Phase 2
Completed N=108
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
Source: ClinicalTrials.gov NCT01156311 ↗Enrolled (actual)
108
Serious AEs
1.4%
Results posted
Jun 2015
Primary outcomePrimary: Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) — 95; 100; 72; 70 percentage of participants
Summary
The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) |
95; 100; 72; 70; 14; 15 | — |
| PRIMARY Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy |
9; 2; 2; 2; 32; 6 | — |
| PRIMARY Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy |
47; 47; 53; 53; 5; 2 | — |
| PRIMARY Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy |
75; 64; 7; 9; 5; 15 | — |
Eligibility Criteria
Key Inclusion Criteria
- Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time.
- Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.
- Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.
Key Exclusion Criteria
- Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005).
- Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
- Pregnant or nursing women.
- Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01156311). 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.