Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
Completed
Conditions studied: Multiple Sclerosis
In brief
The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.
Key facts
- Study ID
- NCT02776072
- Run by
- Biogen
- People needed
- 2978
- Starts
- 2016-05-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Gilbert, Arizona, United States
- Research Site — Hanford, California, United States
- Research Site — Modesto, California, United States
- Research Site — Santa Ana, California, United States
- Research Site — Aurora, Colorado, United States
- Research Site — Danbury, Connecticut, United States
- Research Site — Hartford, Connecticut, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Port Orange, Florida, United States
- Research Site — Savannah, Georgia, United States
- Research Site — Avon, Indiana, United States
- Research Site — Franklin, Indiana, United States
- Research Site — Muncie, Indiana, United States
- Research Site — Overland Park, Kansas, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Wellesley, Massachusetts, United States
- Research Site — Golden Valley, Minnesota, United States
- Research Site — Amherst, New York, United States
- Research Site — New Hyde Park, New York, United States
- Research Site — New York, New York, United States
- Research Site — Patchogue, New York, United States
- Research Site — Raleigh, North Carolina, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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