Clinical trial NCT01847287: A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years
Official title: A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Tysabri
MRI
Natalizumab
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis - relapsing remitting

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 years.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
References: