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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Biogen Idec.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01416155
First received: March 24, 2011
Last updated: September 12, 2013
Last verified: September 2011
  Purpose

This will be a multicenter, long-term, open-label extension study in subjects who have successfully completed Study 101MS203 (randomised, double blind study and placebo controlled multi-dose evaluation of BG00002 in patients with RRMS). Only subjects from Study 101MS203 who meet the eligibility requirements will be enrolled, no new subjects will be enrolled into this study.


Condition Intervention
Multiple Sclerosis
Biological: BG00002

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 subjects with adverse events as a measure of safety and tolerability [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Changes in Physical Examinations as a measure of general health [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Changes in Neurological Examinations as a measure of MS status [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Changes in ECGs as a measure of cardiac health [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Changes in blood biochemistry and haematology as a measure of general health [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Measurement of anti-BG00002 antibodies [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical relapse assessments as a measure of MS status [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: Yes ]
  • Assessment of Expanded Disability Status Scale (EDSS) as a measure MS status [ Time Frame: Every 12 weeks for approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00002
300mg IV infusions of BG00002 every 4 weeks
Biological: BG00002
recombinant humanized anti-alpha4 integrin antibody

Detailed Description:

Biogen Idec is conducting a Phase 2 study in Japan, Study 101MS203, that is designed to provide data in Japanese subjects to support registration of BG00002 in Study Rationale To further evaluate the safety and efficacy profile of BG00002 in Japanese subjects for registration of BG00002 in Japan.

Primary Objective The primary objective of the study is to further evaluate the long-term safety and tolerability profiles of BG00002 in Japanese subjects with RRMS.

Secondary Objective(s) Secondary objective of this study in this study population is to further evaluate the long-term efficacy profile of BG00002 in Japanese subjects with RRMS.

  Eligibility

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

Inclusion Criteria

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorisations required by local law. Subjects who participated in and completed all protocol-related evaluations through Week 24 of Study 101MS203.
  • 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 IFNβ and long-term systemic corticosteroids) for the duration of the study.

Exclusion Criteria

  • Any significant change in medical history since Study 101MS203, 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 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 with any of the following medications between last dose of study treatment in Study 101MS203 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 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 product.
  • 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 enrolment into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416155

Contacts
Contact: Biogen Idec MD, MS neurologyclinicaltrials@biogenidec.com

Locations
Japan
Research Site Recruiting
Chiba,, Japan
Research Site Recruiting
Fukuoka,, Japan
Research Site Recruiting
Hiroshima,, Japan
Research Site Recruiting
Kawagoe,, Japan
Research Site Recruiting
Kodaira,, Japan
Research Site Recruiting
Kyoto,, Japan
Research Site Recruiting
Morioka,, Japan
Research Site Recruiting
Niigata,, Japan
Research Site Recruiting
Osaka,, Japan
Research Site Recruiting
Sapporo,, Japan
Research Site Recruiting
Sendai,, Japan
Research Site Recruiting
Suita,, Japan
Research Site Recruiting
Tokorozawa,, Japan
Research Site Recruiting
Tokyo,, Japan
Research Site Recruiting
Tsukuba,, Japan
Research Site Recruiting
Ube,, Japan
Research Site Recruiting
Yokohama,, Japan
Sponsors and Collaborators
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: September 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

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

ClinicalTrials.gov processed this record on April 17, 2014