Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Exclusion Criteria

• •Another type of MS other than relapsing remitting multiple sclerosis (RRMS)
• •A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome/immunocompromised
• •A history or presence of cancer (except for successfully treated basal or squamous cell carcinoma of skin)
• •Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
• •Have received any live or live attenuated vaccines (including for varicella-zoster virus or Measles) within the last 2 months
• •Have received total lymphoid irradiation or bone marrow transplantation
• •Have been treated with: corticosteroids or adrenocorticotropic hormones (ACTH) within the last month, IFN-β or glatiramer acetate within the last 3 months, immunosuppressive medications such as azathioprine or methotrexate within the last 6 months, immunoglobulins and/or monoclonal antibodies (including natalizumab) within the last 6 months, or cladribine, cyclophosphamide or mitoxantrone at any time.
• •Any medically unstable condition or a progressive neurological disorder, other than MS, which may affect participation in the study
• •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease
• •Unable to undergo MRI scans, including claustrophobia, have a pacemaker or history of hypersensitivity to gadolinium-DTPA
• •Have had a relapse within 30 days prior AND/OR not stabilized from a previous relapse
• •History of severe allergic or anaphylactic reactions or known drug hypersensitivity to natalizumab/Tysabri
• •A clinically significant infectious disease, such as cellulitis, pneumonia, septicemia
• •History of progressive multifocal leukoencephalopathy(PML)
• •Participation in any clinical research study evaluating another investigational drug or therapy within the last 6 months
• •History of Tysabri therapy
• •Abnormal screening blood test
• •Females who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study
• •Nursing mothers, pregnant women, and women planning to become pregnant while on study