A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis
Overview
- Phase
- Phase 2
- Intervention
- natalizumab
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Sponsor
- Biogen
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
This is a multicenter, long-term, open-label, extension study in participants who have successfully completed Study 101MS203 (NCT01440101).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law.
- •Subjects who participated in and completed all protocol-related evaluations through Week 24 of Study 101MS203 (NCT01440101).
- •Subjects participating in study 101MS204 (NCT01416155) participated either in the open label pharmacokinetics-pharmacodynamics study or placebo-controlled study of natalizumab 300 mg q4wks (parts A and B of study 101MS203, respectively).
- •Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.
- •Must be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta \[IFNβ\] and long-term systemic corticosteroids) for the duration of the study.
- •Key Exclusion Criteria Medical History
- •Any significant change in medical history since Study 101MS203 (NCT01440101), including laboratory tests, or current clinically important condition that in the opinion of the Investigator would have excluded the subject's participation in the previous study. The Investigator must re-review the subject's medical fitness for participation and consider diseases that would preclude treatment.
- •Subjects from Study 101MS203 (NCT01440101) who discontinued study treatment due to an adverse event.
- •Subjects who are determined to be persistently positive for anti-BG0002 antibodies based on prior testing.
- •Treatment History
Exclusion Criteria
- Not provided
Arms & Interventions
natalizumab
300 mg intravenous (IV) infusions of natalizumab every 4 weeks until product is approved in Japan or development is discontinued in Japan, whichever comes first.
Intervention: natalizumab
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
Time Frame: Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months
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.
Number of Participants With Serum Antibodies to Natalizumab
Time Frame: Day 1 up to approximately 50 months
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.
Secondary Outcomes
- Adjusted Annualized Relapse Rate(Day 1 up to approximately 50 months)
- Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192(Day 1 up to Week 192)