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Also known as BG00012, BG00012 (dimethyl fumarate)
BG00012 Dose 1 · 5 trials · 4 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| BG00012 240 mg Twice Daily (BID) | EXPERIMENTAL | Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) |
| BG00012 240 mg 3 Times Daily (TID) | EXPERIMENTAL | Participants received two 120 mg BG00012 capsules orally three times daily (TID) |
| Placebo | PLACEBO_COMPARATOR | Participants received two placebo capsules orally three times daily (TID) |
| Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | ACTIVE_COMPARATOR | Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD) |
| 1 | ACTIVE_COMPARATOR | BG00012 480 mg/day |
| 2 | ACTIVE_COMPARATOR | BG00012 720 mg/day |
| 3 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BG00012 | DRUG | - |
| Placebo | DRUG | - |
| Glatiramer Acetate | DRUG | - |
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: * Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4 * Must have a baseline EDSS between...
BG00012 Dose 1 is a small molecule drug candidate developed by Biogen Inc. (ticker BIIB) for neurology indications. It has been studied in relapsing remitting multiple sclerosis and rheumatoid arthritis. The program includes completed Phase 1, Phase 2, and Phase 3 clinical trials, with a total enrollment of 2,699 participants across those studies.
BG00012 Dose 1 has been studied for relapsing remitting multiple sclerosis and rheumatoid arthritis. Clinical trials evaluated it in patients with active rheumatoid arthritis alongside methotrexate and in relapsing remitting multiple sclerosis. It is an investigational therapy and is not described as approved for any indication.
BG00012 Dose 1 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen sponsored the clinical trials of the drug in relapsing remitting multiple sclerosis and rheumatoid arthritis, including Phase 1, Phase 2, and Phase 3 studies.
BG00012 Dose 1 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The program is listed at Phase 2 overall, and all three completed trials have finished. It is an investigational drug and is not described as FDA approved for any indication.
BG00012 Dose 1 has been evaluated in completed trials including NCT00837785, a Phase 1 pharmacokinetic study in relapsing remitting multiple sclerosis; NCT00810836, a Phase 2 study with methotrexate in active rheumatoid arthritis; and Phase 3 trials NCT00451451 and NCT00420212 in relapsing remitting multiple sclerosis.
Yes, BG00012 Dose 1 is also known as BG00012 and BG00012 (dimethyl fumarate). These names refer to the same small molecule drug candidate developed by Biogen Inc. for relapsing remitting multiple sclerosis and rheumatoid arthritis.