Trial · NCT00420212
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
NCT00420212, Phase 3, Completed, Biogen; results first posted 2014-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis. Trials, record NCT00420212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00420212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
- NCT number
- NCT00420212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,234 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- BG00012, Placebo
- First posted
- 2007-01-11
- Last updated
- 2015-01-26
- Results first posted
- 2014-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Relapsed | 2 years | A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution. |
| Secondary | Number of New or Newly Enlarging T2 Hyperintense Lesions | 2 years | The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume |
| Secondary | Number of Gadolinium-enhancing T1-weighted Lesions | 2 years | The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group. |
| Secondary | Number of Subjects With Gadolinium (Gd)-Enhancing Lesions | 2 years | Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions" |
| Secondary | Annualized Relapse Rate | 2 years | A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (≤ 2.0 vs. \>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment. |
| Secondary | Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | 2 years | The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Relapsed | 2 years | The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis. | Proportion of subjects,confirmed relapse | NUMBER |
| SECONDARY | Number of New or Newly Enlarging T2 Hyperintense Lesions | 2 years | Of the 540 subjects included in the MRI cohort, 469 subjects (165 placebo, 152 BG00012 BID, 152 BG00012 TID) had post-baseline T2 data and were included in the analysis. Missing data before the use of alternative MS medications and visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption. | Number of lesions | MEAN |
| SECONDARY | Number of Gadolinium-enhancing T1-weighted Lesions | 2 years | Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption | Number of lesions | MEAN |
| SECONDARY | Number of Subjects With Gadolinium (Gd)-Enhancing Lesions | 2 years | Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption | Number of subjects | NUMBER |
| SECONDARY | Annualized Relapse Rate | 2 years | The ITT population was defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis. | Relapses per year | MEAN |
| SECONDARY | Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | 2 years | The analysis population consisted of the ITT population (all subjects who were randomized and received at least 1 dose of study medication) who had a baseline EDSS assessment. Analysis were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication. | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Relapsed | Placebo | 0.461 | Proportion of subjects,confirmed relapse | ||
| Proportion of Subjects Relapsed | BG00012 240 mg Twice Daily (BID) | 0.270 | Proportion of subjects,confirmed relapse | ||
| Proportion of Subjects Relapsed | BG00012 240 mg 3 Times Daily (TID) | 0.260 | Proportion of subjects,confirmed relapse | ||
| Number of New or Newly Enlarging T2 Hyperintense Lesions | Placebo | 17.0 | 95% Confidence Interval 12.9 to 22.4 | Number of lesions | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | BG00012 240 mg BID | 2.6 | 95% Confidence Interval 2.0 to 3.5 | Number of lesions | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | BG00012 240 mg TID | 4.4 | 95% Confidence Interval 3.2 to 5.9 | Number of lesions | |
| Number of Gadolinium-enhancing T1-weighted Lesions | Placebo | 1.8 | Standard Deviation 4.15 | Number of lesions | |
| Number of Gadolinium-enhancing T1-weighted Lesions | BG00012 240 mg BID | 0.1 | Standard Deviation 0.63 | Number of lesions | |
| Number of Gadolinium-enhancing T1-weighted Lesions | BG00012 240 mg TID | 0.5 | Standard Deviation 1.73 | Number of lesions | |
| Number of Subjects With Gadolinium (Gd)-Enhancing Lesions | Placebo | 0 lesions | 103 | Number of subjects |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 408 | |
| Overall Study | STARTED | BG00012 240 mg Twice Daily (BID) | 410 | |
| Overall Study | STARTED | BG00012 240 mg 3 Times Daily (TID) | 416 | |
| Overall Study | COMPLETED | Placebo | 317 | |
| Overall Study | COMPLETED | BG00012 240 mg Twice Daily (BID) | 315 | |
| Overall Study | COMPLETED | BG00012 240 mg 3 Times Daily (TID) | 320 | |
| Overall Study | NOT COMPLETED | Placebo | 91 | |
| Overall Study | NOT COMPLETED | BG00012 240 mg Twice Daily (BID) | 95 | |
| Overall Study | NOT COMPLETED | BG00012 240 mg 3 Times Daily (TID) | 96 |
Source ClinicalTrials.gov
Adverse events672
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 101 | 408 | |
| other | NASOPHARYNGITIS | Infections and infestations | BG00012 240 mg Twice Daily (BID) | 108 | 410 | |
| other | NASOPHARYNGITIS | Infections and infestations | BG00012 240 mg 3 Times Daily (TID) | 109 | 416 | |
| other | NASOPHARYNGITIS | Infections and infestations | Total BG00012 | 217 | 826 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 53 | 408 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | BG00012 240 mg Twice Daily (BID) | 63 | 410 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | BG00012 240 mg 3 Times Daily (TID) | 51 | 416 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Total BG00012 | 114 | 826 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 53 | 408 | |
| other | URINARY TRACT INFECTION | Infections and infestations | BG00012 240 mg Twice Daily (BID) | 55 | 410 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | BG00012 240 mg Twice Daily (BID) | ||
| Total, all-cause mortality | BG00012 240 mg 3 Times Daily (TID) | ||
| Total, all-cause mortality | Total BG00012 | ||
| Total, other adverse events | Placebo | 384 | 408 |
| Total, other adverse events | BG00012 240 mg Twice Daily (BID) | 394 | 410 |
| Total, other adverse events | BG00012 240 mg 3 Times Daily (TID) | 393 | 416 |
| Total, other adverse events | Total BG00012 | 787 | 826 |
| Total, serious adverse events | Placebo | 86 | 408 |
| Total, serious adverse events | BG00012 240 mg Twice Daily (BID) | 74 | 410 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00420212
GET https://conductscience.org/api/trials/v1/NCT00420212/results?page=2