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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01847287

Run by

University at Buffalo

People needed

60

Starts

2012-05-01

Expected to finish

2013-02-01

Last updated by the study team

2013-05-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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