Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00420212
First received: January 8, 2007
Last updated: May 5, 2014
Last verified: May 2014

January 8, 2007
May 5, 2014
January 2007
February 2011   (final data collection date for primary outcome measure)
Proportion of Subjects Relapsed [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 neurolgic 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.
To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years.
Complete list of historical versions of study NCT00420212 on ClinicalTrials.gov Archive Site
  • Number of New or Newly Enlarging T2 Hyperintense Lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume
  • Number of Gadolinium-enhancing T1-weighted Lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.
  • Number of Subjects With Gadolinium (Gd)-Enhancing Lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"
  • Annualized Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
  • Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS 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 a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks 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.
There are multiple secondary outcomes.
Not Provided
Not Provided
 
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. 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 the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Drug: BG00012
    Other Names:
    • dimethyl fumarate
    • Tecfidera®
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Participants received two placebo capsules orally three times daily (TID)
    Intervention: Drug: Placebo
  • 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)
    Intervention: Drug: BG00012
  • Experimental: BG00012 240 mg 3 Times Daily (TID)
    Participants received two 120 mg BG00012 capsules orally three times daily (TID)
    Intervention: Drug: BG00012

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1234
February 2011
February 2011   (final data collection date for primary outcome measure)

Key Inclusion 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:
  • Must have a 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:

  • Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
  • Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
  • Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States,   Virgin Islands (U.S.),   Austria,   Belgium,   Bosnia and Herzegovina,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Greece,   Guatemala,   India,   Israel,   Italy,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Moldova, Republic of,   Netherlands,   New Zealand,   Poland,   Romania,   Serbia,   Slovakia,   South Africa,   Switzerland,   Ukraine,   United Kingdom
 
NCT00420212
109MS301
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP