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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01847287

Acronym

TST

Enrollment

Registered

2013-05-06

Start date

2012-05-31

Completion date

2013-02-28

Last updated

2013-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Tysabri, MRI, Natalizumab

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).	5 years	Evaluation of MRI images from baseline in comparison with a 5 year MRI.

Secondary

Measure	Time frame	Description
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.	5 years	To evaluate any effect of the number of Tysabri cycles on lesion volume.

Countries

United States

Outcome results