BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis (EXPLORE)
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ClinicalTrials.gov Identifier: NCT01156311 |
Recruitment Status
:
Completed
First Posted
: July 2, 2010
Results First Posted
: June 9, 2015
Last Update Posted
: March 21, 2017
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Condition or disease | Intervention/treatment | Phase |
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Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis | Drug: dimethyl fumarate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | June 2010 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
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Experimental: Glatiramer acetate (GA) and dimethyl fumarate
Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
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Drug: dimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Other Names:
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Experimental: Interferon beta (IFNβ) and dimethyl fumarate
Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
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Drug: dimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Other Names:
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- Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) [ Time Frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days). ]An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.
- Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy [ Time Frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days ]Percentage of participants with potentially clinically significant hematology laboratory abnormalities.
- Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy [ Time Frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days ]Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.
- Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy [ Time Frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days ]Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.
- Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) [ Time Frame: from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0) ]Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.
- Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average [ Time Frame: Week -8 through Week 24 ]The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging [MRI] scans).
- Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average [ Time Frame: Week -4 through Week 24 ]The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).
- Number of New or Newly Enlarging T2 Lesions [ Time Frame: Week -8 to Week 24 ]The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156311
United States, Arizona | |
Research Site | |
Gilbert, Arizona, United States | |
Research Site | |
Phoenix, Arizona, United States | |
United States, Connecticut | |
Research Site | |
Danbury, Connecticut, United States | |
United States, Georgia | |
Research Site | |
Atlanta, Georgia, United States | |
United States, Indiana | |
Research Site | |
Fort Wayne, Indiana, United States | |
United States, Maryland | |
Research Site | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Research Site | |
Boston, Massachusetts, United States | |
United States, Minnesota | |
Research Site | |
Golden Valley, Minnesota, United States | |
United States, New Jersey | |
Research Site | |
Teaneck, New Jersey, United States | |
United States, New York | |
Research Site | |
Patchogue, New York, United States | |
United States, Ohio | |
Research Site | |
Cleveland, Ohio, United States | |
Research Site | |
Dayton, Ohio, United States | |
United States, Oregon | |
Research Site | |
Portland, Oregon, United States | |
United States, Tennessee | |
Research Site | |
Cordova, Tennessee, United States | |
Research Site | |
Franklin, Tennessee, United States | |
United States, Wisconsin | |
Research Site | |
Milwaukee, Wisconsin, United States |
Study Director: | Medical Director | Biogen |
Publications:
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01156311 History of Changes |
Other Study ID Numbers: |
109MS201 |
First Posted: | July 2, 2010 Key Record Dates |
Results First Posted: | June 9, 2015 |
Last Update Posted: | March 21, 2017 |
Last Verified: | February 2017 |
Keywords provided by Biogen:
BG00012 MS RRMS |
Additional relevant MeSH terms:
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons |
Glatiramer Acetate Dimethyl Fumarate Antineoplastic Agents Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Antirheumatic Agents Dermatologic Agents |