The primary objective of the study is to further evaluate the long-term safety and tolerability profiles of BG00002 (natalizumab) in Japanese participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to further evaluate the long-term efficacy profile of BG00002 in Japanese participants with RRMS.
This is a multicenter, long-term, open-label, extension study in participants who have successfully completed Study 101MS203 (NCT01440101).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Research Site
Chiba, Chiba, Japan
Research Site
Fukuoka, Fukuoka, Japan
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.
Time frame: Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months
Number of Participants With Serum Antibodies to Natalizumab
Negative is defined as negative for antibodies at all post-baseline results. Transient positivity is defined as only 1 positive result. Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.
Time frame: Day 1 up to approximately 50 months
Adjusted Annualized Relapse Rate
Clinical relapses are defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. The annualized relapse rate is calculated overall as the total number of relapses experienced in the study divided by the number of days followed in the study, and the ratio multiplied by 365. Obtained from a Poisson regression model, adjusted for the baseline relapse rate from study 101MS203 (NCT01440101).
Time frame: Day 1 up to approximately 50 months
Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192
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Research Site
Hiroshima, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
...and 12 more locations
The 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: Day 1 up to Week 192