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

This study has been completed.

Sponsors and Collaborators:	State University of New York at Buffalo Biogen Idec
Information provided by:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT00463710

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 IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta Interferon beta 1a

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
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

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

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

Keywords provided by State University of New York at Buffalo:

MTI, DWI, Avonex, MRI

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta 1a
Interferon-beta

Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009