was divided by the sum of days on study during that period, then multiplied by the number of days in a year. The registry says the rate was derived using a baseline-adjusted negative binomial regression. Annualizing accounts for differences in observed time on study, allowing the result to be expressed as a rate rather than simply as a total event count.
Relapse rate is useful for summarizing recurrent events: a participant may have more than one confirmed relapse during follow-up. The endpoint therefore reflects the frequency of events over time, not only whether a participant experienced any relapse. It does not, by itself, describe the severity or duration of each event beyond the criteria used to confirm it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
In the posted arm results, the annualized rate was 0.344 relapse per year for placebo, with a 95% confidence interval from 0.291 to 0.406. The laquinimod estimate was 0.283, with a 95% confidence interval from 0.237 to 0.337. The Avonex® estimate was 0.255, with a 95% confidence interval from 0.213 to 0.304. These are arm-level rate estimates; their confidence intervals describe uncertainty around each estimate and are not, by themselves, the formal treatment comparisons.
The registry reports the laquinimod-versus-placebo comparison as a risk ratio of 0.823, with a 95% confidence interval from 0.664 to 1.020 and p = 0.075. The interval includes 1, and the reported p-value is above the conventional 0.05 threshold. The registry’s analysis therefore does not provide strong statistical evidence against the null value of no relative difference for this comparison under that threshold. The point estimate is below 1, but its uncertainty includes values close to no difference and values on either side of it.
For Avonex® versus placebo, the reported risk ratio was 0.741, with a 95% confidence interval from 0.596 to 0.920 and p = 0.007. This interval lies below 1, and the reported p-value is below 0.05. The registry’s negative binomial regression thus reports statistical evidence of a lower relapse rate relative to placebo for this reference-arm comparison. This result should be understood as the trial’s reported comparison, not as a direct comparison between Avonex® and laquinimod.
The three arm estimates are descriptive summaries, while the risk ratios and their confidence intervals are the formal reported comparisons. The distinction matters because a difference between two arm estimates is not itself a test of whether the groups differ. The registry’s comparison model adjusts for baseline, as specified in the primary outcome description; the arm-level confidence intervals do not replace that model-based comparison.
The pattern across estimates is that both active-arm point estimates are lower than the placebo estimate, while the certainty of the reported comparisons differs. Statistical evidence for a difference is not the same as proof of a treatment effect, and a confidence interval conveys a range of estimates compatible with the model and data rather than a guarantee about the true value. The registry record does not report a multiplicity adjustment for the primary comparisons, so the p-values should be read in the context of the stated analyses rather than as evidence that all possible comparisons were accounted for.
9. Statistical Methods Explained
The primary endpoint is a recurrent-event rate. Because participants can experience multiple relapses, a method for event counts is appropriate to the outcome’s structure. The registry identifies negative binomial regression, adjusted for baseline, as the method used to derive the annualized relapse rate. This model estimates a rate while allowing the event-count data to vary more than a simpler count model may accommodate. In general, over-dispersion means that observed counts vary more than a model’s restrictive assumptions expect; allowing for it can produce more realistic uncertainty when such variation is present. The registry does not report diagnostics or further model details, so the adequacy of those assumptions cannot be assessed from this record alone.
A rate ratio compares the estimated event rate in one group with the estimated rate in another. A value of 1 represents equal rates under this measure; values below 1 indicate a lower estimated rate in the first group relative to the comparator, and values above 1 indicate a higher estimated rate. The registry reports risk ratios for placebo comparisons, with confidence intervals and p-values. In this context, interpretation depends on both the point estimate and its uncertainty. A confidence interval that includes 1 is compatible with no relative difference under the model, while a range entirely on one side of 1 is more consistent with a relative difference. Neither interval width nor a p-value alone gives a complete account of clinical importance.
A confidence interval describes uncertainty in an estimate under the analysis assumptions. It is not a range containing a guaranteed proportion of individual outcomes, and it does not account for sources of bias that the analysis does not address. The registry’s primary intervals are reported at 95%. The p-value measures how unusual the observed data, or data more extreme, would be under the null hypothesis and the model; it is not the probability that the null hypothesis is true. Interpretation should therefore consider the effect estimate, the confidence interval, the analysis method, and the trial design together.
The posted secondary continuous-outcome comparisons are recalculated, unadjusted comparisons from arm-level summary statistics. For a continuous measure, a mean difference expresses the difference between group means in the outcome’s own units. Its confidence interval describes uncertainty around that difference. The posted calculations use the reported group means and standard deviations; they are not the same as a trial-specific adjusted model unless the registry explicitly reports such a model. The registry does not list sponsor analyses for these secondary comparisons, so the recalculations should not be mistaken for the trial’s prespecified or adjusted analyses.
For the binary secondary outcome, the recalculated risk difference expresses the difference between the proportions of participants with confirmed progression in the two groups. A negative risk difference indicates a lower observed proportion in the first group than in placebo. The interval describes uncertainty, and the unadjusted p-value tests a comparison without adjustment for other variables or for testing multiple outcomes. This simple comparison does not account for time to progression unless the method explicitly models time; the posted endpoint is a count of participants, and the record does not specify a time-to-event analysis for it.
Planning illustrations based on observed effects are not observed power. The record describes those illustrations as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect set to a stated fraction of the observed effect. Such figures are hypothetical planning aids: they show how the calculated sample size changes under those assumptions. They do not establish the study’s original design rationale, because that justification is not reported in the registry record. They also do not indicate the probability that the completed trial detected an effect.
Unadjusted secondary analyses require particular caution when several outcomes or comparisons are examined. Testing multiple hypotheses increases the chance that at least one result will appear statistically notable by chance. An adjustment can address that issue, but the registry record does not report whether a multiplicity procedure was prespecified or applied. The posted recalculations are therefore best treated as exploratory descriptions of the recorded summary statistics, not as a replacement for a complete statistical analysis plan.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Negative Binomial Regression | Risk Ratio (RR) 0.823 | 0.664 to 1.020 | 0.075 |
| Negative Binomial Regression | Risk Ratio (RR) 0.741 | 0.596 to 0.920 | 0.007 |
The registry reports sponsor analyses for the primary relapse-rate comparisons using negative binomial regression. For laquinimod versus placebo, it reports a risk ratio of 0.823, a 95% confidence interval from 0.664 to 1.020, and p = 0.075. For Avonex® versus placebo, it reports a risk ratio of 0.741, a 95% confidence interval from 0.596 to 0.920, and p = 0.007. These are the trial’s reported primary comparisons and should be distinguished from any simple comparison of arm-level estimates.
The registry record does not report sponsor analyses for the secondary outcomes. The posted secondary comparisons are simple unadjusted recalculations from the summary statistics, so they may not reproduce analyses that used participant-level data, covariate adjustment, or other trial-specific procedures. They should not be presented as the sponsor’s findings. No discrepancy is flagged between the primary results and the posted record, and no recalculation of the primary comparison replaces the sponsor’s reported regression analysis.
For interpretation, the sponsor-reported model-based estimates are the relevant source for the primary endpoint. The recalculated secondary estimates can help describe the recorded group summaries, but they have more limited inferential scope. The registry does not provide enough detail to establish whether the secondary recalculations match the trial’s planned analysis methods.
11. Multiplicity, Missing Data and Analysis Populations
The primary analysis population is described as the intent-to-treat set, including all randomized participants. The record reports arm sizes for the primary endpoint and gives outcome-specific counts for secondary measures. It does not describe the detailed analysis population for each secondary endpoint, explain why denominators differ across outcomes, or report how missing measurements were handled. Reasons for withdrawal, treatment discontinuation, and incomplete follow-up are not reported in the registry record.
The primary outcome description names a baseline-adjusted negative binomial regression. Further details about covariates, model diagnostics, treatment of recurrent events after discontinuation, and sensitivity analyses are not reported. The registry lists two primary comparisons against placebo, but does not describe a multiplicity adjustment or state how the comparisons were prioritized. It also does not report whether interim analyses were conducted. These omissions prevent a full assessment of how the analysis plan addressed repeated testing or potential departures from the assumptions of the primary model.
Three secondary outcomes are posted, and recalculated comparisons are available for some of them. A p-value from an unadjusted secondary comparison does not account for the possibility of chance findings across multiple endpoints or comparisons. Whether an adjustment was planned or used is not reported in the registry record. The secondary results should therefore be interpreted as supportive or exploratory unless a fuller analysis plan establishes a different status.
The sample-size justification and original power assumptions are also not reported. Planning illustrations based on observed effects are hypothetical and are not observed power; they cannot show what the trial was designed to detect or how likely it was to detect the effects that were actually present. Overall, the registry offers the primary analysis population and named primary model, but not enough information to reconstruct the full statistical plan, assess all missing-data assumptions, or determine how multiplicity was handled.
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 |
|---|---|---|---|
| Placebo | 36 | 449 | 8.0% |
| Laquinimod | 31 | 433 | 7.2% |
| Avonex® | 25 | 442 | 5.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 449 |
| Laquinimod | 1 of 433 |
| Avonex® | 1 of 442 |
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 |
|---|---|
| Placebo | 146 of 449 |
| Laquinimod | 158 of 433 |
| Avonex® | 286 of 442 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Laquinimod | Avonex® |
|---|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | 2 of 449 | 3 of 433 | 0 of 442 |
| Chest pain | General disorders | 0 of 449 | 2 of 433 | 1 of 442 |
| Cholelithiasis | Hepatobiliary disorders | 1 of 449 | 1 of 433 | 1 of 442 |
| Pneumonia | Infections and infestations | 1 of 449 | 1 of 433 | 1 of 442 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 1 of 449 | 1 of 433 | 1 of 442 |
| Hysterectomy | Surgical and medical procedures | 2 of 449 | 1 of 433 | 0 of 442 |
| Deep vein thrombosis | Vascular disorders | 1 of 449 | 0 of 433 | 2 of 442 |
| Acute myocardial infarction | Cardiac disorders | 0 of 449 | 0 of 433 | 2 of 442 |
| Abdominal pain | Gastrointestinal disorders | 1 of 449 | 0 of 433 | 1 of 442 |
| Pulmonary tuberculosis | Infections and infestations | 0 of 449 | 1 of 433 | 1 of 442 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Laquinimod | Avonex® |
|---|---|---|---|---|
| Influenza like illness | General disorders | 7 of 449 | 5 of 433 | 206 of 442 |
| Headache | Nervous system disorders | 53 of 449 | 54 of 433 | 60 of 442 |
| Nasopharyngitis | Infections and infestations | 35 of 449 | 40 of 433 | 29 of 442 |
| Upper respiratory tract infection | Infections and infestations | 36 of 449 | 34 of 433 | 22 of 442 |
| Back pain | Musculoskeletal and connective tissue disorders | 32 of 449 | 44 of 433 | 15 of 442 |
| Influenza | Infections and infestations | 28 of 449 | 27 of 433 | 20 of 442 |
| Pyrexia | General disorders | 7 of 449 | 6 of 433 | 52 of 442 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 18 of 449 | 24 of 433 | 18 of 442 |
Serious events with the highest arm-level rate: multiple sclerosis relapse (0.7%), chest pain (0.5%), osteoarthritis (0.5%), acute myocardial infarction (0.5%), deep vein thrombosis (0.5%).
The registry lists serious adverse event counts among participants at risk for each arm: 36 of 449 for placebo, 31 of 433 for laquinimod, and 25 of 442 for Avonex®. It separately reports other adverse event counts and deaths. These are descriptive safety counts; they do not by themselves establish that an event was caused by a study treatment or support a causal comparison between groups. The record does not provide adjusted safety analyses or details of event exposure time in this summary.
The serious-event terms listed include multiple sclerosis relapse at 0.7%, chest pain at 0.5%, osteoarthritis at 0.5%, acute myocardial infarction at 0.5%, deep vein thrombosis at 0.5%, and hepatic enzyme increased at 0.4%. The record does not clarify in this summary whether these listed percentages are pooled across arms or how event terms were selected. Counts and percentages should therefore be read as registry safety reporting, not as comparative estimates of treatment risk.
One death is listed in the laquinimod arm and one in the Avonex® arm; no deaths are listed for placebo. These counts are descriptive and do not establish cause. The registry record does not provide further details about the deaths in this summary.
13. What the Result Does, and Does Not, Mean
The primary results describe estimated rates of confirmed relapses during the treatment period, with the reported model comparing each active arm against placebo. For laquinimod, the registry’s confidence interval includes the null value for a rate ratio and its p-value is above 0.05. For Avonex®, the reported interval is below the null value and the p-value is below 0.05. These findings describe the statistical evidence from the reported analyses; they do not, by themselves, establish the size or importance of any effect for an individual participant.
A group-level rate cannot predict whether a particular participant will experience a relapse. Nor does the primary endpoint capture every dimension of multiple sclerosis, such as all functional changes, imaging findings, treatment burden, or adverse effects. The secondary outcomes add different measurements, but their recalculated comparisons are unadjusted and should be interpreted cautiously. Taken together, these analyses do not provide a complete assessment of all benefits and harms.
Statistical significance is not a measure of clinical importance. A confidence interval communicates uncertainty under the analysis assumptions, while a p-value addresses compatibility with a null hypothesis under a model. Neither removes uncertainty from the study design, missing information, outcome measurement, or reporting. The registry does not report enough information to assess the full multiplicity strategy, missing-data approach, or prespecified status of every secondary analysis.
The reference-arm comparison also should not be read as a direct test of laquinimod against Avonex®. The reported primary comparisons are each against placebo. No head-to-head primary comparison between the active arms is reported in the registry record. The results therefore address the stated placebo comparisons, not every possible treatment contrast or a broader claim about comparative effectiveness.
14. Why This Trial Matters Statistically
BRAVO illustrates why the choice of estimand and model matters in a clinical trial with recurrent events. The primary outcome is not simply the proportion of participants who had any relapse: it is an annualized rate that accounts for repeated confirmed events and time on study. Negative binomial regression is the stated analysis method, with baseline adjustment. Reading the model-based risk ratios alongside arm-level rates helps distinguish a descriptive summary from a formal comparison.
The record also illustrates how different endpoints answer different questions. A relapse rate, a functional composite score, brain-volume change, and confirmed disability progression are not interchangeable measures. The secondary outcomes provide breadth, but their unadjusted recalculations and uncertain multiplicity status mean that they should not be treated as equally definitive evidence. This is a useful reminder that statistical interpretation depends on endpoint hierarchy, analysis method, and the number of questions examined.
Finally, BRAVO shows why registry results need to be read with attention to reporting scope. The primary model and intent-to-treat population are identified, but key details about missing data, multiplicity, interim analyses, and sample-size justification are not reported in the registry record. Those gaps limit how fully an external reader can reconstruct or evaluate the planned analysis. The reported estimates remain informative, but their interpretation should stay within the comparisons and methods that the record actually documents.
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 gives limited detail about the primary negative binomial model beyond baseline adjustment. It does not report the covariates included, model diagnostics, or sensitivity analyses. The record also does not describe the planned handling of participants with incomplete follow-up, treatment discontinuation, or missing outcome data. These omissions make it difficult to assess whether the reported estimates are sensitive to analysis choices.
The record identifies quadruple masking while also describing a double-blind laquinimod-placebo comparison and a rater-blinded Avonex® reference arm. It does not explain the practical masking arrangements or how masking was maintained in each arm. The record also does not report the randomization ratio, allocation concealment procedures, or the sample-size justification. These details would help readers evaluate the design and the potential for bias.
The posted secondary comparisons are unadjusted recalculations from summary statistics, not sponsor-reported analyses. They cannot account for participant-level covariates or missing-data methods that might have been used in the trial analysis. The record does not report a multiplicity plan for the primary or secondary comparisons, and it does not state whether interim analyses were performed. Safety counts are also descriptive in the summary and do not establish causality or provide a full comparative safety analysis.
These are limitations of the information reported in the registry record, not proof that the study lacked procedures or analyses. Additional protocol or analysis documentation could address some of these questions, but such details are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) — NCT00605215.
- Registry record last updated 2022-04-21; status last verified 2022-03.
- Results first posted 2022-04-21.
- 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
NCT00605215 is the completed BRAVO phase 3 randomized, parallel-group study of laquinimod, placebo, and a rater-blinded Avonex® reference arm in participants with relapsing-remitting multiple sclerosis. Enrollment was 1331. The listed study start was 2008-04-24, and primary completion was 2011-06-10.
The primary endpoint was annualized confirmed relapse rate from baseline up to Month 24, analyzed using baseline-adjusted negative binomial regression in an intent-to-treat population of all randomized participants. The registry reports comparisons of laquinimod versus placebo and Avonex® versus placebo. Three secondary outcomes are also listed, with unadjusted recalculations available for their posted summary statistics.
The registry record does not report the full statistical analysis plan, sample-size justification, multiplicity procedure, interim analyses, or detailed missing-data methods. These reporting limits qualify interpretation of the secondary results and the completeness of an external assessment of the trial analysis.