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Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (CONFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00451451
Recruitment Status : Completed
First Posted : March 23, 2007
Results First Posted : June 2, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: BG00012 Drug: Placebo Drug: Glatiramer Acetate Phase 3

Detailed Description:
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Start Date : June 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BG00012 240 mg Twice Daily (BID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
 Drug: BG00012
Other Names:
  • dimethyl fumarate
  • Tecfidera®

Drug: Placebo
Experimental: BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
 Drug: BG00012
Other Names:
  • dimethyl fumarate
  • Tecfidera®
Placebo Comparator: Placebo
Participants received two placebo capsules orally three times daily (TID)
 Drug: Placebo
Active Comparator: Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
 Drug: Glatiramer Acetate


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Relapse Rate [ Time Frame: 2 years ]

    A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.

    The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.



Secondary Outcome Measures :
  1. Number of New or Newly Enlarging T2 Hyperintense Lesions [ Time Frame: 2 years ]
    The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.

  2. Number of New T1 Hypointense Lesions [ Time Frame: 2 years ]
    The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.

  3. Proportion of Subjects Relapsed [ Time Frame: 2 years ]
    A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.

  4. Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ]
    EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution


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

Contacts and Locations
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Information from the National Library of Medicine

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): NCT00451451


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00451451    
Other Study ID Numbers: 109MS302
First Posted: March 23, 2007    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Biogen:
relapsing
multiple sclerosis
oral
remitting
Additional relevant MeSH terms:
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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
 Glatiramer Acetate
Dimethyl Fumarate
(T,G)-A-L
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antirheumatic Agents