Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis

NCT ID: NCT01416155

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-12-31

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).

Conditions

Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

natalizumab

Intervention Type: DRUG

Interventions

natalizumab

Intervention Type: DRUG

Other Intervention Names

Tysabri; BG00002

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Chiba, Chiba, Japan

Research Site

Fukuoka, Fukuoka, Japan

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

Research Site

Kyoto, Kyoto, Japan

Research Site

Sendai, Miyagi, Japan

Research Site

Niigata, Niigata, Japan

Research Site

Osaka, Osaka, Japan

Research Site

Suita, Osaka, Japan

Research Site

Kawagoe, Saitama, Japan

Research Site

Tokorozawa, Saitama, Japan

Research Site

Bunkyo-ku, Tokyo, Japan

Research Site

Bunkyo-ku, Tokyo, Japan

Research Site

Kodaira, Tokyo, Japan

Research Site

Ōta-ku, Tokyo, Japan

Research Site

Ube, Yamaguchi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 27921221 (View on PubMed)

Other Identifiers

101MS204

Identifier Type: -

Identifier Source: org_study_id