Status:
COMPLETED
Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week in Subjects With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
Detailed Description
The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus patho...
Eligibility Criteria
Inclusion
- MS patients diagnosed with MS according to the McDonald criteria
- MS patients having a relapsing disease course
- Being on GA monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care MRI at the time of switch to GA 40mg x 3/weekly
- Having standard of care 3T MRI scan while on GA 20mg/daily treatment for at least 12-18 months prior to the start day of the of the GA 40mg x 3/weekly and at the time of switch to GA 40mg x 3/weekly Age over 18
- Pass MRI health screening (in case of EGFR \<59, the contrast will not be applied)
- None of the exclusion criteria
Exclusion
- Patients who had a relapse within 30 days prior to MRI scan date
- Patients who received steroid treatment within 30 days prior to the MRI scan date
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
- MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the 12 months prior to start of GA 40mg 3/weekly (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02308670
Start Date
July 1 2014
End Date
October 1 2016
Last Update
October 25 2016
Active Locations (1)
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1
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203