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
Completed
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02308670
- Run by
- University at Buffalo
- People needed
- 150
- Starts
- 2014-07-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.