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

NCT01847287 | Completed

• 1 other identifier: TST5
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Tysabri; MRI; Natalizumab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis - relapsing remitting

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 6, 2013
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

US (1)