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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:
Collaborator:
Biogen Idec
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00463710
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
Investigators
Principal Investigator: Robert Zivadinov, MD, PhD SUNY Buffalo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463710     History of Changes
Other Study ID Numbers: 003-05-AVX
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013