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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00451451
Registration number
NCT00451451
Ethics application status
Date submitted
21/03/2007
Date registered
23/03/2007
Date last updated
26/01/2015
Titles & IDs
Public title
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
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Scientific 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
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Secondary ID [1]
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109MS302
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Universal Trial Number (UTN)
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Trial acronym
CONFIRM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BG00012
Treatment: Drugs - Placebo
Treatment: Drugs - Glatiramer Acetate
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)
Experimental: BG00012 240 mg 3 Times Daily (TID) - Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Placebo Comparator: Placebo - Participants received two placebo capsules orally three times daily (TID)
Active Comparator: Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) - Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Treatment: Drugs: BG00012
Treatment: Drugs: Placebo
Treatment: Drugs: Glatiramer Acetate
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualized Relapse Rate
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Number of New or Newly Enlarging T2 Hyperintense Lesions
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Number of New T1 Hypointense Lesions
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Assessment method [2]
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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.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Proportion of Subjects Relapsed
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
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Assessment method [4]
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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
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Timepoint [4]
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2 years
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Eligibility
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:
Key
- 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
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Minimum age
18
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
1417
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Novi Sad
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Slovakia
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Kosice
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Martin
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Bilbao
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Cordoba
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Gandia
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Madrid
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Malaga
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Sevilla
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Lviv
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Odessa
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Ukraine
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Ukraine
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Simferopol
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Ukraine
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Zaporozhye
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Funding & Sponsors
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Biogen
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00451451
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Biogen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00451451
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