Status:
COMPLETED
Effect of Interferon Beta-1a (Avonex®) on Changes of Non-conventional MRI Measures in Patients With MS
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
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 tw...
Detailed Description
1.1. Protocol Title: Effect of Interferon beta-1a (Avonex®) on changes of non-conventional MRI measures in patients with relapsing-remitting and secondary-progressive multiple sclerosis. 1.2. Study r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
End Date :
September 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00463710
Start Date
June 1 2005
End Date
September 1 2006
Last Update
December 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Jacobs Neurological Institute
Buffalo, New York, United States, 14127