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Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study

NCT00937677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2011-09-07

No results posted yet for this study

Summary

The primary objective of this study is to define the effect of Tysabri in patients with relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also explore the extent of remyelination in MS patients treated with Tysabri over 2 years.

A secondary objective of this study is to investigate differences in the capacity for remyelination between patients who do or do not respond to Tysabri monotherapy during the same 24 months.

A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid antibodies positive and MS antiphospholipid antibodies negative patients and to determine perfusion differences according to the antiphospholipid antibodies positivity status.

Conditions

Interventions

DRUG

Tysabri

Infusion of TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour at month 0 and 12 and 24 months. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI®. TYSABRI® concentrate is supplied as 300 mg natalizumab in a sterile, single-use vial free of preservatives. Each package contains a single-use vial.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • University at Buffalo

    lead OTHER

Principal Investigators

  • Robert Zivadinov, MD, PHd · University at Buffalo

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-12-31
Completion
2010-11-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937677 on ClinicalTrials.gov