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A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

NCT ID: NCT03257358

Last Updated: 2021-10-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2019-06-28

Brief Summary

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A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

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Detailed Description

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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..

Conditions

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two-cohort, non-randomized, open-label multicenter
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day

Group Type OTHER

Fingolimod

Intervention Type DRUG

Commercially available 0.5mg hard capsules, taken orally once per day

Cohort 2

RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years

Group Type OTHER

Fingolimod

Intervention Type DRUG

Commercially available 0.5mg hard capsules, taken orally once per day

Interventions

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Fingolimod

Commercially available 0.5mg hard capsules, taken orally once per day

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Cullman, Alabama, United States

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Tucson, Arizona, United States

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Berkeley, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Louisville, Colorado, United States

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Boca Raton, Florida, United States

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Boca Raton, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Sunrise, Florida, United States

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Vero Beach, Florida, United States

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Savannah, Georgia, United States

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Suwanee, Georgia, United States

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Flossmoor, Illinois, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Lutherville, Maryland, United States

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Foxborough, Massachusetts, United States

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Lexington, Massachusetts, United States

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Wellesley, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Owosso, Michigan, United States

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Golden Valley, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Fair Lawn, New Jersey, United States

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Livingston, New Jersey, United States

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Patchogue, New York, United States

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Plainview, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Mooresville, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Westerville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Port Royal, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Vienna, Virginia, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Huntington, West Virginia, United States

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Green Bay, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Novartis Investigative Site

Neenah, Wisconsin, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=558

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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CFTY720DUS40

Identifier Type: -

Identifier Source: org_study_id

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