Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis
1 other identifier
interventional
97
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 14, 2016
CompletedJanuary 14, 2016
December 1, 2015
4.2 years
March 24, 2011
December 10, 2015
December 10, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 1 up to approximately 50 months
Secondary Outcomes (2)
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
Study Arms (1)
natalizumab
EXPERIMENTAL300 mg intravenous (IV) infusions of natalizumab every 4 weeks until product is approved in Japan or development is discontinued in Japan, whichever comes first.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Treatment with any of the following medications between last dose of study treatment in Study 101MS203 (NCT01440101) and the start of this study: intravenous immunoglobulin (IVIg), plasmapheresis, cytapheresis, immunosuppressant medications (e.g., mitoxantrone, azathioprine, cyclophosphamide, methotrexate, cyclosporine, FTY720), immunomodulatory medications (including IFNβ and glatiramer acetate \[GA\]) total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, any murine protein, any other therapeutic monoclonal antibody, or any 4-aminopyridine or related products.
- Miscellaneous
- For female subjects, unless postmenopausal for at least 1 year or surgically sterile (does not include tubal ligation), unwillingness to practice effective contraception, as defined by the Investigator, during the study. Women considering becoming pregnant while on study are to be excluded.
- Female subjects who are currently pregnant or breast feeding, including subjects whose pregnancy test is positive at Week 0.
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- Subjects with any other condition, clinical finding, or reason that in the opinion of the Investigator and/or the Sponsor makes the subject unsuitable for enrollment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (22)
Research Site
Chiba, Chiba, 260-8677, Japan
Research Site
Fukuoka, Fukuoka, 812-8582, Japan
Research Site
Hiroshima, Hiroshima, 734-8551, Japan
Research Site
Sapporo, Hokkaido, 060-8648, Japan
Research Site
Sapporo, Hokkaido, 063-0005, Japan
Research Site
Tsukuba, Ibaraki, 305-8576, Japan
Research Site
Morioka, Iwate, 020-8505, Japan
Research Site
Yokohama, Kanagawa, 232-0024, Japan
Research Site
Kyoto, Kyoto, 604-8453, Japan
Research Site
Kyoto, Kyoto, 606-8507, Japan
Research Site
Kyoto, Kyoto, 616-8255, Japan
Research Site
Sendai, Miyagi, 980-8574, Japan
Research Site
Niigata, Niigata, 951-8520, Japan
Research Site
Osaka, Osaka, 556-0016, Japan
Research Site
Suita, Osaka, 565-0871, Japan
Research Site
Kawagoe, Saitama, 350-8550, Japan
Research Site
Tokorozawa, Saitama, 359-8513, Japan
Research Site
Bunkyo-ku, Tokyo, 113-8431, Japan
Research Site
Bunkyo-ku, Tokyo, 113-8519, Japan
Research Site
Kodaira, Tokyo, 187-8551, Japan
Research Site
Ōta-ku, Tokyo, 145-0065, Japan
Research Site
Ube, Yamaguchi, 755-8505, Japan
Related Publications (1)
Saida T, Kira JI, Kishida S, Yamamura T, Ohtsuka N, Ling Y, Torii S, Lucas N, Kuesters G, Steiner D, Tibung JT; Natalizumab Trial Principal Investigators. Safety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial. Neurol Ther. 2017 Jun;6(1):39-55. doi: 10.1007/s40120-016-0059-z. Epub 2016 Dec 5.
PMID: 27921221DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
August 12, 2011
Study Start
October 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 14, 2016
Results First Posted
January 14, 2016
Record last verified: 2015-12