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

Multiple Sclerosis Clinical Trial

— TST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847287
• Other study ID #: TST5
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: May 6, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: SUNY University at Buffalo Health Sciences Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 (IFNß-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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Buffalo Neuroimaging Analysis Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No