A Phase 3 interventional study of BG00012 and Placebo in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 195 sites in 28 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.
Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.
615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's enrollment of 1,417 is above the median of 72 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Drug: BG00012 · Drug: Placebo
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Drug: BG00012
Participants received two placebo capsules orally three times daily (TID)
Drug: Placebo
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Drug: Glatiramer Acetate
Also known as: dimethyl fumarate, Tecfidera®
Annualized Relapse Rate
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.
Time frame: 2 years
Number of New or Newly Enlarging T2 Hyperintense Lesions
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.
Time frame: 2 years
Number of New T1 Hypointense Lesions
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.
Time frame: 2 years
Proportion of Subjects Relapsed
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.
Time frame: 2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
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
Time frame: 2 years
Subjects were randomized at 205 investigational sites in 28 countries.
| Milestone | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Started | 363 | 359 | 345 | 350 |
| Completed | 278 | 284 | 273 | 292 |
| Not completed | 85 | 75 | 72 | 58 |
| Withdrew: Adverse event | 11 | 21 | 26 | 10 |
| Withdrew: Lost to follow-up | 11 | 9 | 8 | 11 |
| Withdrew: Consent withdrawn | 14 | 9 | 17 | 17 |
| Withdrew: Investigator decision | 6 | 2 | 1 | 2 |
| Withdrew: Subject non-compliance | 8 | 4 | 3 | 3 |
| Withdrew: Death | 1 | 0 | 0 | 1 |
| Withdrew: Other reasons for not completing study | 34 | 30 | 17 | 14 |
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.
| Relapses Per Year | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Annualized Relapse Rate | 0.401 (0.329 to 0.488) | 0.224 (0.179 to 0.282) | 0.198 (0.156 to 0.252) | 0.286 (0.232 to 0.353) |
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.
| Number of lesions | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Number of New or Newly Enlarging T2 Hyperintense Lesions | 17.4 (13.5 to 22.4) | 5.1 (3.9 to 6.6) | 4.7 (3.6 to 6.2) | 8.0 (6.3 to 10.2) |
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.
| Number of lesions | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Number of New T1 Hypointense Lesions | 7.0 (5.3 to 9.2) | 3.0 (2.3 to 4.0) | 2.4 (1.8 to 3.2) | 4.1 (3.2 to 5.3) |
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.
| Proportion of subjects,confirmed relapse | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Proportion of Subjects Relapsed | 0.410 | 0.291 | 0.241 | 0.321 |
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
| Proportion of Participants | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|
| Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | 0.169 | 0.128 | 0.130 | 0.156 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 79/363 (21.8%) | 332/363 (91.5%) |
| BG00012 240 mg Twice Daily (BID) | — | 61/359 (17%) | 336/359 (93.6%) |
| BG00012 240 mg 3 Times Daily (TID) | — | 54/344 (15.7%) | 316/344 (91.9%) |
| Total BG00012 | — | 115/703 (16.4%) | 652/703 (92.7%) |
| Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | — | 60/351 (17.1%) | 303/351 (86.3%) |
| Event | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Total BG00012 | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|---|
| MULTIPLE SCLEROSIS RELAPSENervous system disorders | 51/363 | 39/359 | 30/344 | 69/703 | 36/351 |
| GASTROENTERITISInfections and infestations | 0/363 | 2/359 | 2/344 | 4/703 | 0/351 |
| MUSCLE STRAINInjury, poisoning and procedural complications | 0/363 | 0/359 | 2/344 | 2/703 | 0/351 |
| PNEUMONIAInfections and infestations | 1/363 | 0/359 | 0/344 | 0/703 | 2/351 |
| ANAPHYLACTIC REACTIONImmune system disorders | 0/363 | 0/359 | 0/344 | 0/703 | 2/351 |
| DEPRESSIONPsychiatric disorders | 0/363 | 0/359 | 1/344 | 1/703 | 2/351 |
| CELLULITISInfections and infestations | 0/363 | 2/359 | 1/344 | 3/703 | 0/351 |
| ABDOMINAL PAINGastrointestinal disorders | 0/363 | 2/359 | 0/344 | 2/703 | 0/351 |
| BACK PAINMusculoskeletal and connective tissue disorders | 0/363 | 2/359 | 0/344 | 2/703 | 0/351 |
| CONVULSIONNervous system disorders | 2/363 | 0/359 | 0/344 | 0/703 | 0/351 |
| Event | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Total BG00012 | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) |
|---|---|---|---|---|---|
| MULTIPLE SCLEROSIS RELAPSENervous system disorders | 147/363 | 104/359 | 81/344 | 185/703 | 115/351 |
| FLUSHINGVascular disorders | 13/363 | 110/359 | 83/344 | 193/703 | 6/351 |
| NASOPHARYNGITISInfections and infestations | 58/363 | 62/359 | 63/344 | 125/703 | 51/351 |
| NAUSEAGastrointestinal disorders | 29/363 | 40/359 | 51/344 | 91/703 | 15/351 |
| DIARRHEAGastrointestinal disorders | 28/363 | 45/359 | 50/344 | 95/703 | 14/351 |
| HEADACHENervous system disorders | 49/363 | 52/359 | 46/344 | 98/703 | 46/351 |
| URINARY TRACT INFECTIONInfections and infestations | 42/363 | 51/359 | 40/344 | 91/703 | 46/351 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 34/363 | 36/359 | 47/344 | 83/703 | 27/351 |
| BACK PAINMusculoskeletal and connective tissue disorders | 33/363 | 34/359 | 36/344 | 70/703 | 32/351 |
| FATIGUEGeneral disorders | 33/363 | 37/359 | 33/344 | 70/703 | 30/351 |
| Age, Continuous(Years) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 36.9 ± 9.24 | 37.8 ± 9.35 | 37.8 ± 9.39 | 36.7 ± 9.06 | 37.3 ± 9.26 |
| Sex: Female, Male(Participants) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Female | 251 | 245 | 250 | 247 | 993 |
| Male | 112 | 114 | 95 | 103 | 424 |
| Mean Expanded Disability Status Scale (EDSS) score(units on a scale) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 2.59 ± 1.170 | 2.56 ± 1.202 | 2.52 ± 1.185 | 2.57 ± 1.223 | 2.56 ± 1.194 |
| Mean number of relapses within the previous 3 years(Number of relapses) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 2.5 ± 1.46 | 2.4 ± 1.27 | 2.6 ± 1.50 | 2.4 ± 1.32 | 2.5 ± 1.39 |
| Mean number of relapses within the past 12 months(Number of relapses) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 1.4 ± 0.80 | 1.3 ± 0.63 | 1.4 ± 0.72 | 1.4 ± 0.64 | 1.4 ± 0.70 |
| Time since first multiple sclerosis (MS) diagnosis(years) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 4.8 ± 5.01 | 4.9 ± 5.11 | 4.6 ± 5.23 | 4.4 ± 4.70 | 4.7 ± 5.01 |
| Mean number of Gadolinium(Gd)-enhancing T1-weighted lesions(Number of Gd enhancing lesions) | Placebo | BG00012 240 mg Twice Daily (BID) | BG00012 240 mg 3 Times Daily (TID) | Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | Total |
|---|---|---|---|---|---|
| Mean | 2.7 ± 7.71 | 2.7 ± 6.22 | 1.9 ± 5.02 | 2.4 ± 6.81 | 2.4 ± 6.51 |
Showing the first 100 of 195 sites across 28 countries.
The record gives a start of Jun 2007, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 2 years 10 months after primary completion. A results delay was requested in Nov 2012.
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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dimethyl Fumarate
Multiple Sclerosis, Relapsing-Remitting →