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

NCT00463710 | Completed

• 1 other identifier: 003-05-AVX
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

MTI, DWI, Avonex, MRI

Interventions

Avonex® monotherapy (6.0 MIU administered i.m. each week) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Biogen: collaborator

Study Sites (1)

The Jacobs Neurological Institute

Buffalo, New York, 14127, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Driving Under the Influence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Criminal Behavior; Behavior; Dangerous Behavior

Study Officials

• Robert Zivadinov, MD, PhD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: June 1, 2005
• Study Completion: September 1, 2006
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

US (1)