safety and efficacy of natalizumab (bg00002, tysabri®) in russian participants with relapsing remitting multiple sclerosis (rrms)

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective is to evaluate the safety and tolerability of natalizumab (bg00002, tysabri®) in the study population (russian participants with relapsing remitting multiple sclerosis). the secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; expanded disability status scale (edss), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (sf-36) and multiple sclerosis impact scale 29 (msis-29), evidence of mri disease activity, participants free of disease activity (clinical activity and/mri activity) and anti jc virus (jcv) antibody evaluation.


Eligibility criteria:
key inclusion criteria: * must be natalizumab naïve. * must have a documented diagnosis of a relapsing remitting form of ms as defined by the revised mcdonald committee criteria (polman et al., 2011) * must have had at least 1 relapse in the previous year: * must be stable in disability for at least 30 days prior to enrollment to the study * must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study. * must be considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (pml) based on medical history, physical examination, or laboratory testing. * must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including ifn-beta and glatiramer acetate) while being treated with natalizumab during the study. key exclusion criteria: medical history: * onset of a relapse within 50 days prior to first infusion. * considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment * history of, or available abnormal laboratory results indicative of, any significiant viral, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. the investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment. * history of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible) * known history of human immunodeficiency virus infection or hematological malignancy * history of organ transplantation (including anti-rejection therapy) * a clinically significant infectious illness (e.g. abscess, pneumonia, septicemia) within 30 days prior to the screening visit. treatment history: - treatment with any kind of immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, fingolimod, cladribine) within 6 months prior to screening miscellaneous: * female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or unwilling to practice effective contraception (as defined by the investigator) during the study * women who are breastfeeding, pregnant, or planning to become pregnant while on study * other unspecified reasons that, in the opinion of the investigator and/or biogen idec, make the subject unsuitable for enrollment into this study. note: other protocol defined inclusion/exclusion criteria may apply