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Extension Study to Evaluate Safety and Efficacy of BG00002 (Natalizumab) in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (JapanExtension)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Innovation House
Biogen Idec Japan Ltd.
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01416155
First received: March 24, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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). Secondary objective of this study is to further evaluate the long-term efficacy profile of BG00002 in Japanese participants with RRMS.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Drug: BG00002 (natalizumab)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Day 1 up to approximately 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of serum antibodies to natalizumab [ Time Frame: Day 1 up to approximately 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annualized Relapse Rates [ Time Frame: Day 1 up to approximately 3 years ] [ Designated as safety issue: No ]
    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.

  • Change from study start to various study timeframes in the Assessment of Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 up to approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: October 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00002 300 mg
300mg IV infusions of BG00002 every 4 weeks until product is approved in Japan or development is discontinued in Japan, whichever comes first.
Drug: BG00002 (natalizumab)
Recombinant humanized anti-alpha4 integrin antibody supplied as a liquid to be infused.
Other Name: Tysabri

Detailed Description:

This will be a multicenter, long-term, open-label, extension study in participants who have successfully completed Study 101MS203.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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 of childbearing potential must practice effective 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

• 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 monocloncal 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416155

Locations
Japan
Research Site
Chiba,, Japan
Research Site
Fukuoka,, Japan
Research Site
Hiroshima,, Japan
Research Site
Kawagoe,, Japan
Research Site
Kodaira,, Japan
Research Site
Kyoto,, Japan
Research Site
Morioka,, Japan
Research Site
Niigata,, Japan
Research Site
Osaka,, Japan
Research Site
Sapporo,, Japan
Research Site
Sendai,, Japan
Research Site
Suita,, Japan
Research Site
Tokorozawa,, Japan
Research Site
Tokyo,, Japan
Research Site
Tsukuba,, Japan
Research Site
Ube,, Japan
Research Site
Yokohama,, Japan
Sponsors and Collaborators
Biogen Idec
Innovation House
Biogen Idec Japan Ltd.
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01416155     History of Changes
Other Study ID Numbers: 101MS204
Study First Received: March 24, 2011
Last Updated: June 20, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014