Trial · NCT00835770
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
NCT00835770, Phase 3, Completed, Biogen; results first posted 2020-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS). Trials, record NCT00835770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
- NCT number
- NCT00835770
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,736 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- dimethyl fumarate, Placebo
- First posted
- 2009-02-04
- Last updated
- 2020-12-31
- Other registries' IDs
- eudract:2008-004753-14
- Results first posted
- 2020-12-31
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 561 | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Secondary | Percentage of Participants Who Had Relapses | Day 1 up to Week 384 | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours. |
| Secondary | Annualized Relapse Rate (ARR) | Day 1 up to Week 384 | The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period. |
| Secondary | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline, Week 384 | EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks. |
| Secondary | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Secondary | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Secondary | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Secondary | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Secondary | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
| Secondary | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 561 | Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Had Relapses | Day 1 up to Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | percentage of participants | NUMBER |
| SECONDARY | Annualized Relapse Rate (ARR) | Day 1 up to Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | relapses per participant-years | NUMBER |
| SECONDARY | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | score on a scale | MEAN |
| SECONDARY | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | millimeter cube (mm^3) | MEAN |
| SECONDARY | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | mm^3 | MEAN |
| SECONDARY | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | mm^3 | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group512
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | BG00012 240 mg BID | 824 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | BG00012 240 mg TID | 814 | Participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg BID (Prior BG00012 240 mg BID) | 40 | percentage of participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg TID (Prior BG00012 240 mg TID) | 41 | percentage of participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg BID (Prior BG00012 Matched Placebo) | 34 | percentage of participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg TID (Prior BG00012 Matched Placebo) | 36 | percentage of participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | 31 | percentage of participants | ||
| Percentage of Participants Who Had Relapses | BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | 31 | percentage of participants | ||
| Annualized Relapse Rate (ARR) | BG00012 240 mg BID (Prior BG00012 240 mg BID) | 0.159 | relapses per participant-years | ||
| Annualized Relapse Rate (ARR) | BG00012 240 mg TID (Prior BG00012 240 mg TID) | 0.179 | relapses per participant-years |
1 to 10 of 512Source ClinicalTrials.gov
See all 512 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BG00012 240 mg BID | 868 | |
| Overall Study | STARTED | BG00012 240 mg TID | 868 | |
| Overall Study | COMPLETED | BG00012 240 mg BID | 384 | |
| Overall Study | COMPLETED | BG00012 240 mg TID | 375 | |
| Overall Study | NOT COMPLETED | BG00012 240 mg BID | 484 | |
| Overall Study | NOT COMPLETED | BG00012 240 mg TID | 493 |
Source ClinicalTrials.gov
Adverse events812
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 | Lymphopenia | Blood and lymphatic system disorders | BG00012 240 mg BID | 52 | 868 | |
| other | Lymphopenia | Blood and lymphatic system disorders | BG00012 240 mg TID | 42 | 868 | |
| other | Abdominal pain | Gastrointestinal disorders | BG00012 240 mg BID | 50 | 868 | |
| other | Abdominal pain | Gastrointestinal disorders | BG00012 240 mg TID | 55 | 868 | |
| other | Abdominal pain upper | Gastrointestinal disorders | BG00012 240 mg BID | 69 | 868 | |
| other | Abdominal pain upper | Gastrointestinal disorders | BG00012 240 mg TID | 76 | 868 | |
| other | Diarrhoea | Gastrointestinal disorders | BG00012 240 mg BID | 111 | 868 | |
| other | Diarrhoea | Gastrointestinal disorders | BG00012 240 mg TID | 118 | 868 | |
| other | Nausea | Gastrointestinal disorders | BG00012 240 mg BID | 56 | 868 | |
| other | Nausea | Gastrointestinal disorders | BG00012 240 mg TID | 61 | 868 |
1 to 10 of 812Source ClinicalTrials.gov
See all 812 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BG00012 240 mg BID | 5 | 868 |
| Total, all-cause mortality | BG00012 240 mg TID | 6 | 868 |
| Total, other adverse events | BG00012 240 mg BID | 779 | 868 |
| Total, other adverse events | BG00012 240 mg TID | 767 | 868 |
| Total, serious adverse events | BG00012 240 mg BID | 279 | 868 |
| Total, serious adverse events | BG00012 240 mg TID | 272 | 868 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BG00012 240 mg BID vs BG00012 240 mg TID: Number of Participants With Treatment-Emergent Adverse Events (AEs) | Trial comparisons |
| BG00012 240 mg BID vs BG00012 240 mg TID: deaths from any cause | Trial comparisons |
| BG00012 240 mg BID vs BG00012 240 mg TID: serious adverse events | Trial comparisons |
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/NCT00835770
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