Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis (JapanExtension)
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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 |
- 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 ]
- 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 |
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| Contact: Biogen Idec MD, MS | neurologyclinicaltrials@biogenidec.com |
| 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 | |
More Information
No publications provided
| Responsible Party: | Biogen Idec Inc, 14 Cambridge Center, Cambridge, MA, 02142, USA |
| ClinicalTrials.gov Identifier: | NCT01416155 History of Changes |
| Other Study ID Numbers: | 101MS204 |
| Study First Received: | March 24, 2011 |
| Last Updated: | June 7, 2012 |
| 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 June 18, 2013