Trial · NCT00451451
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
NCT00451451, 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 Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis. Trials, record NCT00451451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00451451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
- NCT number
- NCT00451451
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,417 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- BG00012, Placebo, Glatiramer Acetate
- First posted
- 2007-03-23
- Last updated
- 2015-01-26
- Results first posted
- 2014-06-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment. |
| 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 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume. |
| Secondary | Number of New T1 Hypointense Lesions | 2 years | The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume. |
| Secondary | 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 neurologic 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 | Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | 2 years | EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. 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 ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks 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
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate | 2 years | The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. 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 | Number of New or Newly Enlarging T2 Hyperintense Lesions | 2 years | Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption. | Number of lesions | MEAN |
| SECONDARY | Number of New T1 Hypointense Lesions | 2 years | Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption | Number of lesions | MEAN |
| SECONDARY | 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 treatment. Among subjects who switched to an alternative therapy for MS, 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 | Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | 2 years | The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses 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 group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate | Placebo | 0.401 | 95% Confidence Interval 0.329 to 0.488 | Relapses Per Year | |
| Annualized Relapse Rate | BG00012 240 mg Twice Daily (BID) | 0.224 | 95% Confidence Interval 0.179 to 0.282 | Relapses Per Year | |
| Annualized Relapse Rate | BG00012 240 mg 3 Times Daily (TID) | 0.198 | 95% Confidence Interval 0.156 to 0.252 | Relapses Per Year | |
| Annualized Relapse Rate | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 0.286 | 95% Confidence Interval 0.232 to 0.353 | Relapses Per Year | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | Placebo | 17.4 | 95% Confidence Interval 13.5 to 22.4 | Number of lesions | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | BG00012 240 mg Twice Daily (BID) | 5.1 | 95% Confidence Interval 3.9 to 6.6 | Number of lesions | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | BG00012 240 mg 3 Times Daily (TID) | 4.7 | 95% Confidence Interval 3.6 to 6.2 | Number of lesions | |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 8.0 | 95% Confidence Interval 6.3 to 10.2 | Number of lesions | |
| Number of New T1 Hypointense Lesions | Placebo | 7.0 | 95% Confidence Interval 5.3 to 9.2 | Number of lesions | |
| Number of New T1 Hypointense Lesions | BG00012 240 mg Twice Daily (BID) | 3.0 | 95% Confidence Interval 2.3 to 4.0 | Number of lesions |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 363 | |
| Overall Study | STARTED | BG00012 240 mg Twice Daily (BID) | 359 | |
| Overall Study | STARTED | BG00012 240 mg 3 Times Daily (TID) | 345 | |
| Overall Study | STARTED | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 350 | |
| Overall Study | COMPLETED | Placebo | 278 | |
| Overall Study | COMPLETED | BG00012 240 mg Twice Daily (BID) | 284 | |
| Overall Study | COMPLETED | BG00012 240 mg 3 Times Daily (TID) | 273 | |
| Overall Study | COMPLETED | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 292 | |
| Overall Study | NOT COMPLETED | Placebo | 85 | |
| Overall Study | NOT COMPLETED | BG00012 240 mg Twice Daily (BID) | 75 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events785
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 | 58 | 363 | |
| other | NASOPHARYNGITIS | Infections and infestations | BG00012 240 mg Twice Daily (BID) | 62 | 359 | |
| other | NASOPHARYNGITIS | Infections and infestations | BG00012 240 mg 3 Times Daily (TID) | 63 | 344 | |
| other | NASOPHARYNGITIS | Infections and infestations | Total BG00012 | 125 | 703 | |
| other | NASOPHARYNGITIS | Infections and infestations | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 51 | 351 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 42 | 363 | |
| other | URINARY TRACT INFECTION | Infections and infestations | BG00012 240 mg Twice Daily (BID) | 51 | 359 | |
| other | URINARY TRACT INFECTION | Infections and infestations | BG00012 240 mg 3 Times Daily (TID) | 40 | 344 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Total BG00012 | 91 | 703 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 46 | 351 |
1 to 10 of 785Source ClinicalTrials.gov
See all 785 adverse eventsAdverse event totals15
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, all-cause mortality | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | ||
| Total, other adverse events | Placebo | 332 | 363 |
| Total, other adverse events | BG00012 240 mg Twice Daily (BID) | 336 | 359 |
| Total, other adverse events | BG00012 240 mg 3 Times Daily (TID) | 316 | 344 |
| Total, other adverse events | Total BG00012 | 652 | 703 |
| Total, other adverse events | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | 303 | 351 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers10
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/NCT00451451
GET https://conductscience.org/api/trials/v1/NCT00451451/events?page=2