Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG00012 · 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 is an investigational small molecule being studied for the treatment of relapsing-remitting multiple sclerosis and active rheumatoid arthritis. It is developed by Biogen Inc. (NASDAQ: BIIB) and is currently in clinical development, with completed trials in both indications.
BG00012 is a small molecule developed by Biogen Inc. (NASDAQ: BIIB) for neurological and inflammatory conditions. Its specific molecular target has not been disclosed in available clinical trial information, and it is being evaluated for its efficacy and safety in relapsing-remitting multiple sclerosis and rheumatoid arthritis.
BG00012 is being developed by Biogen Inc., a biotechnology company traded on NASDAQ under the ticker BIIB. Biogen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsing-remitting multiple sclerosis and rheumatoid arthritis.
BG00012 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The most advanced completed studies are Phase 3 trials in relapsing-remitting multiple sclerosis, and a Phase 2 trial in rheumatoid arthritis. BG00012 is investigational and not yet approved by regulatory authorities.
BG00012 has completed three clinical trials: NCT00420212, a Phase 3 study in relapsing-remitting multiple sclerosis with 1,234 participants; NCT00451451, a Phase 3 study with active reference in relapsing-remitting multiple sclerosis with 1,417 participants; and NCT00810836, a Phase 2 study with methotrexate in active rheumatoid arthritis with 153 participants.
BG00012 is an investigational drug developed by Biogen Inc. (NASDAQ: BIIB) for relapsing-remitting multiple sclerosis and rheumatoid arthritis. It has completed Phase 3 trials in multiple sclerosis and Phase 2 trials in rheumatoid arthritis, but its chemical identity and relationship to other compounds have not been disclosed in the available clinical trial data.