Phase 3
Completed N=1,417
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00451451 ↗Enrolled (actual)
1,417
Serious AEs
17.4%
Results posted
Jun 2014
Primary outcomePrimary: Annualized Relapse Rate — 0.401; 0.224; 0.198; 0.286 Relapses Per Year
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate |
0.401; 0.224; 0.198; 0.286 | — |
| SECONDARY Number of New or Newly Enlarging T2 Hyperintense Lesions |
17.4; 5.1; 4.7; 8.0 | — |
| SECONDARY Number of New T1 Hypointense Lesions |
7.0; 3.0; 2.4; 4.1 | — |
| SECONDARY Proportion of Subjects Relapsed |
0.410; 0.291; 0.241; 0.321 | — |
| SECONDARY Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) |
0.169; 0.128; 0.130; 0.156 | — |
Eligibility Criteria
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 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00451451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.