Status:
COMPLETED
A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years
Lead Sponsor:
University at Buffalo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 yea...
Detailed Description
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, whic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01847287
Start Date
May 1 2012
End Date
February 1 2013
Last Update
May 7 2013
Active Locations (1)
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1
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203