Effect of Interferon Beta-1a (Avonex®) on Changes of Non-conventional MRI Measures in Patients With MS
Completed
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00463710
- Run by
- State University of New York at Buffalo
- People needed
- 150
- Starts
- 2005-06-01
- Expected to finish
- 2006-09-01
- Last updated by the study team
- 2020-12-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
- None of the exclusion criteria
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.
Where it is running
- The Jacobs Neurological Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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