A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years

Study Overview
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Brief Summary
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The primary aim of this study is to evaluate the effect of using Tysabri on changes in the brain using MRI and on disease progression in patients with relapsing-remitting Multiple Sclerosis over 5 years.

Detailed Description
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This is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.

Official Title
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A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in natalizumab 1-year follow-up study Participants were aged 18-65 Have clinically definite MS according to the Polman criteria of either RR or RSP disease type EDSS scores ≤6.5 disease duration <30 years normal kidney function (creatinine clearance >59 mL/min) started therapy either with natalizumab or IM interferon beta-1a (IFNβ-1a) Signed informed consent Normal kidney functioning (creatinine clearance >59) None of the exclusion criteria Exclusion Criteria: A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to 5-year follow-up visit Nursing mothers or pregnant women who will need to undergo 5-year follow-up MRI 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 Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tysabri<br>All subjects took Tysabri and also had an MRI which we use for the baseline evaluation. Over 5 years, some patients remained on Tysabri, some started another drug and others were off Tysabri for a time but then restarted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of this study is to define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis (MS). | Evaluation of MRI images from baseline in comparison with a 5 year MRI. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is to define the effect of the number of natalizumab cycles on accumulation of T2-LV and T1-LV and their VW-MTR changes over 5 years. | To evaluate any effect of the number of Tysabri cycles on lesion volume. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Tysabri, MRI, Natalizumab