Status:
COMPLETED
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 particip...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01156311
Start Date
June 1 2010
End Date
March 1 2012
Last Update
March 21 2017
Active Locations (16)
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1
Research Site
Gilbert, Arizona, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Danbury, Connecticut, United States
4
Research Site
Atlanta, Georgia, United States