Multiple Sclerosis Clinical Trial
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Summary
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod
Full Description
This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The first cohort was to be comprised of approximately 200 patients with RMS, who were newly prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to be comprised of approximately 200 RMS patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..
Eligibility Criteria
Inclusion Criteria:
Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years
Exclusion Criteria (per USPI):
Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
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There are 66 Locations for this study
Birmingham Alabama, 35209, United States
Cullman Alabama, 35058, United States
Tucson Arizona, 85718, United States
Berkeley California, 94705, United States
Sacramento California, 95817, United States
Colorado Springs Colorado, 80907, United States
Louisville Colorado, 80027, United States
Boca Raton Florida, 33482, United States
Boca Raton Florida, 33487, United States
Jacksonville Florida, 32209, United States
Miami Florida, 33136, United States
Ocala Florida, 34471, United States
Port Charlotte Florida, 33952, United States
Sarasota Florida, 34243, United States
Sunrise Florida, 33351, United States
Vero Beach Florida, 32960, United States
Savannah Georgia, 31406, United States
Suwanee Georgia, 30024, United States
Flossmoor Illinois, 60422, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40207, United States
Lutherville Maryland, 21093, United States
Foxboro Massachusetts, 02035, United States
Lexington Massachusetts, 02421, United States
Wellesley Massachusetts, 02481, United States
Ann Arbor Michigan, 48109, United States
Owosso Michigan, 48867, United States
Golden Valley Minnesota, 55422, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63131, United States
Las Vegas Nevada, 89106, United States
Fair Lawn New Jersey, 07410, United States
Livingston New Jersey, 07039, United States
Patchogue New York, 11772, United States
Plainview New York, 11803, United States
Asheville North Carolina, 28806, United States
Charlotte North Carolina, 28207, United States
Mooresville North Carolina, 28117, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27103, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45408, United States
Toledo Ohio, 43623, United States
Westerville Ohio, 43081, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19140, United States
Greer South Carolina, 29650, United States
Mount Pleasant South Carolina, 29464, United States
Port Royal South Carolina, 29935, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37215, United States
Dallas Texas, 75246, United States
San Antonio Texas, 78258, United States
Falls Church Virginia, 22043, United States
Vienna Virginia, 22182, United States
Kirkland Washington, 98034, United States
Seattle Washington, 98122, United States
Spokane Washington, 99202, United States
Tacoma Washington, 98405, United States
Huntington West Virginia, 25701, United States
Green Bay Wisconsin, 54311, United States
Milwaukee Wisconsin, 53215, United States
Neenah Wisconsin, 54956, United States
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