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Inclusion Criteria:
- 18 through 60 years of age inclusive
- Diagnosis of relapsing remitting multiple sclerosis
- Prior to treatment phase, have had disease activity with at least 1 documented
relapse during the previous year OR 2 documented relapses during the previous 2 years
OR one or more new MRI lesions (Gd+ and/or T2 hyperintense)
- An Expanded Disability Status Scale (EDSS) score of 0-4.5 inclusive
- Neurologically stable with no evidence of relapse or corticosteroid treatment within
30 days prior to treatment
- Never been treated with Tysabri/natalizumab.
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
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