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

NCT ID: NCT01847287

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Tysabri

All subjects took Tysabri and also had an MRI which we use for the baseline evaluation. Over 5 years, some patients remained on Tysabri, some started another drug and others were off Tysabri for a time but then restarted.

No interventions assigned to this group

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Robert Zivadinov, MD, PhD

Director, Buffalo Neuroimaging Analysis Center, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Countries

United States

Other Identifiers

TST5

Identifier Type: -

Identifier Source: org_study_id