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Sponsors and Collaborators: |
State University of New York at Buffalo Biogen Idec |
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Information provided by: | State University of New York at Buffalo |
ClinicalTrials.gov Identifier: | NCT00463710 |
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 |
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Multiple Sclerosis |
Drug: Avonex® monotherapy (6.0 MIU administered i.m. each week) |
Phase IV |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | June 2005 |
Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
The Jacobs Neurological Institute | |
Buffalo, New York, United States, 14127 |
Principal Investigator: | Robert Zivadinov, MD, PhD | SUNY Buffalo |
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 |
MTI, DWI, Avonex, MRI |
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 |
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 |