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

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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..

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

382

Study ID:

NCT03257358

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 66 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35209, United States
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Cullman Alabama, 35058, United States
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Tucson Arizona, 85718, United States
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Berkeley California, 94705, United States
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Sacramento California, 95817, United States
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Colorado Springs Colorado, 80907, United States
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Louisville Colorado, 80027, United States
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Boca Raton Florida, 33482, United States
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Boca Raton Florida, 33487, United States
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Jacksonville Florida, 32209, United States
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Miami Florida, 33136, United States
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Ocala Florida, 34471, United States
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Port Charlotte Florida, 33952, United States
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Sarasota Florida, 34243, United States
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Sunrise Florida, 33351, United States
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Vero Beach Florida, 32960, United States
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Savannah Georgia, 31406, United States
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Suwanee Georgia, 30024, United States
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Flossmoor Illinois, 60422, United States
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Kansas City Kansas, 66160, United States
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Louisville Kentucky, 40202, United States
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Louisville Kentucky, 40207, United States
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Lutherville Maryland, 21093, United States
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Foxboro Massachusetts, 02035, United States
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Lexington Massachusetts, 02421, United States
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Wellesley Massachusetts, 02481, United States
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Ann Arbor Michigan, 48109, United States
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Owosso Michigan, 48867, United States
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Golden Valley Minnesota, 55422, United States
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Kansas City Missouri, 64111, United States
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Saint Louis Missouri, 63131, United States
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Las Vegas Nevada, 89106, United States
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Fair Lawn New Jersey, 07410, United States
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Livingston New Jersey, 07039, United States
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Patchogue New York, 11772, United States
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Plainview New York, 11803, United States
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Asheville North Carolina, 28806, United States
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Charlotte North Carolina, 28207, United States
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Mooresville North Carolina, 28117, United States
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Raleigh North Carolina, 27607, United States
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Winston-Salem North Carolina, 27103, United States
Novartis Investigative Site
Cleveland Ohio, 44195, United States
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Dayton Ohio, 45408, United States
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Toledo Ohio, 43623, United States
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Westerville Ohio, 43081, United States
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Oklahoma City Oklahoma, 73102, United States
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Oklahoma City Oklahoma, 73104, United States
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Portland Oregon, 97225, United States
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Philadelphia Pennsylvania, 19140, United States
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Greer South Carolina, 29650, United States
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Mount Pleasant South Carolina, 29464, United States
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Port Royal South Carolina, 29935, United States
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Knoxville Tennessee, 37922, United States
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Nashville Tennessee, 37215, United States
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Dallas Texas, 75246, United States
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San Antonio Texas, 78258, United States
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Falls Church Virginia, 22043, United States
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Vienna Virginia, 22182, United States
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Kirkland Washington, 98034, United States
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Seattle Washington, 98122, United States
Novartis Investigative Site
Spokane Washington, 99202, United States
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Tacoma Washington, 98405, United States
Novartis Investigative Site
Huntington West Virginia, 25701, United States
Novartis Investigative Site
Green Bay Wisconsin, 54311, United States
Novartis Investigative Site
Milwaukee Wisconsin, 53215, United States
Novartis Investigative Site
Neenah Wisconsin, 54956, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

382

Study ID:

NCT03257358

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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