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Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With MS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463710
First Posted: April 20, 2007
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by:
State University of New York at Buffalo
  Purpose
Phase IV open label, single-blind study, post-marketing, 1-year MRI observational study evaluating effect of Avonex® monotherapy (6.0 MIU administered i.m. each week) on the year-to-year changes in two annual measures—magnetization transfer imaging and diffusion-weighted imaging in patients with either relapsing-remitting (RR) or secondary-progressive (SP) multiple sclerosis (MS). One hundred fifty (150) patients with RR and SP MS—followed at the Jacobs Neurological Institute, University at Buffalo, Buffalo NY—who satisfy both inclusion and exclusion criteria will be included. They will be assessed at baseline and at 12 months with MRI and clinical examinations.

Condition Intervention Phase
Multiple Sclerosis Drug: Avonex® monotherapy (6.0 MIU administered i.m. each week) Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With Relapsing-Remitting and Secondary-Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Estimated Enrollment: 150
Study Start Date: June 2005
Study Completion Date: September 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient diagnosed with clinical definite MS according to the McDonald criteria
  • Age 18-65
  • Have a RR or SP disease course
  • Have EDSS scores less than or equal to 6.5
  • Have disease duration 6 months to 20 years
  • Be on intramuscular 6 MIU of Avonex® for a minimum of 3-6 months before the study entry
  • Signed informed consent
  • None of the exclusion criteria

Exclusion Criteria:

  • Previous treatment 3 months prior to study entry with immunosuppressant agents, e.g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies besides Avonex® (e.g., Azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc).
  • Patients who received steroid therapy during the 3 months prior to study entry or patients who received steroid treatment 30-60 days prior to the follow-up MRI scan date.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463710


Locations
United States, New York
The Jacobs Neurological Institute
Buffalo, New York, United States, 14127
Sponsors and Collaborators
State University of New York at Buffalo
Biogen
Investigators
Principal Investigator: Robert Zivadinov, MD, PhD SUNY Buffalo
  More Information

ClinicalTrials.gov Identifier: NCT00463710     History of Changes
Other Study ID Numbers: 003-05-AVX
First Submitted: April 19, 2007
First Posted: April 20, 2007
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by State University of New York at Buffalo:
MTI, DWI, Avonex, MRI

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic