Clinical trial NCT01156311: BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
Official title: An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Keywords: BG00012
MS
RRMS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 participants with relapsing-remitting multiple sclerosis (RRMS).


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.

Primary outcomes:
measure: Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
timeFrame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
measure: Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
timeFrame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
measure: Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
timeFrame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
measure: Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
timeFrame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Secondary outcomes:
Other outcomes:
measure: Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)
timeFrame: from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)
measure: Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average
timeFrame: Week -8 through Week 24
measure: Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average
timeFrame: Week -4 through Week 24
measure: Number of New or Newly Enlarging T2 Lesions
timeFrame: Week -8 to Week 24
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Golden Valley
country: United States
facility: Research Site
state: Minnesota
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Cordova
country: United States
facility: Research Site
state: Tennessee
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020.