The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
administered orally
Research Site
Loma Linda, California, United States
Research Site
Ghent, Belgium
Research Site
Sofia, Bulgaria
Research Site
Hradec Králové, Czechia
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: Baseline to Week 96
Number of Participants Discontinuing Treatment Due to an Adverse Event
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.
Time frame: Baseline to Week 96
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24
T2 hyperintense lesions were measured by MRI brain scans.
Time frame: Week 16 to Week 24
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72
T2 hyperintense lesions were measured by MRI brain scans.
Time frame: Week 64 to Week 72
Average Annualized Relapse Rate (ARR)
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively.
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Research Site
Munich, Bavaria, Germany
Research Site
Göttingen, Lower Saxony, Germany
Research Site
Kuwait City, Kuwait
Research Site
Riga, Latvia
Research Site
Beirut, Lebanon
Research Site
Gdansk, Poland
...and 2 more locations
Time frame: Baseline to Week 96
Percentage of Participants Experiencing One or More Relapses
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
Time frame: Baseline to Week 96
Change From Baseline in the Degree of Disability
The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Time frame: Baseline to Week 96
Number of Participants Experiencing Disability Progression
Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
Time frame: Baseline to Week 96