observational study of tysabri in early relapsing-remitting multiple sclerosis in anti-jc virus antibody negative participants

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at month 12 and month 24, and clinical disease-free status in subsequent months 36 and 48. the secondary objectives are: to identify prognostic factors at baseline that predict overall disease-free status at month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at month 24; to evaluate clinical disease-free status (relapse, expanded disability status scale \[edss\]) at each analysis time point of months 12, 24, 36, and 48; to identify prognostic factors at baseline that predict clinical disease-free status at month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, edss) in subsequent years at months 24, 36, and 48; to evaluate the impact of tysabri at each analysis time point of months 12, 24, 36, and 48 on the following: annualized relapse rate (arr), sustained edss progression and improvement (24-week sustained); to evaluate the impact of tysabri at each analysis time point of months 12, 24, 36, and 48 on the following: magnetic resonance image (mri) measures: t2, t1, t1 with gadolinium (gd), brain atrophy; to evaluate the impact of tysabri at month 24 and month 48 on the following: optical coherence tomography (oct), low and high contrast visual acuity assessment; to evaluate the impact of tysabri at each analysis time point of months 12, 24, 36, and 48 on the following: cognitive impairment (symbol digit modalities test \[sdmt\]), capacity for work (work productivity and activity impairment questionnaire \[wpai\]), quality of life (qol) (multiple sclerosis impact scale \[msis-29\])


Eligibility criteria:
key inclusion criteria: * documented diagnosis of relapsing multiple sclerosis (mcdonald 2010 criteria ). * \<3 year disease duration. * must have an expanded disability status scale (edss) score from 0 to 4.0, inclusive. * anti-jcv antibody negative test within 6 months of screening visit. * must satisfy the approved therapeutic indications for tysabri. * must be treatment-naïve to disease-modifying therapy (dmt) or have been treated with dmt (including but not limited to avonex, betaseron, rebif, copaxone, extavia, or gilenya) for ≤36 months total prior to date of informed consent. * decision to treat with tysabri must precede enrollment. key exclusion criteria: * any prior treatment with tysabri. * anti-jcv antibody positive at any timepoint prior to the screening visit. * contraindications to treatment with tysabri as described in the us prescribing information. * history of progressive multifocal leukoencephalopathy (pml) or other opportunistic infections, or an increased risk for such infections. * history of diagnosis of primary progressive multiple sclerosis (ppm) and/or secondary progressive multiple sclerosis (spms). * receiving immunomodulatory or immunosuppressive therapy. * prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab). * immunocompromised at the time of enrollment. * known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible). * women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception. * inability to comply with study requirements. note: other protocol defined inclusion/exclusion criteria may apply.